Status:
COMPLETED
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
GlaxoSmithKline
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Plasmodium Falciparum
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief Summary
The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As ...
Detailed Description
The study comprises of 3 groups and the participating subjects will be randomly allocated to one of the three groups. The first group will receive RTS,S/AS01B, the second group will receive RTS,S/AS02...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female volunteers aged between 18 and 35 years at the time of first vaccination who have given written consent for their participation in the study were included
- If the volunteer is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
- Exclusion criteria:
- If a subject plans to take vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded
- Volunteers with any confirmed or suspected immunosuppressive or immunodeficient conditions
- Family history of congenital or hereditary immunodeficiency
- History of allergic reactions to previous immunizations
- HBsAg positive subjects
- History of splenectomy
- Pregnant or lactating females will be excluded from the study
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00197054
Start Date
July 1 2005
End Date
September 1 2006
Last Update
February 12 2021
Active Locations (1)
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1
U.S. Army Research Unit-Kenya
Kisumu, Kenya