Trial Outcomes & Findings for L9LS MAb in Malian Adults (NCT NCT05816330)
NCT ID: NCT05816330
Last Updated: 2025-04-02
Results Overview
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants.
COMPLETED
PHASE2
490 participants
Within 7 days after administration of intervention
2025-04-02
Participant Flow
490 participants were consented: * 156 participants were screen failure and ineligible * 45 participants served as backup * One participant withdrew consent * 288 participants received intervention
Participant milestones
| Measure |
L9LS 900 mg
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Overall Study
STARTED
|
217
|
71
|
|
Overall Study
COMPLETED
|
213
|
70
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
L9LS 900 mg
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
L9LS MAb in Malian Adults
Baseline characteristics by cohort
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 Participants
Adult participants receive a single dose of Placebo subcutaneously.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-20 years
|
31 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Customized
21-30 years
|
61 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Customized
31-40 years
|
72 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Customized
41-49 years
|
48 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Customized
50-55 years (Male only)
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
217 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Region of Enrollment
Mali
|
217 participants
n=5 Participants
|
71 participants
n=7 Participants
|
288 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after administration of interventionPopulation: All participants who received study intervention.
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants.
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 Participants
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Number of Participants With Local Adverse Events (AEs)
Injection site swelling
|
7 Participants
|
1 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Pain at Injection site
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Tenderness at injection site
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Redness at injection site
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Bruising at injection site
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs)
Pruritus at injection site
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after administration of interventionPopulation: All participants who received study intervention.
Number of participants with local adverse events occurring within 7 days after administration of L9LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants.
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 Participants
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Number of Participants With Systemic Adverse Events (AEs)
Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Malaise
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Muscle aches
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Headache
|
21 Participants
|
4 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Chills
|
0 Participants
|
2 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Nausea
|
2 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs)
Joint pain
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after administration of interventionPopulation: All participants who received study intervention.
The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 Participants
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 1
|
7 Participants
|
1 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Adverse Events (AEs) (by Grade)
Grade 5
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after administration of interventionPopulation: All participants who received study intervention.
The severity of systemic adverse events occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = \> 39.5\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 Participants
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 1
|
11 Participants
|
2 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 2
|
13 Participants
|
4 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Grade 5
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 7 through week 24Population: All participants who received study intervention.
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood smear.
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 Participants
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination for Thick Blood Smear
|
33 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Day 7 through week 24Population: All participants who received study intervention.
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood sample positive for Pf was assessed by real-time polymerase chain reaction (RT-PCR) of blood sample collected from participants from day 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood sample.
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 Participants
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Participants With Plasmodium Falciparum (Pf) Infection Detected by Real-Time Polymerase Chain Reaction (RT-PCR)
|
68 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Measure through week 24Population: Per protocol document, measure apply to participants who received L9LS
Maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, \& 168 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles postdose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Maximum Total Plasma Concentration (Cmax) for L9LS
|
158.07 ug/mL
Standard Deviation 30.41
|
—
|
SECONDARY outcome
Timeframe: Day 7 post administration of drugPopulation: Per protocol document, measure apply to participants who received L9LS.
Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS on day 7 post administration of drug. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in hours) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration.
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (TMax) for L9LS - Hours
|
172.9 Hours
Standard Deviation 30.0
|
—
|
SECONDARY outcome
Timeframe: Measure through week 24Population: Per protocol document, measure apply to participants who received L9LS.
Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, \& 168 after the administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration.
Outcome measures
| Measure |
L9LS 900 mg
n=217 Participants
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (TMax) for L9LS - Days
|
7.20 Days
Standard Deviation 1.25
|
—
|
Adverse Events
L9LS 900 mg
Placebo
Serious adverse events
| Measure |
L9LS 900 mg
n=217 participants at risk
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 participants at risk
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/217 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
Other adverse events
| Measure |
L9LS 900 mg
n=217 participants at risk
Adult participants receive a single dose of L9LS 900 mg subcutaneously.
