Status:
COMPLETED
Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.
Detailed Description
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was developed to in...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Understanding of vaccination procedure
- Willing to receive HIV test results and provide informed consent
- Good general health
- HIV negative
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
- Not pregnant and agrees to use acceptable forms of contraception
- Exclusion Criteria
- HIV vaccines or placebo in a prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to study
- Blood products within 120 days prior to study
- Immunoglobulin within 60 days prior to study
- Live attenuated vaccines within 30 days prior to study
- Investigational research agents within 30 days prior to study
- Medically indicated subunit or killed vaccines within 14 days prior to study
- Current anti-tuberculosis prophylaxis or therapy
- Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
- Autoimmune disease or immunodeficiency
- Active syphilis infection
- Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
- Diabetes mellitus; a participant with past gestational diabetes is not excluded
- Thyroid disease, including removal of thyroid and diagnoses requiring medication
- Serious angioedema
- Hypertension
- Diagnosis of bleeding disorder
- Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
- Seizure disorder requiring medication within the last 3 years
- Absence of the spleen
- Mental illness that would interfere with compliance with the protocol
- Pregnant or breastfeeding
- Two or more elevated liver function tests
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00071851
Start Date
December 1 2003
End Date
October 1 2005
Last Update
October 14 2021
Active Locations (14)
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1
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
2
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States, 94102
3
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States, 21201
4
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, United States, 21205