Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S (MAL019)
This study has been completed.
Sponsor:
U.S. Army Office of the Surgeon General
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Walter Reed Army Institute of Research (WRAIR) ( U.S. Army Office of the Surgeon General )
ClinicalTrials.gov Identifier:
NCT01556945
First received: March 14, 2012
Last updated: March 16, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria, Falciparum |
Biological: RTS,S, FMP1 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Walter Reed Army Institute of Research (WRAIR):
Primary Outcome Measures:
- Safety [ Time Frame: two years ] [ Designated as safety issue: Yes ]Measured through adverse event collection and immunogenicity results
| Enrollment: | 72 |
| Study Start Date: | April 2001 |
| Primary Completion Date: | February 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RTS,S
Malaria vaccine given with the adjuvant SBAS2 together with a second experimental malaria vaccine FMP1 or with an additional dose of the SBAS2 adjuvant at 0, 1 and 2 months from study day 0
|
Biological: RTS,S, FMP1
Each vaccine is combined with an experimental adjuvant, SBAS2 and either given together or with an additional dose of adjuvant SBAS2 at 0, 1, 2 months from study day 0. Each arm received the same combination at each vaccination timepoint.
|
|
Experimental: FMP1
FMP1 malaria vaccine given with adjuvant SBAS2 either with RTS,S or additional adjuvant at 0, 1 and 2 months from study day 0
|
Biological: RTS,S, FMP1
Each vaccine is combined with an experimental adjuvant, SBAS2 and either given together or with an additional dose of adjuvant SBAS2 at 0, 1, 2 months from study day 0. Each arm received the same combination at each vaccination timepoint.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Walter Reed Army Institute of Research (WRAIR) ( U.S. Army Office of the Surgeon General ) |
| ClinicalTrials.gov Identifier: | NCT01556945 History of Changes |
| Other Study ID Numbers: | WRAIR #849 |
| Study First Received: | March 14, 2012 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Walter Reed Army Institute of Research (WRAIR):
|
P. falciparum vaccine healthy volunteers |
Additional relevant MeSH terms:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013