a study on HIV/AIDS
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.
A Phase 1 Clinical Trial to Evaluate the Immunogenicity of AIDSVAX B/E Bivalent gp120 Vaccine and MVA/HIV62B in Healthy, HIV-1-Uninfected Adult Participants Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205
This study will evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens as part of the HVTN 205 study.
Participants in this study will be assigned to one of five groups based on their previous vaccine regimen received in HVTN 205. Depending on their group, participants will receive the MVA/HIV62B vaccine, the AIDSVAX B/E vaccine, or both the MVA/HIV62B vaccine and the AIDSVAX B/E vaccine. All participants will receive their assigned vaccines at study entry (Day 0) and Month 4. Participants will attend several study visits through Month 10. Visits will include physical examinations, blood collection, HIV testing and risk reduction counseling, and interviews and questionnaires. Optional procedures at some visits include collection of rectal fluids, cervical fluids, and semen. Study staff will contact participants 2 years following the initial study injection for follow-up health monitoring.
HIV Infections Vaccines
Open to people ages 18 years to 55 years
General and Demographic Criteria:
Prior participation in HVTN 205 with assignment to treatment (not placebo) arm:
Laboratory Inclusion Values:
Hemogram/Complete Blood Count (CBC)
Platelets equal to 125,000 to 550,000/mm^3
Cardiac Troponin T or I (cTnT or cTnI) does not exceed the institutional upper limit of normal
Negative anti-hepatitis C virus Ab (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick,a microscopic urinalysis with red blood cells levels within institutional normal range).
Effective contraception is defined as using the following methods:
Active duty and reserve U.S. military personnel
Vaccines and Other Injections
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
ECG with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, as determined by a contract ECG Lab or cardiologist,including any of the following: (1) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS greater than or equal to 120 ms, PR interval greater than or equal to 220ms, any 2nd or 3rd degree AV block, or QTc prolongation (greater than 450ms)); (2)repolarization (ST segment or T wave) abnormality that will interfere with the assessment of myo/pericarditis; (3) significant atrial or ventricular arrhythmia; (4)frequent atrial or ventricular ectopy (eg, frequent premature atrial contractions, 2 premature ventricular contractions in a row); (5) ST elevation consistent with ischemia; (6) evidence of past or evolving myocardial infarction
Clinically Significant Medical Conditions
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02852005.
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