Status:
COMPLETED
Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-...
Detailed Description
The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an...
Eligibility Criteria
Inclusion
- Willing to follow all the requirements of the study and available for follow-up for the duration of the study
- Have understanding of the study and provide written informed consent
- Willing to undergo HIV testing and counseling and willing to receive HIV test results
- Willing to use acceptable forms of contraception
Exclusion
- HIV infected
- Hepatitis B virus infected
- Hepatitis C virus infected
- Active or untreated syphilis
- Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
- Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study
- Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study
- Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study
- Blood transfusion or blood products within 120 days prior to study entry
- Immunoglobulin within 60 days prior to study entry
- Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study
- Any other investigational HIV vaccine at any time
- History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions
- Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry
- Uncontrolled hypertension
- Pregnant, breastfeeding, or plan to become pregnant
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00124007
Start Date
November 1 2005
End Date
April 1 2007
Last Update
November 1 2021
Active Locations (3)
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1
KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi
Kilifi, Kenya
2
KAVI, KNH at Kangemi
Nairobi, Kenya
3
Projet San Francisco
Kigali, Rwanda