Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali

This study has been completed.
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
United States Agency for International Development (USAID)
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00308061
First received: March 24, 2006
Last updated: December 1, 2006
Last verified: October 2006
  Purpose

This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and measured the ability of the vaccine to stimulate antibodies directed against the malaria protein that the vaccine is based on. Forty adults were randomly assigned to get either the experimental malaria vaccine or a rabies vaccine, for comparison.


Condition Intervention Phase
Malaria
Biological: FMP1/AS02A
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Dbl Blind Randomized Controlled Phase I Trial to Eval the Safety and Immunogenicity of WRAIR’s MSP1 Candidate Malaria Vaccine (FMP1) Adjuvant in GSK Bio's AS02A vs. Rabies Vaccine in Semi-Immune Adults in Bandiagara, Mali.

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Safety
  • Reactogenicity

Secondary Outcome Measures:
  • Antibody response to the vaccine

Estimated Enrollment: 40
Study Start Date: July 2003
Estimated Study Completion Date: July 2004
Detailed Description:

The study was a randomized, controlled trial in which participants and clinical investigators were blinded to vaccine group assignment. Forty adults were randomized in a 1:1 ratio to receive either FMP1/AS02A or the control rabies vaccine. The aims of the control group were to account for baseline morbidity and the impact of seasonal malaria transmission on the dynamics of anti-MSP-1 antibodies, and to minimize bias in assessment of adverse events. Vaccines were given on a 0-, 1- and 2-month schedule. The first immunization was given in early July just as malaria transmission began; the second dose at the end of July as transmission was increasing; and the third dose in late August near the peak of malaria transmission intensity. Study day 90 was in October, shortly after transmission crests and when severe and uncomplicated malaria disease episodes peak, study day 180 was at the end of the malaria season, and study day 272 was at the height of the dry season. The final study follow-up on day 364 coincided with the beginning of the 2004 malaria season. Interim safety analyses were reviewed by an independent Safety Monitoring Committee before the second and third immunizations.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or non-pregnant female aged 18-55 years inclusive at the time of screening.
  • For women, willingness not to become pregnant until 1 month after the last dose of vaccine
  • Written informed screening and study consent obtained from the participant before study start.
  • Available and willing to participate in follow-up for the duration of study (12 months)

Exclusion Criteria:

  • Previous vaccination with an investigational malaria vaccine or with any rabies vaccine.
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
  • Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose. This will include oral steroids and inhaled steroids, but not topical steroids.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine(s) with the exception of tetanus toxoid.
  • Previous vaccination with a vaccine containing MPL and/or QS-21 such as RTS,S.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Any confirmed or suspected autoimmune disease
  • History of allergic reactions or anaphylaxis to immunizations or to any vaccine component.
  • History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
  • History of allergy to tetracycline, doxycycline or neomycin
  • History of splenectomy
  • Serum ALT >=35 IU/L
  • Serum creatinine level >133 micro moles per Liter (1.5 mg/dL)
  • Hb <11 g/dL for males and <10 g/dL for females
  • WBC <3.0 x 103/mm3 or >13.5 x 103/mm3
  • Absolute lymphocyte count <=1.0 x 103 per micro liter
  • Thrombocytopenia < 100,000 per micro liter
  • More than trace protein, more than trace hemoglobin or positive glucose in urine
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Suspected or known current alcohol or illicit drug abuse.
  • Pregnancy or positive urine beta-HCG on the day of or prior to immunization.
  • Breastfeeding
  • Simultaneous participation in any other interventional clinical trial.
  • Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition, or any other findings that in the opinion of the PI may increase the risk to the participant from participating in the study.
  • Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308061

Locations
Mali
Bandiagara Malaria Project
Bandiagara, Mali
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Mahamadou A Thera, MD MPH University of Bamako Faculty of Medicine, Mali
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00308061     History of Changes
Other Study ID Numbers: WRAIR 1029, NIH DMID 02-184, Univ of Maryland IRB 0303311, HSRRB A-12093, NIAID IRB 177
Study First Received: March 24, 2006
Last Updated: December 1, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Plasmodium falciparum
malaria
merozoite surface protein-1

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 29, 2014