Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
HIV Vaccine Trials Network
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 serotyp...
Detailed Description
The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of a safe and effective vaccine that will prevent HIV infection. Vaccines using a DNA plasmid to prime the re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Other conditions that, in the judgment of the investigator, would interfere with the study
- Pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00472719
Start Date
August 1 2007
End Date
January 1 2013
Last Update
October 14 2021
Active Locations (7)
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1
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
2
Bridge HIV CRS
San Francisco, California, United States, 94143
3
Columbia P&S CRS
New York, New York, United States, 10032-3732
4
New York Blood Center CRS
New York, New York, United States, 10065