Safety of and Immune Response to a DNA HIV Vaccine Followed By Boosting With One of Two Serotypes of Adenoviral Vector HIV Vaccine 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 an experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5 followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV uninfected adults.

Key facts

Study ID

NCT00472719

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

17

Starts

2007-08-01

Expected to finish

2013-01-01

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
• Have access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
• Willing to receive HIV test results
• Good general health
• Pre-existing adenovirus 5 (Ad5) neutralizing antibody titer of 1:1000 ratio or greater
• Willing to use acceptable forms of contraception from at least 21 days prior to enrollment through the duration of the study

You may not qualify if…

• HIV vaccines in prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to first study vaccine administration
• 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 prior to first study vaccine administration
• Current anti-tuberculosis prophylaxis or therapy
• 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.
• Serious adverse reaction to vaccines. Participants who have had an adverse reaction to pertussis vaccine as a child are not excluded.
• Autoimmune disease or immunodeficiency
• Active syphilis infection. Participants with fully treated syphilis at least 6 months prior to study entry are not excluded.
• Unstable asthma. More information about this criterion can be found in the protocol.
• Diabetes mellitus type 1 or 2. Participants with a history of isolated gestational diabetes are not excluded.
• Absence of thyroid or thyroid disease requiring treatment
• Serious angioedema within the past 3 years or requiring medication within 2 years of study entry
• Body mass index (BMI) of 40 or less OR BMI of 35 or less if certain other criteria apply. More information about these criteria can be found in the protocol.
• Uncontrolled hypertension
• Bleeding disorder
• Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
• Seizure disorder
• Absence of spleen
• Certain abnormal laboratory values
• Mental illness that would interfere with compliance with the protocol

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• Bridge HIV CRS — San Francisco, California, United States
• Columbia P&S CRS — New York, New York, United States
• New York Blood Center CRS — New York, New York, United States
• University of Rochester Vaccines to Prevent HIV Infection CRS — Rochester, New York, United States
• Vanderbilt Vaccine (VV) CRS — Nashville, Tennessee, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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