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
Completed · Phase 2 · Has a placebo group
Conditions studied: HIV Infections
In brief
The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.
Key facts
- Study ID
- NCT00125970
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 480
- Starts
- 2005-09-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2021-10-15
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Alabama Vaccine CRS — Birmingham, Alabama, United States
- Project Brave HIV Vaccine CRS — Baltimore, Maryland, United States
- Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
- Miriam Hospital's HVTU — Providence, Rhode Island, United States
- Vanderbilt Vaccine CRS — Nashville, Tennessee, United States
- Projeto Praca Onze/Hesfa Crs — Rio de Janeiro, Brazil
- Sao Paulo HVTU - CRT DST/AIDS CRS — São Paulo, Brazil
- Les Centres GHESKIO CRS — Port-au-Prince, Haiti
- Epidemiology Research & Training Unit Jamaica MOH CRS — Kingston, Jamaica
- Soweto HVTN CRS — Johannesburg, Gauteng, South Africa
- Emavundleni Desmond Tutu HIV Centre CRS — Cape Town, South Africa
- CAPRISA Aurum CRS — Klerksdorp, South Africa
Full record on ClinicalTrials.gov
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