We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317473
First Posted: April 24, 2006
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 (Responsible Party):
U.S. Army Medical Research and Materiel Command
  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: FMP1/AS02A Malaria vaccine Biological: Imovax Rabies vaccine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination [ Time Frame: 40 days ]
    Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period

  • Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination [ Time Frame: 90 days ]
    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 [ Time Frame: 8 months ]
    Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine


Secondary Outcome Measures:
  • Anti-FMP1 Antibody Titer Responses [ Time Frame: 364 days ]
    Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine


Enrollment: 135
Study Start Date: June 2003
Study Completion Date: July 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FMP1/AS02A Malaria vaccine 10ug
Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57
Biological: FMP1/AS02A Malaria vaccine
Subjects vaccinated with FMP1/AS02 vaccine
Experimental: FMP1/AS02A Malaria vaccine 25 ug
Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70
Biological: FMP1/AS02A Malaria vaccine
Subjects vaccinated with FMP1/AS02 vaccine
Experimental: FMP1/AS02A Malaria vaccine 50 ug
Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84
Biological: FMP1/AS02A Malaria vaccine
Subjects vaccinated with FMP1/AS02 vaccine
Active Comparator: Imovax Rabies Vaccine
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
Biological: Imovax Rabies vaccine
Subjects vaccinated on corresponding FMP1/AS02A vaccination days

Detailed Description:
Study consists of 3 cohorts (12 to 23 months, 24 to 35 months, and 36 to 47 months). Within each cohort subjects were randomized in a 2:1 ration to receive one of three dose levels of FMP1/AS02A (Cohort A, 10 ug; Cohort B, 25 ug; Cohort C, 50 ug) or Imovax Rabies vaccine. Immunization was staggered among dose cohorts; subjects in Cohort B received their first immunization only after the Local Medical Monitor and Data Safety Monitoring Board reviewed Cohort A safety data for the eight-day follow-up period following their first immunization. The same procedure was followed for the immunization of Cohort C. This will be conducted in western Kenya a the Walter Reed Project Lumbewa Clinic.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
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 degrees 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
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): NCT00317473


Locations
Kenya
Walter Reed Project Kombewa Clinic
Kombewa, Nyanza Province, Kenya
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
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:

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00317473     History of Changes
Other Study ID Numbers: WRAIR 1030
HSRRB Log No. A-12094 ( Other Identifier: IRB )
KEMRI SSC No. 761 ( Other Identifier: Ethics Committee )
HSPC No. HS171 ( Other Identifier )
First Submitted: April 20, 2006
First Posted: April 24, 2006
Results First Submitted: January 24, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Kenya Medical Research Institute; WRAIR; The Path Malaria Vaccine Initiative; United States Agency for International Development; GlaxoSmith Kline

Keywords provided by U.S. Army Medical Research and Materiel Command:
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs