Trial Outcomes & Findings for Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults (NCT NCT01157897)
NCT ID: NCT01157897
Last Updated: 2019-05-29
Results Overview
Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
7 days after immunization
Results posted on
2019-05-29
Participant Flow
41 patients were enrolled (30 vaccination group, 6 infectivity control group and 5 alternates) and received treatment at the Clinical Trials Center (CTC) at Walter Reed Army Institute of Research (WRAIR)
Participant milestones
| Measure |
Cohort 1: 15 μg VMP001
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GlaxoSmithKline (GSK) Biologicals' Adjuvant System AS01B (Adjuvant Formulation)
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
6
|
|
Overall Study
COMPLETED
|
8
|
8
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: 15 μg VMP001
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GlaxoSmithKline (GSK) Biologicals' Adjuvant System AS01B (Adjuvant Formulation)
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
1
|
|
Overall Study
Relocated
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults
Baseline characteristics by cohort
| Measure |
Cohort 1: 15 μg VMP001
n=10 Participants
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
n=10 Participants
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
n=10 Participants
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
n=6 Participants
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
28.7 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
30.1 years
STANDARD_DEVIATION 8.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
6 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 days after immunizationPopulation: Control group was not included in the evaluation.
Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.
Outcome measures
| Measure |
Cohort 1: 15 μg VMP001
n=10 Participants
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
n=10 Participants
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
n=10 Participants
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Local: Injection site erythema
|
2 participants with AEs
|
3 participants with AEs
|
6 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Local: Injection site induration
|
0 participants with AEs
|
1 participants with AEs
|
2 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Local: Injection site pain
|
10 participants with AEs
|
10 participants with AEs
|
10 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Diarrhea
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Nausea
|
5 participants with AEs
|
3 participants with AEs
|
4 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Vomiting
|
2 participants with AEs
|
0 participants with AEs
|
2 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Fatigue
|
8 participants with AEs
|
4 participants with AEs
|
7 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Pyrexia
|
4 participants with AEs
|
2 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Arthralgia
|
4 participants with AEs
|
2 participants with AEs
|
3 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Myalgia
|
4 participants with AEs
|
4 participants with AEs
|
7 participants with AEs
|
—
|
|
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Solicited Systemic: Headache
|
8 participants with AEs
|
6 participants with AEs
|
5 participants with AEs
|
—
|
PRIMARY outcome
Timeframe: 28 days following immunizationPopulation: Control group was not included in this evaluation.
Adverse events were evaluated over a 28 day follow-up period after each vaccination during the vaccine phase
Outcome measures
| Measure |
Cohort 1: 15 μg VMP001
n=10 Participants
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
n=10 Participants
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
n=10 Participants
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Platelet count decreased
|
0 participants with AEs
|
1 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Hypertension
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Ear discomfort
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Abdominal discomfort
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Abdominal pain
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Feces discolored
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Food poisoning
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Nausea
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Toothache
|
2 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Axillary pain
|
0 participants with AEs
|
1 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Chills
|
5 participants with AEs
|
5 participants with AEs
|
7 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Feeling hot
|
5 participants with AEs
|
6 participants with AEs
|
7 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Injection site erythema
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Injection site pruritus
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Injection site swelling
|
0 participants with AEs
|
2 participants with AEs
|
3 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Injection site warmth
|
0 participants with AEs
|
1 participants with AEs
|
2 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Malaise
|
3 participants with AEs
|
5 participants with AEs
|
7 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Hypertransaminasaemia
|
1 participants with AEs
|
2 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Seasonal allergy
|
1 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Nasopharyngitis
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Upper respiratory tract infection
|
2 participants with AEs
|
0 participants with AEs
|
2 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Contusion
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Excoriation
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Postprocedural discomfort
|
0 participants with AEs
|
1 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Posttraumatic pain
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Scratch
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Skin laceration
|
0 participants with AEs
|
0 participants with AEs
|
2 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Haemoglobin decreased
|
0 participants with AEs
|
1 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Gout
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Back pain
|
0 participants with AEs
|
1 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Muscle spasms
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Musculoskeletal discomfort
|
1 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Myalgia
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Pain in extremity
|
2 participants with AEs
|
0 participants with AEs
|
2 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Dizziness
|
1 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Headache
|
1 participants with AEs
|
0 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Sinus headache
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Nasal Congestion
|
0 participants with AEs
|
0 participants with AEs
|
1 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Cold sweat
|
2 participants with AEs
|
4 participants with AEs
|
2 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Dermatitis contact
|
0 participants with AEs
|
1 participants with AEs
|
0 participants with AEs
|
—
|
|
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Erythema
|
0 participants with AEs
|
1 participants with AEs
|
0 participants with AEs
|
—
|
PRIMARY outcome
Timeframe: up to 463 daysOccurrence of serious adverse events at any time during the approximately 463 day study period
Outcome measures
| Measure |
Cohort 1: 15 μg VMP001
n=10 Participants
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
n=10 Participants
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
n=10 Participants
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
n=6 Participants
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)
Not Related to study drug - Breast cancer (left)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)
Related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)
Patients without SAE
|
9 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 280 day (during the study through 6 months aftr challenge)Population: Drop-outs prior to vaccination were not included in the analysis
Subjects were ranked according to time of onset of parasitemia and a non-parametric rankorder statistical test (eg, Log-Rank or Mann-Whitney) was performed to evaluate delays in parasitemia induced by vaccination. Cox Proportional Hazards model was used to calculate days to parasitemia and Kaplan-Meier plots were used to display time to first positive malaria blood smear. Hazard Ratio (HR). Time starts once subject has received t infectious bites. Time stops when subject has first positive blood smear. If subject does not become parasitemic then time stops the day he/she begins anti-malarial therapy.
