Safety and immunogenicity of GSK Biologicals’ investigational malaria vaccine in HIV infected infants and childrenN/A
Trial overview
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from 30 days before Dose 1 up to Month 14)
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: During the 30-day post-vaccination period (up to Day 90)
Number of subjects with non-malaria related SAEs
Timeframe: During the entire study period (from 30 days before vaccine Dose 1 up to Month 14)
Anti-circumsporozoite protein of P. falciparum (anti-CS) antibody concentrations
Timeframe: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)
Anti-hepatitis B surface antigen (anti-HBs) antibody titers
Timeframe: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)
Anti-CS antibody concentrations
Timeframe: 12 months post Dose 3 (Month 14)
Anti-HBs antibody titers
Timeframe: 12 months post Dose 3 (Month 14)
Number of episodes with clinical malaria disease according to primary case definition
Timeframe: From Day 0 to Month 14
Number of episodes with severe malaria according to primary case definition
Timeframe: From Day 0 to Month 14
Number of subjects affected by prevalent parasitemia and prevalent moderate anemia
Timeframe: 12 months post Dose 3 (Month 14)
Asexual P. falciparum parasitemia density
Timeframe: 12 months post Dose 3 (Month 14)
Prevalent hemoglobin level
Timeframe: 12 months post Dose 3 (Month 14)
HIV viral load
Timeframe: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
Percentage of CD4+ cells
Timeframe: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
CD4+ absolute cell counts
Timeframe: At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
World Health Organization (WHO) HIV clinical classification progression
Timeframe: At baseline (PRE), at study months 1 (Month 1) and 2 (Month 2) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
Growth parameters: weight, age/length and middle upper arm circumference for age z-score
Timeframe: At baseline (PRE), at Month 3 and at study end (Month 14)
Participation criteria
- All subjects must satisfy ALL the following criteria at study entry:
- A male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination.
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Acute disease at the time of enrolment. However, the presence of an illness listed as Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself constitute an exclusion criterion. Enrolment should be deferred if axillary temperature is >=37.5°C.
- A male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination.
- Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the infant or child. Where parents/LARs are illiterate, the consent form will be countersigned by a witness.
- Subjects who the investigator believes that their parents/LARs can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects who are known to be HIV-infected (documented positive DNA PCR), whether taking HIV antiretroviral treatment (ART) or not.
- Subjects who are born following a normal gestation period.
All subjects must satisfy ALL the following criteria at study entry:
- Acute disease at the time of enrolment. However, the presence of an illness listed as Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself constitute an exclusion criterion. Enrolment should be deferred if axillary temperature is >=37.5°C.
- Grade III or Grade IV abnormality on screening laboratory blood sample.
- Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging).
- Major congenital defects.
- Planned administration/administration of a vaccine not foreseen by the study protocol prior to or within 7 days of study vaccine.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding Dose°1 of study vaccine, or planned use during the study period.
- Previous participation in any other malaria vaccine trial.
- Simultaneous participation in another clinical trial including administration of experimental treatment.
- Same sex twins.
- History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- Child in care.
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.