Trial Outcomes & Findings for Trial to Evaluate L9LS in Healthy Adults (NCT NCT05019729)
NCT ID: NCT05019729
Last Updated: 2024-08-14
Results Overview
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
7 days after L9LS product administration, at approximately Week 1
Results posted on
2024-08-14
Participant Flow
Healthy adults were recruited for the study at the NIH Clinical Center in Bethesda, Maryland, USA.
Participant milestones
| Measure |
Group 1: L9LS (1 mg/kg IV)
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 5: CHMI Controls
Control participants who did not receive L9LS and were enrolled to complete the controlled human malaria infection (CHMI)
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
5
|
4
|
9
|
5
|
|
Overall Study
Received Product Administration
|
5
|
4
|
5
|
4
|
0
|
5
|
|
Overall Study
Completed Controlled Human Malaria Infection (CHMI)
|
5
|
3
|
5
|
4
|
6
|
0
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
4
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group 1: L9LS (1 mg/kg IV)
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 5: CHMI Controls
Control participants who did not receive L9LS and were enrolled to complete the controlled human malaria infection (CHMI)
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|---|
|
Overall Study
Back up control participants who did not receive L9LS or CHMI because they were not needed
|
0
|
0
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Weight was not collected for Group 5 control participants in this protocol. Per protocol, weight was only collected for participants who received L9LS.
Baseline characteristics by cohort
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 5: CHMI Controls
n=9 Participants
Control participants who did not receive L9LS and were enrolled to complete the controlled human malaria infection (CHMI)
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
23.4 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
25.3 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
26.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 3.2 • n=4 Participants
|
22.9 years
STANDARD_DEVIATION 0.9 • n=9 Participants
|
34.4 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
25.8 years
STANDARD_DEVIATION 6.7 • n=32 Participants
|
|
Age, Customized
21-30 years
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
2 Participants
n=5 Participants
|
28 Participants
n=32 Participants
|
|
Age, Customized
31-40 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=32 Participants
|
|
Age, Customized
41-50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
4 Participants
n=5 Participants
|
25 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=32 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=32 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=32 Participants
|
|
Weight (kg)
|
62.6 kg
STANDARD_DEVIATION 7.6 • n=5 Participants • Weight was not collected for Group 5 control participants in this protocol. Per protocol, weight was only collected for participants who received L9LS.
|
72.2 kg
STANDARD_DEVIATION 16.4 • n=4 Participants • Weight was not collected for Group 5 control participants in this protocol. Per protocol, weight was only collected for participants who received L9LS.
|
59.2 kg
STANDARD_DEVIATION 10.4 • n=5 Participants • Weight was not collected for Group 5 control participants in this protocol. Per protocol, weight was only collected for participants who received L9LS.
|
76.7 kg
STANDARD_DEVIATION 2.9 • n=4 Participants • Weight was not collected for Group 5 control participants in this protocol. Per protocol, weight was only collected for participants who received L9LS.
|
—
|
82.9 kg
STANDARD_DEVIATION 6.9 • n=5 Participants • Weight was not collected for Group 5 control participants in this protocol. Per protocol, weight was only collected for participants who received L9LS.
|
70.4 kg
STANDARD_DEVIATION 12.7 • n=23 Participants • Weight was not collected for Group 5 control participants in this protocol. Per protocol, weight was only collected for participants who received L9LS.
|
PRIMARY outcome
Timeframe: 7 days after L9LS product administration, at approximately Week 1Population: Population included all enrolled participants who received L9LS and had safety data collected via diary card (N=23). Group 5 CHMI controls did not receive L9LS.
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pain/Tenderness · None
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pain/Tenderness · Mild
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pain/Tenderness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pruritis (Itching) · None
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pruritis (Itching) · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pruritis (Itching) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Pruritis (Itching) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Swelling · None
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Redness · None
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Bruising · None
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Bruising · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Bruising · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Local Symptom · None
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Local Symptom · Mild
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Local Symptom · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Local Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Bruising · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days after L9LS product administration, at approximately Week 1Population: Population included all enrolled participants who received L9LS and had safety data collected via diary card (N=23). Group 5 CHMI controls did not receive L9LS.
