a study on HIV/AIDS
The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults.
A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of 3 Different HIV-1 DNA Priming Regimens (Nat-B Env, CON-S Env, and Mosaic Env) With MVA-CMDR Boosts in Healthy, HIV-1-Uninfected Adults
This study will evaluate the safety, tolerability, and immunogenicity to four different HIV vaccines in healthy, HIV-uninfected adults. The vaccines include three DNA vaccines—DNA Nat-B env, DNA CON-S env, and DNA Mosaic env—and a vaccine called MVA-CMDR that may boost the immune response to the DNA vaccines.
The study will enroll healthy, HIV-uninfected participants aged 18 to 50 years. Participants will be randomly assigned to one of three groups and will receive either one of the experimental vaccine regimens or a placebo vaccine regimen. Group 1 participants will receive the DNA Nat-B env and MVA-CMDR vaccines or placebo. Group 2 participants will receive the DNA CON-S env and MVA-CMDR vaccines or placebo. Group 3 participants will receive DNA Mosaic env and MVA-CMDR vaccines or placebo.
All participants will receive one of their assigned vaccines at study entry (Month 0), and Months 1, 2, 4, and 8.
Total study duration will be either 3 years after enrollment (for participants in the United States) or 5 years after enrollment (for participants in Switzerland). For all participants, study visits will occur at study entry (Month 0), and Months 0.5, 1, 1.5, 2, 2.5, 4, 4.5, 8, 8.25, 8.5, 11, 13.75, and 14. After the last study visit, participants will be contacted annually by phone or e-mail for a total of 3 (U.S. participants) or 5 (Switzerland participants) years to answer questions about their health.
All study visits will include a physical exam, HIV risk reduction counseling, and an interview and/or questionnaire. Select study visits will include blood collection, urine and stool collection, HIV testing, an electrocardiogram (ECG), and a pregnancy test for participants who were born female. For participants receiving the MVA-CMDR vaccine, select study visits may also include an assessment of cardiac symptoms.
HIV Infections Vaccines
Open to people ages 18–50
General and Demographic Criteria
Good general health as shown by medical history, physical exam, and screening laboratory tests
Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
Laboratory Inclusion Values
Hemogram/Complete Blood Count (CBC)
Platelets equal to 125,000 to 550,000/mm^3
Cardiac Troponin T or I (cTnT or cTnI) does not exceed the institutional upper limit of normal
Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick,a microscopic urinalysis with red blood cells levels within institutional normal range)
Pregnant or breastfeeding
Vaccines and Other Injections
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Hypersensitivity to eggs and/or egg products
Clinically Significant Medical Conditions
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