Phase 2
N=255
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Plasmodium Falciparum
Bottom Line
View on ClinicalTrials.gov: NCT00197054 ↗Enrolled (actual)
255
Serious AEs
4.3%
Results posted
Dec 2020
Primary outcome: Primary: Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B — 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RTS, S/AS01B (Biological); RTS, S/AS02A (Biological); Rabipur (Rabies) Vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B |
0; 1 | — |
| PRIMARY Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms |
3; 0; 1; 1; 0; 0 | — |
| PRIMARY Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period |
132; 166; 68; 12; 22; 2 | — |
| SECONDARY Safety: Occurrence of SAEs |
1.2; 0.0; 0.0; 0.0; 0.0; 1.2 | — |
| SECONDARY Safety: Occurrence of SAEs |
1.2; 0.0; 0.0; 0.0; 0.0; 1.2 | — |
| SECONDARY Occurrence of Hematology Parameters Below Normal Range |
0; 0; 0; 4; 1; 1 | — |
| SECONDARY Occurrence of Biochemistry Parameters Above Normal Ranges |
10; 9; 11; 6; 4; 7 | — |
Summary
The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.
Eligibility Criteria
Inclusion criteria
- Healthy male or female volunteers aged between 18 and 35 years at the time of first vaccination who have given written consent for their participation in the study were included
- If the volunteer is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
Exclusion criteria
- If a subject plans to take vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded
- Volunteers with any confirmed or suspected immunosuppressive or immunodeficient conditions
- Family history of congenital or hereditary immunodeficiency
- History of allergic reactions to previous immunizations
- HBsAg positive subjects
- History of splenectomy
- Pregnant or lactating females will be excluded from the study
Data sourced from ClinicalTrials.gov (NCT00197054). 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.