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Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine

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ClinicalTrials.gov Identifier: NCT00223990
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 4, 2013
Sponsor:
Collaborators:
The PATH Malaria Vaccine Initiative (MVI)
United States Agency for International Development (USAID)
GlaxoSmithKline
Kenya Medical Research Institute
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Brief Summary:

This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum.

Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions.

This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination.

One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine.


Condition or disease Intervention/treatment Phase
Malaria, Falciparum Biological: FMP1/AS02A Phase 2

Detailed Description:

Full, Unabbreviated Title:

A Double-blind, Randomized, Controlled, Phase IIb Field Trial in 12 to 47 Month-old Children in Western Kenya to Evaluate the Efficacy, Safety and Immunogenicity of the FMP1/AS02A Malaria Vaccine (WRAIR's MSP-1 Antigen Adjuvanted in GlaxoSmithKline's AS02A) Versus Rabies Vaccine


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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Dbl-blind,Randomized,Controlled,Phase IIb Field Trial in 12-47 Month-old Children in Western Kenya to Eval the Efficacy,Safety and Immunogenicity of the FMP1/AS02A Malaria Vaccine vs Rabies Vaccine
Study Start Date : March 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. To assess the efficacy of the FMP1/AS02A malaria vaccine on clinical episodes of P. falciparum malaria during the Efficacy Follow-up Period (EFP)

Secondary Outcome Measures :
  1. Efficacy
  2. - To assess the efficacy of the FMP1/AS02A malaria vaccine against clinical episodes of P. falciparum malaria of differing severity during the EFP
  3. Safety and Immunogenicity
  4. - To assess solicited adverse events occurring in the seven days following each dose of vaccine
  5. - To assess unsolicited adverse events occurring in the 30 days following each dose of vaccine
  6. - To assess serious adverse events occurring after the first dose of vaccine to the end of the EFP
  7. - To assess the immunogenicity of the FMP1/AS02A malaria vaccine from the first dose of vaccine to the end of the EFP
  8. - To assess the association between MSP-1 antibody titers and the subsequent risk of clinical malaria during the EFP


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

  • A healthy male or female child, 12 to 47 months of age on the day of screening
  • Written informed consent obtained from at least one parent/guardian before study start
  • Available to participate for the study duration (about 14 months)

Exclusion Criteria:

  • Acute disease at the time of entry into the study that in the opinion of the investigator may pose a threat to the subject
  • Prior receipt of a rabies vaccine or any investigational vaccine
  • Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed)
  • Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid
  • Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S/AS02A)
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV test will be performed as part of this study.)
  • History of allergic reactions or anaphylaxis to immunizations or to any vaccine components, such as eggs
  • History of surgical splenectomy
  • Administration of immunoglobulins, blood transfusions, or any other blood products within the six months preceding the first dose of study vaccine or planned administration during the study period
  • Simultaneous participation in any other clinical trial
  • Acute or chronic cardiovascular, pulmonary, hepatic, or renal condition that in the opinion of the PI, may increase the risk to the subject from participating in the study
  • Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223990


Locations
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Kenya
Walter Reed Project
Kombewa Clinic, City of Kisumu, Nyanza Province, Kenya
Sponsors and Collaborators
U.S. Army Medical Research and Development Command
The PATH Malaria Vaccine Initiative (MVI)
United States Agency for International Development (USAID)
GlaxoSmithKline
Kenya Medical Research Institute
Walter Reed Army Institute of Research (WRAIR)
Investigators
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Principal Investigator: Bernhards Ogutu, M.D. Kenya Medical Research Institute

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00223990     History of Changes
Other Study ID Numbers: WRAIR 1123
HSRRB A-13228
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

Keywords provided by U.S. Army Medical Research and Development Command:
Plasmodium
falciparum
malaria
vaccine
AS02A adjuvant
FMP1
Merozoite surface protein-1

Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs