Clinical Trial for Malaria Vaccines to Test for Safety, Immune Response and Protection Against Malaria
NCT00870987 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2021-02-11
Summary
The purpose of this study is to test the safety and effectiveness of a new malaria vaccine, the DNA-Ad vaccine. The study is specifically looking at a vaccine regimen against Plasmodium falciparum, the most deadly form of malaria.
Conditions
Interventions
- BIOLOGICAL
-
DNA vaccine prime
2 mg total dose (1 mg per construct in a volume of 1 mL)
- BIOLOGICAL
-
adenovirus type 5 vaccine boost
2 x 1010 particle units (pu) (1 x 1010 pu per each of 2 constructs including CSP and AMA1 respectively)
Sponsors & Collaborators
-
United States Agency for International Development (USAID)
collaborator FED -
Walter Reed Army Institute of Research (WRAIR)
collaborator FED -
U.S. Army Medical Research and Development Command
lead FED
Principal Investigators
-
Judith Epstein, MD · US Military Vaccine Program, NMRC PI, Naval Officer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2014-04-30
- Completion
- 2015-07-31
Countries
- United States
Study Locations
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