A Phase I Randomized, Controlled, Dosage-Escalation Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Healthy Adults 18 to 45 Years of Age
Malaria is caused by a parasite carried by a mosquito. Currently, there is no vaccine licensed to prevent malaria. The purpose of this study is to find the most effective and safest dose of an experimental vaccine for the treatment of malaria. Participants will include 72 healthy adults, ages18 to 45, enrolled at Vanderbilt University Medical Center and Stanford University. Volunteers will receive 3 doses of either the malaria vaccine or placebo (contains no vaccine) by injection into a muscle at 0, 1 and 6 months. Investigators will evaluate how the body responds to increasing dosage strengths of the vaccine. Study procedures include physical exam, multiple blood draws, and completion of a memory aid (diary). Each participant will be actively involved in the study for about 12 months. Then, an annual phone call will be made to check for any serious illness events for a period of 5 years.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : Ad35.CS.01 Circumsporozoite Malaria Vaccine
- drug : Placebo
Phase: Phase 1
Ages Eligible For Study:
- Provision of informed consent before any protocol procedures are performed. - Males and non-pregnant females between the ages of 18 and 45 years, inclusive. - Females and males must agree to practice adequate contraception until at least 28 days following their last immunization dose (including abstinence; hormonal contraception; condoms with spermicidal agents; post-menopausal; or surgical sterilization/vasectomy). - Participants must agree to avoid high risk sexual behavior for exposure to human immunodeficiency virus (HIV). - In good health as determined by screening medical history, physical examination (PE), and laboratory assessments. - Willingness to comply with protocol requirements. - Willingness to be contacted annually for five years for assessment of serious adverse events. - Must have access to a cell phone.