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
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho
- National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) CRS
- Makerere University Walter Reed Project (MUWRP)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
1A
1B
1C
1D
2A
2B
Participants will receive a low dose of the adenovirus-vectored HIV vaccine or placebo at study entry
Participants will receive a higher dose of the adenovirus-vectored HIV vaccine or placebo at study entry
Participants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a low dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
Participants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a higher dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
Participants will receive the DNA plasmid vaccine at study entry and Days 28 and 56. They will also receive a low dose of the adenovirus-vectored HIV vaccine at Day 168.
Participants will receive the DNA plasmid vaccine placebo at study entry and Days 28 and 56. They will also receive a the adenovirus-vectored HIV vaccine placebo at Day 168.