Outcome measures
| Measure |
Cohort 1: 15 μg VMP001
n=9 Participants
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
n=8 Participants
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
n=10 Participants
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Time to Parasitemia for Immunogenicity Population
|
0.137 days
Standard Error 2.025
|
0.073 days
Standard Error 2.106
|
0.042 days
Standard Error 2.154
|
—
|
SECONDARY outcome
Timeframe: study durationPopulation: Immunogenicity population
Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '\>50' were converted to '1'.
Outcome measures
| Measure |
Cohort 1: 15 μg VMP001
n=10 Participants
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
n=10 Participants
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
n=10 Participants
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
Pre-vaccination
|
1 Geometric Mean Titer of European Units
Interval 1.0 to 1.0
|
1.5 Geometric Mean Titer of European Units
Interval 0.6 to 3.76
|
3.09 Geometric Mean Titer of European Units
Interval 0.56 to 17.05
|
—
|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
2wks post first vaccination
|
151.39 Geometric Mean Titer of European Units
Interval 31.62 to 724.71
|
526.18 Geometric Mean Titer of European Units
Interval 194.01 to 1427.06
|
836.68 Geometric Mean Titer of European Units
Interval 147.84 to 4735.05
|
—
|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
Day of second vaccination
|
281.79 Geometric Mean Titer of European Units
Interval 53.6 to 1481.36
|
1175.41 Geometric Mean Titer of European Units
Interval 391.29 to 3530.89
|
1711.63 Geometric Mean Titer of European Units
Interval 685.48 to 4273.89
|
—
|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
2wks post second vaccination
|
21862.22 Geometric Mean Titer of European Units
Interval 10775.91 to 44354.18
|
74608.62 Geometric Mean Titer of European Units
Interval 51309.78 to 108487.04
|
61711.8 Geometric Mean Titer of European Units
Interval 33584.06 to 113397.42
|
—
|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
Day of third vaccination
|
9921.61 Geometric Mean Titer of European Units
Interval 5707.48 to 17247.25
|
28498.43 Geometric Mean Titer of European Units
Interval 18863.52 to 43054.55
|
36405.66 Geometric Mean Titer of European Units
Interval 19839.55 to 66804.57
|
—
|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
2wks post third vaccination
|
59883.77 Geometric Mean Titer of European Units
Interval 38915.79 to 92149.38
|
68730.4 Geometric Mean Titer of European Units
Interval 48391.1 to 97618.54
|
41879.99 Geometric Mean Titer of European Units
Interval 22137.62 to 79228.66
|
—
|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
4wks post challenge
|
54843.38 Geometric Mean Titer of European Units
Interval 34557.05 to 87038.59
|
56472.17 Geometric Mean Titer of European Units
Interval 38216.28 to 83448.88
|
32178.39 Geometric Mean Titer of European Units
Interval 17659.05 to 58635.6
|
—
|
|
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
6months post challenge
|
10860.7 Geometric Mean Titer of European Units
Interval 5151.41 to 22897.6
|
12519.16 Geometric Mean Titer of European Units
Interval 5950.55 to 26338.62
|
5500.73 Geometric Mean Titer of European Units
Interval 2751.67 to 10996.23
|
—
|
SECONDARY outcome
Timeframe: study durationPopulation: Efficacy population
Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '\>50' were converted to '1'.
Outcome measures
| Measure |
Cohort 1: 15 μg VMP001
n=9 Participants
15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 2: 30 μg VMP001
n=8 Participants
30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Cohort 3: 60 μg VMP001
n=10 Participants
60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.
VMP001: Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
Control
No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.
