Trial Outcomes & Findings for Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali (NCT NCT03989102)
NCT ID: NCT03989102
Last Updated: 2024-03-19
Results Overview
Assess safety and tolerability of PfSPZ Vaccine primary series in healthy Malian women of child-bearing potential (WOCBP) when given at 1, 8, 29 days at two doses (9 x10\^5; 1.8 x10\^6).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
324 participants
Primary outcome timeframe
7 days after each vaccination at days 1, 8, and 29
Results posted on
2024-03-19
Participant Flow
324 participants were enrolled, but 24 participants were not assigned to any treatment arms due to withdrawn consent; thus 300 total participants were assigned to treatment arms.
Participant milestones
| Measure |
Arm 1: 9x10^5 Dose
Participants received 3 doses of PfSPZ Vaccine (9 x10\^5) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 2: 1.8 x 10^6 Dose
Participants received 3 doses of PfSPZ Vaccine (1.8 x10\^6) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 3: Placebo Comparator
Participants received 3 doses of saline injection via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
|---|---|---|---|
|
Year 1
STARTED
|
100
|
100
|
100
|
|
Year 1
COMPLETED
|
88
|
96
|
87
|
|
Year 1
NOT COMPLETED
|
12
|
4
|
13
|
|
Year 2
STARTED
|
85
|
92
|
84
|
|
Year 2
COMPLETED
|
66
|
78
|
68
|
|
Year 2
NOT COMPLETED
|
19
|
14
|
16
|
|
Post-Year 3 (up to 3 Years, 8 Months)
STARTED
|
68
|
79
|
71
|
|
Post-Year 3 (up to 3 Years, 8 Months)
COMPLETED
|
63
|
72
|
67
|
|
Post-Year 3 (up to 3 Years, 8 Months)
NOT COMPLETED
|
5
|
7
|
4
|
Reasons for withdrawal
| Measure |
Arm 1: 9x10^5 Dose
Participants received 3 doses of PfSPZ Vaccine (9 x10\^5) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 2: 1.8 x 10^6 Dose
Participants received 3 doses of PfSPZ Vaccine (1.8 x10\^6) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 3: Placebo Comparator
Participants received 3 doses of saline injection via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
|---|---|---|---|
|
Year 1
Withdrawal by Subject
|
6
|
2
|
7
|
|
Year 1
Lost to Follow-up
|
5
|
2
|
5
|
|
Year 1
Subject met withdrawal criteria
|
1
|
0
|
1
|
|
Year 2
Lost to Follow-up
|
7
|
3
|
4
|
|
Year 2
Withdrawal by Subject
|
3
|
1
|
2
|
|
Year 2
Subject non-compliant
|
3
|
2
|
0
|
|
Year 2
Travel
|
1
|
0
|
1
|
|
Year 2
P16 missing
|
4
|
2
|
1
|
|
Year 2
P11 missing
|
1
|
3
|
7
|
|
Year 2
Definitive displacement outside the study site
|
0
|
1
|
0
|
|
Year 2
Subject missed last study visit
|
0
|
1
|
0
|
|
Year 2
Death
|
0
|
1
|
0
|
|
Year 2
Subject not reachable
|
0
|
0
|
1
|
|
Post-Year 3 (up to 3 Years, 8 Months)
Lost to Follow-up
|
1
|
2
|
2
|
|
Post-Year 3 (up to 3 Years, 8 Months)
Withdrawal by Subject
|
1
|
1
|
1
|
|
Post-Year 3 (up to 3 Years, 8 Months)
Widowhood
|
1
|
0
|
0
|
|
Post-Year 3 (up to 3 Years, 8 Months)
Missed last study visit
|
2
|
1
|
0
|
|
Post-Year 3 (up to 3 Years, 8 Months)
Travel
|
0
|
3
|
0
|
|
Post-Year 3 (up to 3 Years, 8 Months)
Relocated
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1
n=100 Participants
Participants received 3 doses of PfSPZ Vaccine (9 x10\^5) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 2
n=100 Participants
Participants received 3 doses of PfSPZ Vaccine (1.8 x10\^6) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 3
n=100 Participants
Participants received 3 doses of saline injection via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Mossi
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
2 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Wolof
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Mianka
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
1 Participants
n=300 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=300 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
300 Participants
n=300 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=300 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
300 Participants
n=300 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=300 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Race/Ethnicity, Customized
Bambara
|
72 Participants
n=100 Participants
|
76 Participants
n=100 Participants
|
74 Participants
n=100 Participants
|
222 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Dogon
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Kakolo
|
2 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
3 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Koroko
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Malinke
|
4 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
3 Participants
n=100 Participants
|
11 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Peulh
|
7 Participants
n=100 Participants
|
7 Participants
n=100 Participants
|
10 Participants
n=100 Participants
|
24 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Sarakole
|
8 Participants
n=100 Participants
|
5 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
