Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given Three Different Ways to HIV Uninfected Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers (intradermally), or under the skin (subcutaneously). NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.

Key facts

Study ID

NCT00384787

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

90

Starts

2006-11-01

Expected to finish

2012-12-01

Last updated by the study team

2021-10-14

Who can join

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

You may qualify if…

• HIV-1 and -2 uninfected
• Good general health
• Pre-existing adenovirus 5 (Ad5) neutralizing antibody titers of a 1:12 ratio or greater
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
• Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
• Willing to receive HIV test results
• Able to understand the vaccination procedure
• Willing to use acceptable forms of contraception

You may not qualify if…

• HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
• Immunosuppressive medications within 168 days prior to first study vaccination
• Blood products within 120 days prior to first study vaccination
• Immunoglobulin within 60 days prior to first study vaccination
• Live attenuated vaccines within 30 days prior to first study vaccination
• Investigational research agents within 30 days prior to first study vaccination
• Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
• Allergy treatment with antigen injections within 30 days prior to first study vaccination
• Current anti-tuberculosis (TB) preventive therapy or treatment
• Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
• 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
• Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
• Autoimmune disease or immunodeficiency
• Active syphilis infection. Participants who have been fully treated for syphilis more than 6 months prior to study entry are not excluded.
• Moderate to severe asthma. More information on this criterion can be found in the protocol.
• Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
• Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry
• Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry if episodes are considered serious or have required medication in the 2 years prior to study entry
• Uncontrolled hypertension
• Body mass index (BMI) of 40 or greater OR BMI of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol.
• Bleeding disorder
• Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
• Seizure disorder
• Absence of the spleen

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
• NY Blood Ctr./Union Square CRS — New York, New York, United States
• Columbia P&S CRS — New York, New York, United States
• NY Blood Ctr./Bronx CRS — The Bronx, New York, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
• ACSA CRS — Iquitos, Maynas, Peru

Full record on ClinicalTrials.gov

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