Trial Outcomes & Findings for VAC069: A Study of Blood-stage Controlled Human P. Vivax Infection (NCT NCT03797989)
NCT ID: NCT03797989
Last Updated: 2025-04-25
Results Overview
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
19 participants
Primary outcome timeframe
36 months
Results posted on
2025-04-25
Participant Flow
Participant milestones
| Measure |
Phase A: Group 1
Each volunteer will receive one vial of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 2
Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 3
Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase B: Group 4
The six volunteers from Groups 1, 2 and 3 in will undergo secondary challenge using the optimal inoculum, as determined in Phase A of the study. They will constitute 'Group 4' in Phase B. This will occur approximately eight months (and up to nine months) later after their primary challenge.
|
Phase B: Group 6
Three new malaria naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls to Group 4.
|
Phase C: Group 5
The six volunteers from Group 4 in Phase B will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 5 in Phase C. This will occur approximately sixteen months (and up to twenty months) later after their secondary challenge.
|
Phase C: Group 7
The three volunteers from Group 6 who underwent primary challenge in Phase B undergo secondary challenge, again using the optimal inoculum as determined in Phase A, and will now form Group 7 in Phase C. This will occur approximately six months (and up to nine months) later after their primary challenge.
|
Phase C: Group 9
Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 5 and 7.
|
Phase D: Group 8
The three volunteers from Group 7 in Phase C will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 8 in Phase D. This will occur approximately five months (and up to ten months) after their secondary challenge.
|
Phase D: Group 10
The four to eight volunteers from Group 9 in Phase C will undergo secondary challenge, using the optimal inoculum as determined in Phase A, and form Group 10 in Phase D. This will occur approximately six months (and up to nine months) later after their primary challenge.
|
Phase D: Group 12
Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 8 and 10.
|
Phase E: Group 13
Volunteers from Groups 10 and 12 who completed at least one P. vivax CHMI in Phase D will be re-enrolled into Group 13 to undergo repeat heterlogous CHMI with P. falciparum in Phase E. This will occur occur approximately 12 months after their last P. vivax challenge.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
VAC069A
STARTED
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069A
COMPLETED
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069A
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069B
STARTED
|
0
|
0
|
0
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069B
COMPLETED
|
0
|
0
|
0
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069C
STARTED
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
7
|
0
|
0
|
0
|
0
|
|
VAC069C
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
7
|
0
|
0
|
0
|
0
|
|
VAC069C
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069D
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
7
|
4
|
0
|
|
VAC069D
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
7
|
4
|
0
|
|
VAC069D
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VAC069E
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
VAC069E
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
VAC069E
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase A: Group 1
Each volunteer will receive one vial of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 2
Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 3
Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase B: Group 4
The six volunteers from Groups 1, 2 and 3 in will undergo secondary challenge using the optimal inoculum, as determined in Phase A of the study. They will constitute 'Group 4' in Phase B. This will occur approximately eight months (and up to nine months) later after their primary challenge.
|
Phase B: Group 6
Three new malaria naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls to Group 4.
|
Phase C: Group 5
The six volunteers from Group 4 in Phase B will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 5 in Phase C. This will occur approximately sixteen months (and up to twenty months) later after their secondary challenge.
|
Phase C: Group 7
The three volunteers from Group 6 who underwent primary challenge in Phase B undergo secondary challenge, again using the optimal inoculum as determined in Phase A, and will now form Group 7 in Phase C. This will occur approximately six months (and up to nine months) later after their primary challenge.
|
Phase C: Group 9
Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 5 and 7.
|
Phase D: Group 8
The three volunteers from Group 7 in Phase C will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 8 in Phase D. This will occur approximately five months (and up to ten months) after their secondary challenge.
|
Phase D: Group 10
The four to eight volunteers from Group 9 in Phase C will undergo secondary challenge, using the optimal inoculum as determined in Phase A, and form Group 10 in Phase D. This will occur approximately six months (and up to nine months) later after their primary challenge.
|
Phase D: Group 12
Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 8 and 10.
|
Phase E: Group 13
Volunteers from Groups 10 and 12 who completed at least one P. vivax CHMI in Phase D will be re-enrolled into Group 13 to undergo repeat heterlogous CHMI with P. falciparum in Phase E. This will occur occur approximately 12 months after their last P. vivax challenge.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
VAC069A
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
VAC069: A Study of Blood-stage Controlled Human P. Vivax Infection
Baseline characteristics by cohort
| Measure |
Phase A: Group 1
n=2 Participants
Each volunteer will receive one vial of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 2
n=2 Participants
Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 3
n=2 Participants
Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase B: Group 6
n=2 Participants
Three new malaria naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls to Group 4.
|
Phase C: Group 9
n=7 Participants
Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 5 and 7.
|
Phase D: Group 12
n=4 Participants
Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 8 and 10.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
25.5 years
n=7 Participants
|
22.5 years
n=5 Participants
|
26 years
n=4 Participants
|
27 years
n=21 Participants
|
25.5 years
n=8 Participants
|
26 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Arab
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Mixed - White and Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
4 participants
n=8 Participants
|
19 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Number of SAEs occuring during study period
Outcome measures
| Measure |
Primary P. Vivax CHMI
n=19 Participants
Malaria naive volunteers who underwent primary controlled human malaria infection (CHMI) with blood-stage P. vivax during phases VAC069A to VAC069D of the study.
|
Phase A: Group 2
Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 3
Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All 6 volunteers who underwent primary CHMI during phase VAC069A of the study developed malaria infection and reached diagnostic criteria. An inoculation dose of 1:10 dilution of 1 vial of inoculum per volunteer was chosen for subsequent phases of the study VAC069B to VAC069D.
