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Completed

NCT Number: NCT01556945

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

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.

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Key information

Conditions

Malaria, Falciparum Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

WRAIR Clinical Trials Center

Silver Spring, Maryland, 20910, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMP1/AS02

Biological

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.

RTS,S/AS02

Biological

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.

AS02 adjuvant alone

Other

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.

Malaria challenge

Other

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.

Primary outcomes

  1. Safety

    Time frame: two years

    Measured through adverse event collection and immunogenicity results

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: MAL019

Important dates

Study start
2001
Primary completion
2002
First posted
Mar 19, 2012
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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