Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S
Phase 1
Completed
- Conditions
- Malaria, Falciparum
- Interventions
- Biological: FMP1/AS02Biological: RTS,S/AS02Other: AS02 adjuvant aloneOther: Malaria challenge
- Registration Number
- NCT01556945
- Lead Sponsor
- U.S. Army Medical Research and Development Command
- Brief Summary
The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection.
The RTS,S vaccine contains a malaria protein in combination with a portion of the commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd vaccination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Healthy adult, 18-45
- Available for duration of study (9 months)
- Written informed consent prior to any study procedures
Exclusion Criteria
- Prior receipt of an investigational malaria vaccine or one containing MPL or QS-21
- Use of any investigational or non-registered drug/vaccine or planned administration of vaccine not foreseen by study protocol; each issue within 30 days preceding the first dose of study vaccine
- Administration of chronic immunosuppressants
- Chronic use of antibiotics
- History of malaria ever, or use of malaria chemoprophylaxis within 60 days prior to vaccination
- Known exposure to malaria within the past 12 months or planned travel to malarious area during the study period
- Confirmed or suspected immunosuppressive or immunodeficient condition
- Family history of congenital or hereditary immunodeficiency
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Chronic or active neurologic disease including seizures
- History of splenectomy
- Seropositive for hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV), or other abnormal labs such as significant anemia, elevated creatinine
- Hepatomegaly, or right upper quadrant abdominal pain
- Pregnant or lactating female
- Chronic or active drug or alcohol use
- History of severe reactions to mosquito bites
- Any history of anaphylaxis to vaccinations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Group A : FMP1/AS02 + RTS,S/AS02 FMP1/AS02 FMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group A : FMP1/AS02 + RTS,S/AS02 RTS,S/AS02 FMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group A : FMP1/AS02 + RTS,S/AS02 Malaria challenge FMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group B : FMP1/AS02 + RTS,S/AS02 FMP1/AS02 FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group B : FMP1/AS02 + RTS,S/AS02 RTS,S/AS02 FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group B : FMP1/AS02 + RTS,S/AS02 Malaria challenge FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group C: FMP1/AS02 + AS02 FMP1/AS02 FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group C: FMP1/AS02 + AS02 AS02 adjuvant alone FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group C: FMP1/AS02 + AS02 Malaria challenge FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group D : RTS,S/AS02 + AS02 RTS,S/AS02 RTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group D : RTS,S/AS02 + AS02 AS02 adjuvant alone RTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Group D : RTS,S/AS02 + AS02 Malaria challenge RTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Control cohort Malaria challenge Infectivity controls (unvaccinated). Non-randomized infectivity controls were recruited specifically for the malaria challenge phase of the trial.
- Primary Outcome Measures
Name Time Method Safety two years Measured through adverse event collection and immunogenicity results
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
WRAIR Clinical Trials Center
🇺🇸Silver Spring, Maryland, United States