Safety of and Immune Response to a DNA HIV Vaccine (pGA2/JS7) Boosted With a Modified Vaccinia HIV Vaccine (MVA/HIV62) in Healthy Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety of and immune response to a DNA HIV vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV uninfected adults.

Key facts

Study ID

NCT00301184

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

120

Starts

2006-04-01

Expected to finish

2008-12-01

Last updated by the study team

2022-08-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• HIV uninfected
• Has access to a participating HIV Vaccine Trials Unit (HVTU) and is willing to be followed for the duration of the study
• Understands vaccination procedure
• Willing to receive HIV test results
• Good general health
• Willing to use acceptable forms of contraception

You may not qualify if…

• Received HIV vaccines in prior HIV vaccine trial
• Received vaccinia vaccine. More information on this criterion can be found in the protocol.
• Recreational cocaine or methamphetamine use within 12 months prior to study entry
• Immunosuppressive medications within 168 days prior to first study vaccine administration. Participants who use corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
• Blood products within 120 days prior to first study vaccine administration
• Immunoglobulin within 60 days prior to first study vaccine administration
• Live attenuated vaccines within 30 days prior to first study vaccine administration
• Investigational research agents within 30 days prior to first study vaccine administration
• Subunit or killed vaccines within 14 days (for influenza or pneumococcal vaccines) or 30 days (for allergy treatment with antigen injections) prior to first study vaccine administration
• Current tuberculosis prophylaxis or therapy
• Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
• Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
• Any job-related responsibility that would interfere with the study
• Allergy to egg products
• Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
• History of or known active cardiac disease. More information on this criterion can be found in the protocol.
• Electrocardiogram (ECG) with clinically significant findings OR features that would interfere with assessments for myocarditis or pericarditis. More information on this criterion can be found in the protocol.
• Two or more of the following cardiac risk factors: elevated blood cholesterol (defined as fasting low density lipoprotein [LDL] of greater than 160 mg/dl); first-degree relative (e.g., mother, father, brother, sister) who had coronary artery disease before the age of 50; current smoker; or body mass index (BMI) greater than 35
• Autoimmune disease or immunodeficiency
• Active syphilis infection. Participants whose syphilis infection was fully treated at least 6 months prior to study entry are not excluded.
• Severe and unstable asthma
• Diabetes mellitus type 1 or 2
• Thyroid disease requiring treatment
• Serious angioedema within the past 2 years
• Uncontrolled hypertension OR systolic blood pressure (BP) of 150 mmHg or greater or diastolic BP of 100 mmHg or greater

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• Project Brave HIV Vaccine CRS — Baltimore, Maryland, United States
• Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
• Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
• Univ. of Rochester HVTN CRS — Rochester, New York, United States
• Vanderbilt Vaccine CRS — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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