Status:
COMPLETED
Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine in HIV uninfected individuals.
Detailed Description
The HIV epidemic is a major global health challenge. People in developing nations have limited access to life-sustaining antiretrovirals and account for over 95% of the 5 million new HIV infections an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Removal of the spleen or have a nonfunctioning spleen
- Psychiatric conditions that may interfere with the study
- Pregnancy, breastfeeding, or plan to become pregnant during the study
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00119873
End Date
October 1 2006
Last Update
October 14 2021
Active Locations (3)
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1
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
2
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
3
FHCRC/UW Vaccine CRS
Seattle, Washington, United States, 98104