Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

This study has been completed.
Sponsor:
Collaborators:
Kenya Medical Research Institute
Walter Reed Army Institute of Research (WRAIR)
The PATH Malaria Vaccine Initiative (MVI)
United States Agency for International Development (USAID)
GlaxoSmithKline
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00317473
First received: April 20, 2006
Last updated: April 24, 2006
Last verified: April 2006
  Purpose

To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months


Condition Intervention Phase
Plasmodium Falciparum Malaria
Biological: MSP-1 (FMP-1) with AS02A vs Imovax rabies vaccine
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: Double-Blind,Randomized,Controlled,Dose Escalation Phase 1 Trial in 12-47 Month Old Children in Western Kenya to Evaluate the Safety and Immunogenicity of WRAIR’s MSP-1(FMP1) Malaria Vaccine Adjuvanted in GSK's AS02A Versus Rabies Vaccine.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Occurrence of solicited symptoms during a 7 day follow-up period after each vaccination (5 visits: day of vaccination and days 1, 2, 3, and 7)
  • Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
  • Occurrence of serious adverse events during an 8 month follow-up period following the first dose of study vaccine

Secondary Outcome Measures:
  • Antibody responses to MSP-1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine

Estimated Enrollment: 135
Study Start Date: August 2003
Estimated Study Completion Date: September 2004
Detailed Description:

The study evaluates the safety, reactogenicity, and immunogenicity of an investigational malaria vaccine. The design is of an age-stratified phase Ib, double-blind, randomized, controlled, dose-escalation trial. Children were recruited into one of three cohorts (dosage groups) and randomized in 2:1 fashion to receive either the test product or a comparator. The setting is a rural population in Kombewa Division, western Kenya. The participants are 135 children aged 12-47 months and their mothers. The interventions are 10, 25 or 50 g of the falciparum malaria protein 1 (FMP1) formulated in 100, 250 and 500 L respectively of AS02A, or a comparator (Imovax® rabies vaccine). Outcome measures are safety and reactogenicity parameters and assessment of adverse events during solicited periods (7 days) and unsolicited periods (30 days) after each vaccination. Serious adverse events were monitored for 6 months after the last vaccination.

  Eligibility

Ages Eligible for Study:   12 Months to 47 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute disease at the time of entry into the study
  • Axillary temperature of 37.5C
  • Respiratory rate  50
  • Serum ALT  45 IU/l (i.e., > 1.5 X ULN)
  • Decreased renal function: serum creatinine levels > 92.2 mM/l (> 1.1 mg/dl).
  • Significant anemia (Hgb <8 gm/dL).
  • Thrombocytopenia (Platelets < 100,000 per mm3)
  • Impaired immunity: (Absolute lymphocyte count [ALC] for 1 year olds < 4.0 x 103/mm3; for 2 year olds < 3.0 x 103/mm3; for 3 year olds < 2.0 103/mm3.
  • History of homozygous sickle cell disease (SS).
  • Malnutrition (Z score; Malnutrition = Weight for height < - 3 z scores)
  • Blood transfusion or use of blood-based product in previous 6 months.
  • Prior receipt of a rabies vaccine or an investigational malaria 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 cortico-steroids, 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).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV testing will be undertaken as part of this study.)
  • History of allergic reactions or anaphylaxis to immunizations or to any vaccine components.
  • History of surgical splenectomy.
  • Administration of immunoglobulins or any blood products within the 3 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, which 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.
  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: NCT00317473

Locations
Kenya
Walter Reed Project Kombewa Clinic
Kombewa, Nyanza Province, Kenya
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Kenya Medical Research Institute
Walter Reed Army Institute of Research (WRAIR)
The PATH Malaria Vaccine Initiative (MVI)
United States Agency for International Development (USAID)
GlaxoSmithKline
Investigators
Principal Investigator: Mark R. Withers, M.D., MPH USAMRU-K
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00317473     History of Changes
Other Study ID Numbers: WRAIR 1030, HSRRB Log No. A-12094, KEMRI SSC No. 761, HSPC No. HS171
Study First Received: April 20, 2006
Last Updated: April 24, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Vaccine
Phase 1
Plasmodium falciparum
Malaria
Merozoite surface protein-1
MSP-1
Falciparum malaria protein 1
FMP-1
AS02A

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 18, 2014