Trial Outcomes & Findings for Safety and Immunogenicity of the Malaria Vaccine, R21/MatrixM, in Healthy Thai Adults (NCT NCT05252845)
NCT ID: NCT05252845
Last Updated: 2025-07-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
From the date of the first vaccination to 28 days after the last vaccination (up to approximately 1 month)
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
R21/Matrix-M + DHA-PIP+PQ
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M Only
The R21/Matrix-M vaccine (IM injection) only
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
|
DHA-PIP+PQ Only
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
22
|
|
Overall Study
COMPLETED
|
48
|
48
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
R21/Matrix-M + DHA-PIP+PQ
n=52 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M Only
n=53 Participants
The R21/Matrix-M vaccine (IM injection) only
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
|
DHA-PIP+PQ Only
n=22 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
the heart rate-corrected QT (QTc) interval
|
416 Millisecond
n=52 Participants
|
415.5 Millisecond
n=53 Participants
|
416 Millisecond
n=22 Participants
|
416 Millisecond
n=127 Participants
|
|
Hemoglobin (Hb)
|
13.5 g/dL
STANDARD_DEVIATION 3.9 • n=52 Participants
|
12.9 g/dL
STANDARD_DEVIATION 1.2 • n=53 Participants
|
12.7 g/dL
STANDARD_DEVIATION 1.1 • n=22 Participants
|
13.1 g/dL
STANDARD_DEVIATION 2.6 • n=127 Participants
|
|
White Blood Cell (WBC)
|
6.4 10^3 cells/Microliter
n=52 Participants
|
7.1 10^3 cells/Microliter
n=53 Participants
|
6.7 10^3 cells/Microliter
n=22 Participants
|
6.5 10^3 cells/Microliter
n=127 Participants
|
|
Creatinine
|
0.7 mg/dL
n=52 Participants
|
0.7 mg/dL
n=53 Participants
|
0.7 mg/dL
n=22 Participants
|
0.7 mg/dL
n=127 Participants
|
|
Platelets
|
281.5 10^6 cells/Microliter
n=52 Participants
|
271 10^6 cells/Microliter
n=53 Participants
|
262.5 10^6 cells/Microliter
n=22 Participants
|
277 10^6 cells/Microliter
n=127 Participants
|
|
Age, Continuous
|
40.5 years
n=52 Participants
|
40 years
n=53 Participants
|
40.5 years
n=22 Participants
|
40 years
n=127 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=52 Participants
|
38 Participants
n=53 Participants
|
17 Participants
n=22 Participants
|
88 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=52 Participants
|
15 Participants
n=53 Participants
|
5 Participants
n=22 Participants
|
39 Participants
n=127 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
64.3 Kg.
n=52 Participants
|
60.7 Kg.
n=53 Participants
|
64 Kg.
n=22 Participants
|
63.1 Kg.
n=127 Participants
|
|
Aspartate Aminotransferase (AST)
|
20.5 U/L
n=52 Participants
|
17.5 U/L
n=53 Participants
|
19.5 U/L
n=22 Participants
|
19 U/L
n=127 Participants
|
|
Alanine Aminotransferase (ALT)
|
19 U/L
n=52 Participants
|
15.5 U/L
n=53 Participants
|
14 U/L
n=22 Participants
|
17 U/L
n=127 Participants
|
|
Temperature
|
36.4 ºC
STANDARD_DEVIATION 0.4 • n=52 Participants
|
36.4 ºC
STANDARD_DEVIATION 0.3 • n=53 Participants
|
36.5 ºC
STANDARD_DEVIATION 0.4 • n=22 Participants
|
36.4 ºC
STANDARD_DEVIATION 0.3 • n=127 Participants
|
PRIMARY outcome
Timeframe: From the date of the first vaccination to 28 days after the last vaccination (up to approximately 1 month)Outcome measures
| Measure |
DHA-PIP+PQ Only
n=53 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=52 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=22 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification.
|
6 Participants
|
17 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: During the whole study period, i.e. during a 6-month follow-up period from the receipt of first vaccinationOutcome measures
| Measure |
DHA-PIP+PQ Only
n=53 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=52 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=22 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Occurrence of Serious Adverse Events (SAEs), According to the MedRA Classification.
