Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S

NCT01556945 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-05-02

No results posted yet for this study

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.

Conditions

Malaria, Falciparum

Interventions

BIOLOGICAL

FMP1/AS02

The vaccine antigen FMP1 consists of a recombinant histidine-tagged (His6) fusion protein expressed in E. coli. The lyophilized pellet contained per vaccine vial 62.5 μg merozoite surface protein-142 (MSP-142) with 3.1% lactose as cryoprotectant in each 3 ml monodose vial. The pellet was reconstituted with AS02.

BIOLOGICAL

RTS,S/AS02

The vaccine antigen RTS,S, is a recombinant subunit vaccine produced in, and purified from yeast cells. The final lyophilized pellet contained 62.5 μg RTS,S with 3.15% lactose as cryoprotectant per 3 ml monodose vial. The pellet was reconstituted in AS02 and each 0.5 ml dose contained 50 μg RTS,S.

OTHER

AS02 adjuvant alone

AS02 adjuvant contains 50 μg monophosphoryl lipid A (MPL) and 50 μg Quillaja saponaria 21 (QS-21), 250 μl of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 ml.

OTHER

Malaria challenge

Experimental challenge homologous strain of P.falciparum sporozoites. Mosquitoes infected with malaria approximately 17 to 19 days earlier and that contained sporozoites in their salivary glands. For each volunteer, five mosquitoes were allowed to feed over five minutes, after which they were dissected to confirm how many were infected, and the salivary glands scored.

Sponsors & Collaborators

GlaxoSmithKline
collaborator INDUSTRY
U.S. Army Medical Research and Development Command
lead FED

Study Design

Allocation: RANDOMIZED
Purpose: PREVENTION
Masking: DOUBLE
Model: FACTORIAL

Eligibility

Min Age: 18 Years
Max Age: 45 Years
Sex: ALL
Healthy Volunteers: Yes

Timeline & Regulatory

Start: 2001-04-30
Primary Completion: 2002-02-28

Countries

United States

Study Locations

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Entities

Companies

GlaxoSmithKline