At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 255 enrolled

Drug / intervention

RTS, S/AS01B +2 morebiological

Likely dose

RTS,S/AS01B or RTS,S/AS02A: 0.5 mL dose (50 µg RTS,S antigen) administered intramuscularly at 0, 1, and 2 monthsAI-extracted

Key inclusion· 3

✓Healthy male or female volunteers aged 18–35 years at first vaccination
✓Female volunteers must be non-childbearing potential (surgically sterilized or ≥1 year post-menopausal) OR, if childbearing potential, abstinent or on adequate contraception ≥30 days prior to vaccination, with negative pregnancy test, and continuing contraception for 2 months after vaccination series
✓Written informed consent provided

Key exclusion· 7

✕Any confirmed or suspected immunosuppressive or immunodeficient conditions
✕Family history of congenital or hereditary immunodeficiency
✕History of allergic reactions to previous immunizations
✕HBsAg positive (hepatitis B surface antigen positive)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00197054

NCT00197054Phase 2Completed

Compare CT.gov

A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02A, and RTS,S/AS01B, Two Candidate Malaria Vaccines in Malaria-experienced Adults Living in Western Kenya.

U.S. Army Medical Research and Development Command·interventional·Posted Sep 20, 2005·Updated Feb 12, 2021

In Brief

A Phase 2 clinical trial evaluating RTS, S/AS01B, RTS, S/AS02A, and 1 other intervention for Plasmodium Falciparum. Completed, enrolled 255 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPlasmodium Falciparum

CountriesKenya

CollaboratorsGlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2005

First PostedSep 2005

Primary CompletionSep 2006

TodayJul 2026

First PostedSep 20, 2005

Enrollment StartJul 1, 2005

Primary CompletionSep 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 20.8 years ago

Interventions

RTS, S/AS01Bbiological

0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.

RTS, S/AS02Abiological

0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.

Rabipur (Rabies) Vaccinebiological

1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months