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 7 days of each vaccination.Outcome measures
| Measure |
DHA-PIP+PQ Only
n=53 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=52 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=22 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Occurrence of Solicited Adverse Event Within 7 Days of Each Vaccination
|
36 Participants
|
37 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at study Month 1Number of Participants with Seroconversions in C-Term
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=49 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=47 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=18 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in C-Term
|
38 Participants
|
41 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at study Month 2Number of Participants with Seroconversions in C-Term
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=48 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=19 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in C-Term
|
48 Participants
|
50 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at study Month 3Number of Participants with Seroconversions in C-Term
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=48 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=49 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=18 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in C-Term
|
48 Participants
|
49 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at study Month 6Number of Participants with Seroconversions in C-Term
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=48 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=48 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=18 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in C-Term
|
48 Participants
|
48 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at study Month 1Number of Participants with Seroconversions in NANP
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=50 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in NANP
|
50 Participants
|
49 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at study Month2Number of Participants with Seroconversions in NANP
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=50 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in NANP
|
49 Participants
|
50 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at study Month 3Number of Participants with Seroconversions in NANP
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=49 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in NANP
|
49 Participants
|
50 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at study Month 6Number of Participants with Seroconversions in NANP
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=48 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=48 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in NANP
|
48 Participants
|
48 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at study Month 1Number of Participants with Seroconversions in R21
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=50 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=47 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in R21
|
50 Participants
|
47 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at study Month 2Number of Participants with Seroconversions in R21
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=50 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in R21
|
49 Participants
|
50 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at study Month 3Number of Participants with Seroconversions in R21
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=49 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in R21
|
49 Participants
|
50 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at study Month 6Number of Participants With Seroconversions in R21
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=48 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=48 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=18 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in R21
|
48 Participants
|
48 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at study Month 1Number of Participants with Seroconversions in HBsAg
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=49 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=49 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in HBsAg
|
21 Participants
|
27 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: at study Month 2Number of Participants with Seroconversions in HBsAg
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=49 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=48 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in HBsAg
|
23 Participants
|
20 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at study Month 3Number of Participants with Seroconversions in HBsAg
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=49 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=49 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in HBsAg
|
37 Participants
|
36 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: at study Month 6Number of Participants with Seroconversions in HBsAg
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=48 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=48 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Number of Participants With Seroconversions in HBsAg
|
26 Participants
|
24 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Study month 0For Arms 1 and 3, Piperaquine levels (Cmax) following the administration of the antimalarials with or without vaccine
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
For Arms 1 and 3, Piperaquine Levels Following the Administration of the Antimalarials With or Without Vaccine
|
177.5 ng/mL
Interval 125.0 to 213.5
|
139 ng/mL
Interval 114.0 to 185.0
|
—
|
SECONDARY outcome
Timeframe: Study month 0For Arms 1 and 3, Piperaquine levels (AUC) following the administration of the antimalarials with or without vaccine
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
For Arms 1 and 3, Piperaquine Levels Following the Administration of the Antimalarials With or Without Vaccine
|
30594.4 ng*h/mL
Interval 21015.2 to 36429.7
|
23151.6 ng*h/mL
Interval 19577.8 to 33561.8
|
—
|
SECONDARY outcome
Timeframe: Study month 1For Arms 1 and 3, Piperaquine levels (Cmax) following the administration of the antimalarials with or without vaccine
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
For Arms 1 and 3, Piperaquine Levels Following the Administration of the Antimalarials With or Without Vaccine
|
188.5 ng/mL
Interval 134.5 to 246.0
|
167.0 ng/mL
Interval 116.0 to 204.0
|
—
|
SECONDARY outcome
Timeframe: Study month 1For Arms 1 and 3, Piperaquine levels (AUC) following the administration of the antimalarials with or without vaccine
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
For Arms 1 and 3, Piperaquine Levels Following the Administration of the Antimalarials With or Without Vaccine
|
30672.1 ng*h/mL
Interval 20366.4 to 38646.6
|
24221.4 ng*h/mL
Interval 16812.2 to 31600.8
|
—
|
SECONDARY outcome
Timeframe: Study month 2For Arms 1 and 3, Piperaquine levels (Cmax) following the administration of the antimalarials with or without vaccine
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
For Arms 1 and 3, Piperaquine Levels Following the Administration of the Antimalarials With or Without Vaccine
|
28055.4 ng/mL
Interval 19286.0 to 42462.6
|
27652 ng/mL
Interval 21772.0 to 38006.9
|
—
|
SECONDARY outcome
Timeframe: Study month 2For Arms 1 and 3, Piperaquine levels (AUC) following the administration of the antimalarials with or without vaccine
Outcome measures
| Measure |
DHA-PIP+PQ Only
n=20 Participants
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M + DHA-PIP+PQ
n=50 Participants
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
DHA-PIP+PQ Only
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
For Arms 1 and 3, Piperaquine Levels Following the Administration of the Antimalarials With or Without Vaccine
|
28055.4 ng*h/mL
Interval 19286.0 to 42462.6
|
27652 ng*h/mL
Interval 21772.0 to 38006.9
|
—
|
Adverse Events
R21/Matrix-M + DHA-PIP+PQ
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
R21/Matrix-M Only
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
DHA-PIP+PQ Only
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R21/Matrix-M + DHA-PIP+PQ
n=52 participants at risk
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M Only
n=53 participants at risk
The R21/Matrix-M vaccine (IM injection) only
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
|
DHA-PIP+PQ Only
n=22 participants at risk
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Community-acquired pneumonia
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Eye disorders
Optic neuritis with neuromyelitis optica (NMO) right eye
|
0.00%
0/52 • 6 months
|
0.00%
0/53 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
R21/Matrix-M + DHA-PIP+PQ
n=52 participants at risk
The R21/Matrix-M vaccine (IM injection) + co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
R21/Matrix-M Only
n=53 participants at risk
The R21/Matrix-M vaccine (IM injection) only
R21/Matrix-M vaccination: R21/Matrix-M is the standard formulation of the vaccine (Once prepared, a standard dose of R21/Matrix-M contains approximately 5 µg of R21 antigen, in 0.5 mL of liquid adjuvant containing 50 µg MatrixM). The reconstituted vaccine will be administered by slow IM injection on Day 0 at Study Months 0, 1 and 2.
