Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00317473
• Date of registration: 20/04/2006
• Primary sponsor: U.S. Army Office of the Surgeon General
• Public title: Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
• Scientific 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.
• Date of first enrolment: August 2003
• Target sample size: 135
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00317473
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Countries of recruitment

Kenya

Contacts

• Name: Mark R. Withers, M.D., MPH
• Affiliation: USAMRU-K

Key inclusion & exclusion 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.



Age minimum: 12 Months
Age maximum: 47 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Plasmodium Falciparum Malaria

Intervention(s)

Biological: MSP-1 (FMP-1) with AS02A vs Imovax rabies vaccine

Primary Outcome(s)

Occurrence of serious adverse events during an 8 month follow-up period following the first dose of study vaccine

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)

Secondary Outcome(s)

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

Secondary ID(s)

HSPC No. HS171

HSRRB Log No. A-12094

KEMRI SSC No. 761

WRAIR 1030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Kenya Medical Research Institute

The PATH Malaria Vaccine Initiative (MVI)

United States Agency for International Development (USAID)

Walter Reed Army Institute of Research (WRAIR)