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Malaise · None
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Malaise · Mild
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Malaise · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Malaise · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Muscle Aches · None
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Muscle Aches · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Muscle Aches · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Headache · None
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Headache · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Headache · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Chills · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Nausea · None
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Nausea · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Joint Pain · None
|
5 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Joint Pain · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Joint Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Temperature (Fever) · None
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Temperature (Fever) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Temperature (Fever) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Temperature (Fever) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Systemic Symptom · None
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Systemic Symptom · Mild
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Systemic Symptom · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Any Systemic Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Muscle Aches · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Chills · None
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 4 weeks after L9LS product administrationPopulation: Population included all enrolled participants who received L9LS and had safety data collected via clinical assessment and/or lab results (N=23). Group 5 CHMI controls did not receive L9LS.
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 28 post-product administration visit. At other time periods between study product administration and when greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following L9LS Product Administration
Related to Study Product
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following L9LS Product Administration
Unrelated to Study Product
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following L9LS Product Administration
Total Number of Participants who had One or More Non-Serious Unsolicited AE after L9LS
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 4 weeks after CHMIPopulation: Population included all participants who completed CHMI (N=23). One Group 2 participant declined to participate in the CHMI prior to the scheduled pre-CHMI visit and therefore was not enrolled in the CHMI group. Group 6 L9LS (5mg/kg IM) participants did not participate in the CHMI.
Unsolicited adverse event (AE) data collection included AEs of all severities from CHMI through the Day 28 post-CHMI visit. The relationship between an AE and CHMI was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=3 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=6 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Controlled Human Malaria Infection (CHMI)
Related to CHMI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Controlled Human Malaria Infection (CHMI)
Unrelated to CHMI
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Controlled Human Malaria Infection (CHMI)
Total Number of Participants who had One or More Non-Serious Unsolicited AE after CHMI
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 after L9LS product administration through the study participation, up to Week 24Population: Population included all enrolled participants who received L9LS and had safety data collected via clinical assessment and/or lab results (N=23). Group 5 CHMI controls did not receive L9LS.
SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 24. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Following L9LS Product Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 after L9LS product administration through the study participation, up to Week 24Population: Population included all enrolled participants who received L9LS and had safety data collected via clinical assessment and/or lab results (N=23). Group 5 CHMI controls did not receive L9LS.
New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants With New Chronic Medical Conditions Following L9LS Product Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 4 weeks after L9LS product administrationPopulation: Population included all enrolled participants who received L9LS and had safety data collected via laboratory results (N=23).
Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (Comprehensive Metabolic Panel (CMP) including alanine aminotransferase (ALT) and creatinine). Complete Blood Count (CBC) with differential, CMP and ALT and creatinine results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following L9LS Product Administration
Creatinine
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following L9LS Product Administration
Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following L9LS Product Administration
Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following L9LS Product Administration
Alanine Aminotransferase (ALT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following L9LS Product Administration
Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 21 days after CHMIPopulation: Population included all participants who completed CHMI (N=23). One Group 2 participant declined to participate in the CHMI prior to the scheduled pre-CHMI visit and therefore was not enrolled in the CHMI group. Group 6 L9LS (5mg/kg IM) participants did not participate in the CHMI.
Parasitemia as determined by polymerase chain reaction (PCR) up to day 21 following CHMI to determine whether IV or SC administration of L9LS mediates protection against infectious P. falciparum following CHMI
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=3 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=6 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Number of Participants Who Developed Plasmodium Falciparum (P. Falciparum) Parasitemia Following Controlled Human Malaria Infection (CHMI) Challenge
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after L9LS product administrationPopulation: Population included all participants who received L9LS (N=23).
Serum concentrations of L9LS by dose group following a single administration. Cmax is the peak serum concentration that L9LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of L9LS: Maximum Observed Serum Concentration (Cmax)
|
41.5 μg/ml
Standard Deviation 4.7
|
164.9 μg/ml
Standard Deviation 31.1
|
66.5 μg/ml
Standard Deviation 3.3
|
914.2 μg/ml
Standard Deviation 146.5
|
68.9 μg/ml
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after L9LS product administrationPopulation: Population included all participants who received L9LS (N=23).
Tmax is the time it takes to reach Cmax of L9LS after it has been administered; it is determined based on the summary PK curve for each dose group.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of L9LS: Time to Reach Maximum Observed Serum Concentration (Tmax)
|
0.08 days
Standard Deviation 0.06
|
0.06 days
Standard Deviation 0.06
|
9.94 days
Standard Deviation 4.06
|
0.08 days
Standard Deviation 0.04
|
5.86 days
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after L9LS product administrationPopulation: Population included all participants who received L9LS (N=23).
Beta half-life (T1/2b) is being reported for this study. Beta half-life (T1/2b) is the time required for half of the L9LS product to be eliminated from the serum.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 Participants
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 Participants
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of L9LS: Beta Half-life (T1/2b)
|
62.06 days
Standard Deviation 6.29
|
70.57 days
Standard Deviation 8.83
|
73.39 days
Standard Deviation 16.93
|
59.45 days
Standard Deviation 7.38
|
66.95 days
Standard Deviation 2.54
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after L9LS product administrationPopulation: Population included participants who received L9LS (1 mg/kg IV, 5 mg/kg IV, and 20 mg/kg IV) intravenously (N=13).
Rate of L9LS elimination divided by the plasma L9LS concentration; determined based on the summary pharmacokinetic (PK) curve for each IV group.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=4 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of L9LS: Clearance (CL) Following IV Administration
|
35.38 ml/day
Standard Deviation 3.46
|
43.54 ml/day
Standard Deviation 10.51
|
40.48 ml/day
Standard Deviation 4.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after L9LS product administrationPopulation: Population included participants who received either L9LS (5 mg/kg SC and 5 mg/kg IM) subcutaneously or intramuscularly (N=10).
Rate of L9LS elimination divided by the plasma L9LS concentration; determined based on the summary pharmacokinetic (PK) curve for each SC and IM group. Clearance following a SC or IM administration is calculated as Clearance (CL)/Bioavailability (F).
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=5 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of L9LS: Clearance (CL/F) Following SC or IM Administration
|
45.87 ml/day
Standard Deviation 7.17
|
60.70 ml/day
Standard Deviation 4.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after L9LS product administrationPopulation: Population included participants who received L9LS (1 mg/kg IV, 5 mg/kg IV, and 20 mg/kg IV) intravenously (N=13).
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the pharmacokinetic (PK) curve for each IV group.
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=4 Participants
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of L9LS: Volume of Distribution at Steady-State (Vss) Following IV Administration
|
3.13 Liters
Standard Deviation 0.50
|
4.43 Liters
Standard Deviation 1.56
|
3.42 Liters
Standard Deviation 0.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after L9LS product administrationPopulation: Population included participants who received either L9LS (5 mg/kg SC and 5 mg/kg IM) subcutaneously or intramuscularly (N=10).
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each SC and IM group. Volume of distribution at steady-state (Vss) following a SC or IM administration is calculated as Volume of distribution at steady-state (Vss)/Bioavailability (F).
Outcome measures
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 Participants
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=5 Participants
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of L9LS: Volume of Distribution at Steady-State (Vss/F) Following SC or IM Administration
|
4.70 Liters
Standard Deviation 0.84
|
5.77 Liters
Standard Deviation 0.48
|
—
|
—
|
—
|
Adverse Events
Group 1: L9LS (1 mg/kg IV)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: L9LS (5 mg/kg IV)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3: L9LS (5 mg/kg SC)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4: L9LS (20 mg/kg IV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 5: CHMI Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 6: L9LS (5 mg/kg IM)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: L9LS (1 mg/kg IV)
n=5 participants at risk
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 2: L9LS (5 mg/kg IV)
n=4 participants at risk
L9LS (5 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 3: L9LS (5 mg/kg SC)
n=5 participants at risk
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 4: L9LS (20 mg/kg IV)
n=4 participants at risk
L9LS (20 mg/kg) administered by IV infusion (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 5: CHMI Controls
n=6 participants at risk
Control participants who did not receive L9LS and were enrolled to complete the controlled human malaria infection (CHMI)
Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum
|
Group 6: L9LS (5 mg/kg IM)
n=5 participants at risk
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
VRC-MALMAB0114-00-AB: VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
16.7%
1/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Investigations
Blood Creatinine Increased
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
40.0%
2/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
40.0%
2/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Pain
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site pain
|
60.0%
3/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
40.0%
2/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site pruritus
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site erythema
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site bruise
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Malaise
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
60.0%
3/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Chills
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
1/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
1/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/4 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/6 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/5 • Unsolicited adverse event (AE) data collection included AEs of all severities for the L9LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Solicited AEs collected through systematic assessment for L9LS recipients only and unsolicited AEs collected for L9LS and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
Additional Information
VRC Clinical Trials Program Leadership
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place