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:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2012
Last Updated Date	March 16, 2012
Start Date ^ICMJE	April 2001
Primary Completion Date	February 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 16, 2012)	Safety [ Time Frame: two years ] [ Designated as safety issue: Yes ] Measured through adverse event collection and immunogenicity results
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01556945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Malaria, Falciparum
Intervention ^ICMJE	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.
Study Arm (s)	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 Intervention: Biological: RTS,S, FMP1 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 Intervention: Biological: RTS,S, FMP1
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	Not Provided
Primary Completion Date	February 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01556945
Other Study ID Numbers ^ICMJE	WRAIR #849
Has Data Monitoring Committee	No
Responsible Party	Walter Reed Army Institute of Research (WRAIR) ( U.S. Army Office of the Surgeon General )
Study Sponsor ^ICMJE	U.S. Army Office of the Surgeon General
Collaborators ^ICMJE	GlaxoSmithKline
Investigators ^ICMJE	Not Provided
Information Provided By	Walter Reed Army Institute of Research (WRAIR)
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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