Trial Outcomes & Findings for Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine (NCT NCT01024686)
NCT ID: NCT01024686
Last Updated: 2019-10-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
From administration of study vaccine through 7 days (± 1 days) post dosing
Results posted on
2019-10-28
Participant Flow
Participant milestones
| Measure |
p52-p36- GAP Vaccine
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
Infectivity Control
Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
0
|
|
Overall Study
COMPLETED
|
6
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine
Baseline characteristics by cohort
| Measure |
p52-p36- GAP Vaccine
n=6 Participants
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
Infectivity Control
Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito.
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From administration of study vaccine through 7 days (± 1 days) post dosingPopulation: (0) Zero participants analyzed because the study was terminated prior to enrollment.
Outcome measures
| Measure |
p52-p36- GAP Vaccine
n=6 Participants
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito
|
Infectivity Control
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
|
|---|---|---|---|
|
Occurrence of Solicited Adverse Events (AE)
|
52 events
|
—
|
—
|
PRIMARY outcome
Timeframe: From administration of study vaccine through 28 days (± 4 days) post dosingPopulation: (0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge.
Outcome measures
| Measure |
p52-p36- GAP Vaccine
n=6 Participants
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito
|
Infectivity Control
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
|
|---|---|---|---|
|
Occurrence of Unsolicited AEs
|
13 events
|
—
|
—
|
PRIMARY outcome
Timeframe: From administration of study vaccine through 7 days (± 1 days) post dosingPopulation: (0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge
Volunteers with any laboratory abnormality.
Outcome measures
| Measure |
p52-p36- GAP Vaccine
n=6 Participants
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito
|
Infectivity Control
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
|
|---|---|---|---|
|
Occurrence of Laboratory Adverse Events (AE)
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From 7 days after administration of vaccine through 28 days (+ 4 days) post-dosingPopulation: (0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge.
Outcome measures
| Measure |
p52-p36- GAP Vaccine
n=6 Participants
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito
|
Infectivity Control
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
|
|---|---|---|---|
|
Detection of Breakthrough Peripheral Parasitemia by Thick Blood Film
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline through 28 daysPopulation: (0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge.
Outcome measures
| Measure |
p52-p36- GAP Vaccine
n=6 Participants
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito
|
Infectivity Control
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
|
|---|---|---|---|
|
Occurrence of Serious Adverse Events (SAE)
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From administration of study vaccine through the duration of the trialPopulation: (0) Participants because clinical study was terminated before enrollment for primary malaria challenge
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From administration of study vaccine through the duration of the trialPopulation: (0) Participants because clinical study was terminated before enrollment for primary malaria challenge.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From administration of study vaccine through the duration of the trialPopulation: (0) data available because the clinical trial was terminated before DAY 90 blood draw for P. falciparum specific cell-mediated immune responses.
Outcome measures
Outcome data not reported
Adverse Events
p52-p36- GAP Vaccine
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Infectivity Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
p52-p36- GAP Vaccine + Infectivity Challenge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
p52-p36- GAP Vaccine
n=6 participants at risk
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
Infectivity Control
Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
|---|---|---|---|
|
Infections and infestations
Peripheral parasitemia
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
Other adverse events
| Measure |
p52-p36- GAP Vaccine
n=6 participants at risk
p52-/p36- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.
p52-p36- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
Infectivity Control
Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
p52-p36- GAP Vaccine + Infectivity Challenge
p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
|
|---|---|---|---|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 10
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Arthralgia
|
50.0%
3/6 • Number of events 4
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Diarrhea
|
16.7%
1/6 • Number of events 3
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Malaise
|
33.3%
2/6 • Number of events 6
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Myalgia
|
50.0%
3/6 • Number of events 7
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Nausea/vomiting
|
66.7%
4/6 • Number of events 13
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Headache
|
100.0%
6/6 • Number of events 27
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Edema
|
83.3%
5/6 • Number of events 8
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
6/6 • Number of events 19
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Induration
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Pain
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Puritus
|
100.0%
6/6 • Number of events 18
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Ear and labyrinth disorders
Hypoacusis
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Ear and labyrinth disorders
Otitis externa
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Application site papules
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Feeling cold
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Feeling hot
|
33.3%
2/6 • Number of events 3
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Injection site discoloration
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Injection site erythema
|
33.3%
2/6 • Number of events 2
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
General disorders
Vaccination site pruritus
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Immune system disorders
Seasonal Allergy
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Number of events 2
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 6
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Nervous system disorders
Insomnia
|
16.7%
1/6 • Number of events 2
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Nervous system disorders
Photophobia
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 2
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Rash papuar
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Skin and subcutaneous tissue disorders
Scab
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Investigations
Haemoglobin decreased
|
33.3%
2/6 • Number of events 2
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
|
Injury, poisoning and procedural complications
Confusion
|
16.7%
1/6 • Number of events 1
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
—
0/0
This clinical study was withdrawn before enrollment of participants for arm 2 and arm 3. Therefore, no participants were at risk for adverse events from these arms.
|
Additional Information
Dr. Michele Spring
U.S. Military Malaria Vaccine Program (USMMVP)
Phone: 301-319-9307
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place