HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria: HIV uninfected Has access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study Willing to receive HIV test results Good general health Willing to use acceptable forms of contraception Completed at least 12 years of schooling (South African participants only) Exclusion Criteria: HIV vaccines in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Current tuberculosis prophylaxis or therapy Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol. Any job-related responsibility that would interfere with the study Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Active syphilis infection Unstable asthma Diabetes mellitus type 1 or 2 Thyroid disease requiring treatment Serious angioedema within the past 3 years Uncontrolled hypertension Bleeding disorder Cancer. If a participant has had surgery to remove the cancer and, in the opinion of the investigator, the cancer is not likely to recur during the study period, the participant is not excluded. Seizure disorder Asplenia Mental illness that would interfere with compliance with the protocol Other conditions that, in the judgment of the investigator, would interfere with the study Pregnant or breastfeeding
Sites / Locations
- Alabama Vaccine CRS
- Project Brave HIV Vaccine CRS
- Brigham and Women's Hosp. CRS
- Miriam Hospital's HVTU
- Vanderbilt Vaccine CRS
- Projeto Praca Onze/Hesfa Crs
- Sao Paulo HVTU - CRT DST/AIDS CRS
- Les Centres GHESKIO CRS
- Epidemiology Research & Training Unit Jamaica MOH CRS
- Soweto HVTN CRS
- Emavundleni Desmond Tutu HIV Centre CRS
- CAPRISA Aurum CRS
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
DNA HIV vaccine administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine administered at Month 6
DNA HIV vaccine placebo administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine placebo administered at Month 6