NCT00317473

Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 12 Months – 47 Months
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
BIOLOGICAL	FMP1/AS02A Malaria vaccine	Subjects vaccinated with FMP1/AS02 vaccine
BIOLOGICAL	Imovax Rabies vaccine	Subjects vaccinated on corresponding FMP1/AS02A vaccination days

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-07-01
• Completion: 2005-07-01
• First posted: 2006-04-24
• Last updated: 2017-10-02
• Results posted: 2017-10-02

Locations

1 site across 1 country: Kenya