Phase 3
Completed N=200
Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children
Source: ClinicalTrials.gov NCT01148459 ↗Enrolled (actual)
200
Serious AEs
39.0%
Results posted
Jan 2019
Primary outcomePrimary: Number of Subjects With Serious Adverse Events (SAEs) — 41; 37; 41; 37 Participants
◆ Published Evidence
Established
34citations · ~3 / year
Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease: a randomised, double-blind, controlled trial.
Summary
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children
Linked Publications
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Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease: a randomised, double-blind, controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
41; 37; 41; 37 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
19; 7; 0; 0; 6; 3 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
9; 3; 3; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
98; 100 | — |
| SECONDARY Number of Subjects With Non-malaria Related SAEs |
41; 37 | — |
| SECONDARY Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations |
0.3; 0.3; 329.2; 0.3 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers |
24.1; 19.2; 13637.6; 19.9 | — |
| SECONDARY Anti-CS Antibody Concentrations |
18.4; 0.3 | — |
| SECONDARY Anti-HBs Antibody Titers |
2294.8; 11.8 | — |
| SECONDARY Number of Episodes With Clinical Malaria Disease According to Primary Case Definition |
44; 76 | — |
| SECONDARY Number of Episodes With Severe Malaria According to Primary Case Definition |
0; 0; 0; 6 | — |
| SECONDARY Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia |
7; 3; 5; 4 | — |
| SECONDARY Asexual P. Falciparum Parasitemia Density |
7; 3 | — |
| SECONDARY Prevalent Hemoglobin Level |
10.3; 10.1 | — |
| SECONDARY HIV Viral Load |
149000.00; 157000.00; 3125.00; 583.50; 3790.00; 400.00 | — |
| SECONDARY Percentage of CD4+ Cells |
27.55; 26.52; 29.70; 29.92; 32.70; 31.07 | — |
| SECONDARY CD4+ Absolute Cell Counts |
2075.91; 2086.46; 2150.99; 2173.04; 2261.71; 2044.51 | — |
| SECONDARY World Health Organization (WHO) HIV Clinical Classification Progression |
81; 82; 18; 19; 0; 0 | — |
| SECONDARY Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score |
-1.67; -1.98; -1.38; -1.67; -0.65; -0.90 | — |
Eligibility Criteria
Inclusion 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.
- 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.
Exclusion Criteria
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01148459) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.