Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults
Completed · Phase 1
Conditions studied: HIV Infections
In brief
The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine in HIV uninfected individuals.
Key facts
- Study ID
- NCT00119873
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 48
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2021-10-14
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Have access to a participating site and are willing to be followed for the duration of the study
- Willing to receive HIV test results
- Able to understand and comply with study requirements
- In good general health
- Have neutralizing adenovirus antibody levels that are less than a 1:12 ratio
- Agree to use acceptable methods of contraception for at least 21 days prior to study start and for the duration of the study.
You may not qualify if…
- HIV infected
- Positive hepatitis B surface antigen
- Positive anti-hepatitis C virus antibodies
- Prior receipt of an HIV vaccine
- Immunosuppressive drugs within 168 days prior to first vaccination
- Have received donated blood within 120 days prior to first vaccination
- Have received immunoglobulin within 60 days of the first vaccination
- Live attenuated vaccines or investigational research agents within 30 days prior to first vaccination
- Subunit or killed vaccines within 14 days prior to first vaccination
- Current preventive or therapeutic anti-tuberculosis (TB) treatment
- Any medical, psychiatric, or social condition that would interfere with the study
- Any occupational or other responsibility that would interfere with the study
- Serious adverse reactions to vaccines
- Autoimmune disease
- Immunodeficiency
- Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
- Asthma. Participants who have had completely resolved childhood asthma are not excluded.
- Diabetes mellitus type I or II. Participants who have had isolated gestational diabetes are not excluded.
- Thyroid disease or removal of the thyroid
- Blood vessel swelling within the last 3 years
- Uncontrolled hypertension
- Body mass index (BMI) of 40 or higher
- Bleeding disorder
- Cancer. Participants whose cancer has been removed and is unlikely to recur during the study are not excluded.
- Seizure disorder. Participants who have not required medication or had a seizure for 3 years prior to study entry are not excluded.
Where it is running
- San Francisco Vaccine and Prevention CRS — San Francisco, California, United States
- Vanderbilt Vaccine CRS — Nashville, Tennessee, United States
- FHCRC/UW Vaccine CRS — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.