17 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Senoufo
|
1 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Soninke
|
3 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
6 Participants
n=100 Participants
|
10 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Sonrhai
|
1 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Bobo
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
2 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Gana
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=300 Participants
|
|
Region of Enrollment
Mali
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
300 Participants
n=300 Participants
|
PRIMARY outcome
Timeframe: 7 days after each vaccination at days 1, 8, and 29Assess safety and tolerability of PfSPZ Vaccine primary series in healthy Malian women of child-bearing potential (WOCBP) when given at 1, 8, 29 days at two doses (9 x10\^5; 1.8 x10\^6).
Outcome measures
| Measure |
Arm 1
n=100 Participants
Participants received 3 doses of PfSPZ Vaccine (9 x10\^5) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 2
n=100 Participants
Participants received 3 doses of PfSPZ Vaccine (1.8 x10\^6) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 3
n=100 Participants
Participants received 3 doses of saline injection via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
|---|---|---|---|
|
Number of Participants With Adverse Events Within 7 Days After Each Vaccine Administration
|
51 Participants
|
43 Participants
|
43 Participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 43 other events
Deaths: 1 deaths
Arm 3
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=100 participants at risk
Participants received 3 doses of PfSPZ Vaccine (9 x10\^5) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 2
n=100 participants at risk
Participants received 3 doses of PfSPZ Vaccine (1.8 x10\^6) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
Arm 3
n=100 participants at risk
Participants received 3 doses of saline injection via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
3.0%
3/100 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Asthenia
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
4.0%
4/100 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Investigations
Blood creatinine increased
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Chills
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
4/100 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Fatigue
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Nervous system disorders
Headache
|
28.0%
28/100 • Number of events 35 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
25.0%
25/100 • Number of events 27 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
26.0%
26/100 • Number of events 31 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Investigations
Hemoglobin decreased
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Injection site erythema
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Injection site edema
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Injection site pain
|
7.0%
7/100 • Number of events 9 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
6.0%
6/100 • Number of events 6 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
8.0%
8/100 • Number of events 9 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Injection site pruritus
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
4/100 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
3.0%
3/100 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
3.0%
3/100 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Investigations
Neutrophil count decreased
|
4.0%
4/100 • Number of events 5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
5.0%
5/100 • Number of events 5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Pain
|
2.0%
2/100 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Skin and subcutaneous tissue disorders
Pruritus (localized)
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Skin and subcutaneous tissue disorders
Pruritis (generalized)
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
General disorders
Pyrexia
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Gastrointestinal disorders
Vessel puncture site erythema
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Investigations
White blood cell count decreased
|
4.0%
4/100 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
5.0%
5/100 • Number of events 6 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
3.0%
3/100 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
|
Investigations
White blood cell count increased
|
0.00%
0/100 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
2.0%
2/100 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
1.0%
1/100 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
|
Additional Information
Patrick E. Duffy
Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301.761.5089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place