|
Placebo
n=71 participants at risk
Adult participants receive a single dose of Placebo subcutaneously.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
21/217 • Number of events 21 • Up to 24 weeks from administration of intervention
|
7.0%
5/71 • Number of events 5 • Up to 24 weeks from administration of intervention
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
4/217 • Number of events 4 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Cardiac disorders
Bradycardia
|
1.8%
4/217 • Number of events 4 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Cardiac disorders
Tachycardia
|
1.4%
3/217 • Number of events 3 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/217 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
4/217 • Number of events 4 • Up to 24 weeks from administration of intervention
|
5.6%
4/71 • Number of events 6 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Dental Caries
|
5.1%
11/217 • Number of events 12 • Up to 24 weeks from administration of intervention
|
2.8%
2/71 • Number of events 2 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Diarrhoea
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Food Poisoning
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Gastritis
|
14.7%
32/217 • Number of events 39 • Up to 24 weeks from administration of intervention
|
4.2%
3/71 • Number of events 3 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Nausea
|
2.8%
6/217 • Number of events 6 • Up to 24 weeks from administration of intervention
|
2.8%
2/71 • Number of events 2 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Toothache
|
11.1%
24/217 • Number of events 26 • Up to 24 weeks from administration of intervention
|
4.2%
3/71 • Number of events 3 • Up to 24 weeks from administration of intervention
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
8/217 • Number of events 9 • Up to 24 weeks from administration of intervention
|
7.0%
5/71 • Number of events 5 • Up to 24 weeks from administration of intervention
|
|
General disorders
Asthenia
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
General disorders
Chest Pain
|
0.46%
1/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
General disorders
Chills
|
6.9%
15/217 • Number of events 16 • Up to 24 weeks from administration of intervention
|
7.0%
5/71 • Number of events 5 • Up to 24 weeks from administration of intervention
|
|
General disorders
Injection Site Swelling
|
3.2%
7/217 • Number of events 7 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
General disorders
Pyrexia
|
4.6%
10/217 • Number of events 10 • Up to 24 weeks from administration of intervention
|
2.8%
2/71 • Number of events 2 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Conjunctivitis
|
7.8%
17/217 • Number of events 18 • Up to 24 weeks from administration of intervention
|
8.5%
6/71 • Number of events 6 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Dysentery
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
4.2%
3/71 • Number of events 3 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Furuncle
|
1.8%
4/217 • Number of events 4 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Gastroenteritis
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Genital Infection
|
2.8%
6/217 • Number of events 6 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Genitourinary Tract Infection
|
1.8%
4/217 • Number of events 4 • Up to 24 weeks from administration of intervention
|
2.8%
2/71 • Number of events 2 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Hordeolum
|
0.00%
0/217 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Malaria
|
9.2%
20/217 • Number of events 20 • Up to 24 weeks from administration of intervention
|
32.4%
23/71 • Number of events 26 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Mastitis
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Paronychia
|
1.4%
3/217 • Number of events 3 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Pharyngitis
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
4.2%
3/71 • Number of events 3 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Rhinitis
|
19.4%
42/217 • Number of events 49 • Up to 24 weeks from administration of intervention
|
23.9%
17/71 • Number of events 24 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Salmonellosis
|
1.4%
3/217 • Number of events 3 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Tinea Infection
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Tinea Pedis
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
17.1%
37/217 • Number of events 39 • Up to 24 weeks from administration of intervention
|
19.7%
14/71 • Number of events 14 • Up to 24 weeks from administration of intervention
|
|
Infections and infestations
Urinary Tract Infection
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/217 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Injury, poisoning and procedural complications
Wound
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/217 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Investigations
Blood Creatinine Increased
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Investigations
Blood Pressure Diastolic Decreased
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Investigations
Blood Pressure Diastolic Increased
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Investigations
Blood Pressure Increased
|
0.46%
1/217 • Number of events 3 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Investigations
Blood Pressure Systolic Increased
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Investigations
Haemoglobin Decreased
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
10/217 • Number of events 10 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.3%
5/217 • Number of events 7 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Nervous system disorders
Dizziness
|
2.8%
6/217 • Number of events 6 • Up to 24 weeks from administration of intervention
|
5.6%
4/71 • Number of events 4 • Up to 24 weeks from administration of intervention
|
|
Nervous system disorders
Headache
|
51.6%
112/217 • Number of events 167 • Up to 24 weeks from administration of intervention
|
33.8%
24/71 • Number of events 38 • Up to 24 weeks from administration of intervention
|
|
Nervous system disorders
Neuralgia
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Nervous system disorders
Paraesthesia
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Nervous system disorders
Syncope
|
0.00%
0/217 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Renal and urinary disorders
Dysuria
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
1.4%
1/71 • Number of events 1 • Up to 24 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.4%
27/217 • Number of events 31 • Up to 24 weeks from administration of intervention
|
11.3%
8/71 • Number of events 10 • Up to 24 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.46%
1/217 • Number of events 1 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
|
Surgical and medical procedures
Tooth Extraction
|
0.92%
2/217 • Number of events 2 • Up to 24 weeks from administration of intervention
|
0.00%
0/71 • Up to 24 weeks from administration of intervention
|
Additional Information
Dr. Peter D Crompton
National Institute of Allergy and Infectious Diseases (NIAID)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place