|
DHA-PIP+PQ Only
n=22 participants at risk
Co-formulated Dihydroartemisinin/Piperaquine tablets + one single low dose of Primaquine
DHA-PIP: Dihydroartemisinin/piperaquine tablets for adult patients each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. Participants will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1 and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2.
PQ: Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately 0.25 mg/kg will be administered.
|
|---|---|---|---|
|
General disorders
Malaise
|
7.7%
4/52 • Number of events 4 • 6 months
|
5.7%
3/53 • Number of events 3 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Fever
|
26.9%
14/52 • Number of events 16 • 6 months
|
17.0%
9/53 • Number of events 9 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
ALT increased
|
7.7%
4/52 • Number of events 4 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
26.9%
14/52 • Number of events 18 • 6 months
|
5.7%
3/53 • Number of events 4 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
Somnolence
|
1.9%
1/52 • Number of events 3 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/52 • 6 months
|
0.00%
0/53 • 6 months
|
9.1%
2/22 • Number of events 2 • 6 months
|
|
Infections and infestations
Common cold
|
0.00%
0/52 • 6 months
|
3.8%
2/53 • Number of events 2 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
Dizziness
|
3.8%
2/52 • Number of events 2 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
1/52 • Number of events 2 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Reproductive system and breast disorders
Early menstruation
|
1.9%
1/52 • Number of events 2 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Headache
|
34.6%
18/52 • Number of events 33 • 6 months
|
28.3%
15/53 • Number of events 17 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Immune system disorders
Allergic rhinitis
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/52 • 6 months
|
1.9%
1/53 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Community-acquired Pneumonia
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Cough
|
0.00%
0/52 • 6 months
|
0.00%
0/53 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Dysplasia
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Dysuria
|
0.00%
0/52 • 6 months
|
1.9%
1/53 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Eyebrow pain
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/52 • 6 months
|
1.9%
1/53 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Insomnia
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Lack of communication
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Lack of concentration
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Left/right jaw pain
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm, Ovarian
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash at right little finger
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Rhinitis
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Running nose
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sputum
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy nose
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Urticarial rash
|
0.00%
0/52 • 6 months
|
1.9%
1/53 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Anorexia
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
optic neuritis
|
0.00%
0/52 • 6 months
|
0.00%
0/53 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Infections and infestations
Sneeze
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
viral infection
|
0.00%
0/52 • 6 months
|
0.00%
0/53 • 6 months
|
4.5%
1/22 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52 • Number of events 1 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
13/52 • Number of events 21 • 6 months
|
7.5%
4/53 • Number of events 5 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
4/52 • Number of events 6 • 6 months
|
1.9%
1/53 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Fatigue
|
40.4%
21/52 • Number of events 42 • 6 months
|
32.1%
17/53 • Number of events 23 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
34.6%
18/52 • Number of events 26 • 6 months
|
43.4%
23/53 • Number of events 29 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
13.5%
7/52 • Number of events 9 • 6 months
|
13.2%
7/53 • Number of events 12 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Chills
|
19.2%
10/52 • Number of events 11 • 6 months
|
11.3%
6/53 • Number of events 8 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Pain
|
48.1%
25/52 • Number of events 56 • 6 months
|
56.6%
30/53 • Number of events 56 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Redness
|
5.8%
3/52 • Number of events 6 • 6 months
|
9.4%
5/53 • Number of events 7 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Swelling
|
5.8%
3/52 • Number of events 3 • 6 months
|
18.9%
10/53 • Number of events 12 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Bruising
|
7.7%
4/52 • Number of events 4 • 6 months
|
3.8%
2/53 • Number of events 2 • 6 months
|
0.00%
0/22 • 6 months
|
Additional Information
Professor Lorenz von Seidlein
Mahidol-Oxford Tropical Medicine Research Unit (MORU)
Phone: +66-(0)2-3549170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place