Clinical trial NCT01556945: Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S
Official title: Phase I/IIa Safety, Immunogenicity, and Preliminary Efficacy of an Administration Schedule of FMP1 and SmithKlineBeecham Biologicals' Candidate Malaria Vaccine RTS,S Each Adjuvanted With SBAS2, Given Concomitantly in Separate Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malaria, Falciparum
Keywords: P. falciparum
vaccine
healthy volunteers
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
First posted: 2012-03-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: WRAIR Clinical Trials Center
state: Maryland
Study officials:
References: