Status:
COMPLETED
Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
United States Department of Defense
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP, in HIV uninfected adults ...
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
- Good general health
- Willing to follow all the requirements of the study and available for follow-up for the duration of the study (14 to 16 months)
- Able and willing to provide informed consent
- Willing to undergo HIV testing and counseling and willing to receive HIV test results
- Willing to not engage in high-risk behavior for HIV infection during the study
- Willing to provide location and be visited at home
- Willing to be identified with picture identification for study purposes
- Willing to use acceptable forms of contraception
- Pregnant women and those with conditions which render phlebotomy volumes hazardous will be allowed to participate using a minimized phlebotomy schedule
Exclusion
- HIV or HBV infection
- HIV vaccines in prior HIV vaccine trial
- Immunosuppressive or cytotoxic medications within the 6 months prior to study entry. Participants who have used corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for acute uncomplicated dermatitis are not excluded.
- Blood products within 120 days prior to study entry
- Immunoglobulin within 60 days prior to study entry
- Live attenuated vaccines within 30 days prior to first study vaccine administration
- Medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days prior to first study vaccine administration
- Investigational research agents within 30 days prior to first study vaccine administration
- Current tuberculosis prophylaxis or therapy
- 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.
- Serious adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Unstable asthma or asthma requiring emergent or urgent care, hospitalization, intubation, or oral or intravenous corticosteroids during the 2 years prior to study entry
- Diabetes mellitus type 1 or 2. Patients with gestational diabetes are not excluded.
- Thyroid disease, including removal of thyroid or disease requiring medication within 3 years prior to study entry
- Serious angioedema within 3 years prior to study entry or disease requiring medication within 2 years prior to study entry
- Uncontrolled hypertension
- Bleeding disorder
- Active syphilis
- Active cancer OR treated cancer that may recur during the duration of the study
- Seizure disorder. Participants who have had fever-related seizures prior to age 2 are not excluded.
- Absence of spleen OR partial or complete lack of splenic function
- Psychiatric condition that may interfere with the study, including past or present psychoses, bipolar disorder, or suicidal attempts
- Any medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with the study
- Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
- Pregnancy, breastfeeding, or plan to become pregnant
- Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
- Incapacitating illness precluding clinic visits
- Unable to provide informed consent
- Prisoners will not be enrolled while incarcerated and if enrolled prior to incarceration, will not be followed while in confinement. Re-consent will not be required upon release from prison.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00123968
Start Date
May 1 2006
End Date
June 1 2012
Last Update
November 9 2021
Active Locations (3)
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1
Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho
Kericho, Kenya, 20200
2
National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) CRS
Mbeya, Tanzania, 025
3
Makerere University Walter Reed Project (MUWRP)
Kampala, Uganda