P. vivax sporozoite challenge: P. vivax sporozoite challenge
|
|---|---|---|---|---|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
2wks post first vaccination
|
133.72 Geometric Mean Titier of European Units
Interval 23.1 to 774.0
|
750.38 Geometric Mean Titier of European Units
Interval 251.51 to 2238.74
|
836.68 Geometric Mean Titier of European Units
Interval 147.84 to 4735.05
|
—
|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
Pre-vaccination
|
1 Geometric Mean Titier of European Units
Interval 1.0 to 1.0
|
1 Geometric Mean Titier of European Units
Interval 1.0 to 1.0
|
3.09 Geometric Mean Titier of European Units
Interval 0.56 to 17.05
|
—
|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
Day of second vaccination
|
244.35 Geometric Mean Titier of European Units
Interval 38.22 to 1562.29
|
1450.22 Geometric Mean Titier of European Units
Interval 460.04 to 4571.68
|
1711.63 Geometric Mean Titier of European Units
Interval 685.48 to 4273.89
|
—
|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
2wks post second vaccination
|
20161.18 Geometric Mean Titier of European Units
Interval 9253.42 to 43926.79
|
81143.72 Geometric Mean Titier of European Units
Interval 55905.91 to 117774.72
|
61711.8 Geometric Mean Titier of European Units
Interval 33584.06 to 113397.42
|
—
|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
Day of third vaccination
|
9053.32 Geometric Mean Titier of European Units
Interval 5047.3 to 16238.9
|
31071.01 Geometric Mean Titier of European Units
Interval 20413.38 to 47292.88
|
36405.66 Geometric Mean Titier of European Units
Interval 19839.55 to 66804.57
|
—
|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
2wks post third vaccination
|
61203.48 Geometric Mean Titier of European Units
Interval 37570.19 to 99703.16
|
68730.4 Geometric Mean Titier of European Units
Interval 48391.1 to 97618.54
|
41879.99 Geometric Mean Titier of European Units
Interval 22137.62 to 79228.66
|
—
|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
4wks post challenge
|
54843.38 Geometric Mean Titier of European Units
Interval 34557.05 to 87038.59
|
56472.17 Geometric Mean Titier of European Units
Interval 38216.28 to 83448.88
|
32178.39 Geometric Mean Titier of European Units
Interval 17659.05 to 58635.6
|
—
|
|
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
6mths post challenge
|
10860.7 Geometric Mean Titier of European Units
Interval 5151.41 to 22897.6
|
12519.16 Geometric Mean Titier of European Units
Interval 5950.55 to 26338.62
|
5500.73 Geometric Mean Titier of European Units
Interval 2751.67 to 10996.23
|
—
|
Adverse Events
Cohort 1: 15 μg VMP001
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2: 30 μg VMP001
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3: 60 μg VMP001
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4: Control
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 15 μg VMP001
n=9 participants at risk
01
|
Cohort 2: 30 μg VMP001
n=8 participants at risk
02
|
Cohort 3: 60 μg VMP001
n=10 participants at risk
03
|
Cohort 4: Control
n=6 participants at risk
04
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Cohort 1: 15 μg VMP001
n=9 participants at risk
01
|
Cohort 2: 30 μg VMP001
n=8 participants at risk
02
|
Cohort 3: 60 μg VMP001
n=10 participants at risk
03
|
Cohort 4: Control
n=6 participants at risk
04
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
3/9 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
70.0%
7/10 • Number of events 9
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
20.0%
2/10 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Number of events 5
|
75.0%
6/8 • Number of events 7
|
90.0%
9/10 • Number of events 10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1
|
37.5%
3/8 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Adverse drug reaction
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Chills
|
44.4%
4/9 • Number of events 5
|
75.0%
6/8 • Number of events 7
|
70.0%
7/10 • Number of events 7
|
0.00%
0/6
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 6
|
75.0%
6/8 • Number of events 6
|
100.0%
10/10 • Number of events 11
|
83.3%
5/6 • Number of events 9
|
|
General disorders
Feeling hot
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
66.7%
4/6 • Number of events 4
|
|
General disorders
Influenza like illness
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
55.6%
5/9 • Number of events 7
|
75.0%
6/8 • Number of events 6
|
50.0%
5/10 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
22.2%
2/9 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Clostridium difficile colitis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Influenza
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
2/9 • Number of events 2
|
37.5%
3/8 • Number of events 3
|
30.0%
3/10 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Infections and infestations
Viral infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Incision site pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/9
|
25.0%
2/8 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.4%
4/9 • Number of events 4
|
62.5%
5/8 • Number of events 5
|
50.0%
5/10 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
44.4%
4/9 • Number of events 5
|
50.0%
4/8 • Number of events 5
|
90.0%
9/10 • Number of events 9
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
55.6%
5/9 • Number of events 7
|
62.5%
5/8 • Number of events 7
|
80.0%
8/10 • Number of events 9
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 2
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
30.0%
3/10 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
40.0%
4/10 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 4
|
25.0%
2/8 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
33.3%
3/9 • Number of events 3
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Nervous system disorders
Tension headache
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9
|
25.0%
2/8 • Number of events 2
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
11.1%
1/9 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
22.2%
2/9 • Number of events 3
|
37.5%
3/8 • Number of events 3
|
40.0%
4/10 • Number of events 5
|
16.7%
1/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/9
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place