Choosing the optimal inoculation dose to take forward to future P. vivax CHMI studies will be decided based on the following algorithm: Ideal choice = the first group (2/2 volunteers) to reach diagnosis criteria (within 21 days). N.B. If both volunteers in Group 1 develop infection AND both volunteers in Group 2 (or 3) reliably develop infection within 5 days of Group 1 (and within the 21-day window) then the lowest dose group should be chosen.
Outcome measures
| Measure |
Primary P. Vivax CHMI
n=2 Participants
Malaria naive volunteers who underwent primary controlled human malaria infection (CHMI) with blood-stage P. vivax during phases VAC069A to VAC069D of the study.
|
Phase A: Group 2
n=2 Participants
Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 3
n=2 Participants
Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
|---|---|---|---|
|
Number of Participants Who Developed Infection/Reached Diagnosis Criteria, Used to Select the Optimal Inoculation Dose to Take Forward to Future P. Vivax CHMI Studies Based on a Protocol-specified Algorithm
|
2 Participants who developed infection
|
2 Participants who developed infection
|
2 Participants who developed infection
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: All volunteers undergoing primary controlled human malaria infection with P. vivax (PvW1 clone)
Number of participants developing detectablable parasitaemia during primary CHMI with P. vivax (PvW1 clone)
Outcome measures
| Measure |
Primary P. Vivax CHMI
n=19 Participants
Malaria naive volunteers who underwent primary controlled human malaria infection (CHMI) with blood-stage P. vivax during phases VAC069A to VAC069D of the study.
|
Phase A: Group 2
Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 3
Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
|---|---|---|---|
|
Feasibility of Primary P. Vivax Blood-stage CHMI as Measured by Successful Infection (Development of Detectable Persistent Parasitaemia by Thick Film and qPCR +/- Clinical Symptoms)
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Number of SAEs occuring during study period
Outcome measures
| Measure |
Primary P. Vivax CHMI
n=12 Participants
Malaria naive volunteers who underwent primary controlled human malaria infection (CHMI) with blood-stage P. vivax during phases VAC069A to VAC069D of the study.
|
Phase A: Group 2
n=2 Participants
Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
Phase A: Group 3
n=6 Participants
Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI.
|
|---|---|---|---|
|
Safety of Secondary and Tertiary P. Vivax Controlled Blood-stage CHMI as Measured by (S)AE Occurrences
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 36 monthsAs measured by antibody, B cell and T cell responses through experimental injection of P. vivax infected erythrocytes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsAs measured by qPCR in primary, secondary and tertiary P. vivax blood-stage CHMI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
Outcome data not reported
Adverse Events
Primary P. Vivax CHMI
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Secondary P. Vivax CHMI
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tertiary P. Vivax CHMI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VAC069E - P. Falciparum CHMI
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary P. Vivax CHMI
n=19 participants at risk
Malaria naive volunteers who underwent primary controlled human malaria infection (CHMI) with blood-stage P. vivax during phases VAC069A to VAC069D of the study.
|
Secondary P. Vivax CHMI
n=12 participants at risk
Volunteers who completed one P. vivax CHMI in the preceding phase of the study, underwent secondary CHMI with P. vivax during phases VAC069B to VAC069D of the study.
|
Tertiary P. Vivax CHMI
n=2 participants at risk
Volunteers who completed their second P. vivax CHMI in the preceding phase of the study, underwent tertiary CHMI with P. vivax during phases VAC069C and VAC069D of the study.
|
VAC069E - P. Falciparum CHMI
n=6 participants at risk
Volunteers who completed primary or secondary P. vivax CHMI in phase VAC069D, underwent repeat heterlogous CHMI with P. falciparum in VAC069E.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Upper limb fracture
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
Other adverse events
| Measure |
Primary P. Vivax CHMI
n=19 participants at risk
Malaria naive volunteers who underwent primary controlled human malaria infection (CHMI) with blood-stage P. vivax during phases VAC069A to VAC069D of the study.
|
Secondary P. Vivax CHMI
n=12 participants at risk
Volunteers who completed one P. vivax CHMI in the preceding phase of the study, underwent secondary CHMI with P. vivax during phases VAC069B to VAC069D of the study.
|
Tertiary P. Vivax CHMI
n=2 participants at risk
Volunteers who completed their second P. vivax CHMI in the preceding phase of the study, underwent tertiary CHMI with P. vivax during phases VAC069C and VAC069D of the study.
|
VAC069E - P. Falciparum CHMI
n=6 participants at risk
Volunteers who completed primary or secondary P. vivax CHMI in phase VAC069D, underwent repeat heterlogous CHMI with P. falciparum in VAC069E.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Gastrointestinal disorders
Tooth infection
|
0.00%
0/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
8.3%
1/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
50.0%
1/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
8.3%
1/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.8%
3/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Psychiatric disorders
Stress
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
16.7%
1/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/19 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/12 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
0.00%
0/2 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
16.7%
1/6 • Adverse events were collected from day of malaria challenge (CHMI) until 3 months after each challenge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place