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Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
International AIDS Vaccine Initiative
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00415649
First received: December 21, 2006
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and tolerability of and immune response to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults at risk for HIV infection.


Condition Intervention Phase
HIV Infections
 Biological: VRC-HIVDNA016-00-VP
Biological: VRC-HIVADV014-00-VP
Biological: Vaccine placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine in Healthy Adult Volunteers at Risk for HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • immunogenicity as assessed by the proportion of participants who develop HIV-specific T-cell responses and/or to ENV A-, B-, or C-specific antibodies and magnitude of those responses [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: A
DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6.
 Biological: VRC-HIVDNA016-00-VP Biological: VRC-HIVADV014-00-VP
Placebo Comparator: B
Placebo vaccine
 Biological: Vaccine placebo
Placebo comparator

Detailed Description:

Due to the availability of antiretroviral therapy, AIDS-related deaths have lessened in the United States. However, these therapies are widely inaccessible to the developing world. The need for a safe and affordable vaccine that will prevent HIV infection is of utmost importance. To generate a broadly protective vaccine, it is necessary to develop a multivalent vaccine containing a defined combination of immunogens from the most globally prevalent HIV subtypes. This study will evaluate the safety, tolerability, and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine,VRC-HIVDNA016-00-VP, followed by a multiclade recombinant HIV-1 adenoviral vector vaccine, HIVADV014-00-VP.

This study will last about 27 months. Participants will be randomly assigned to one of two groups. Group A will receive the DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6; Group B will receive placebo. There will be 20 study visits over 2 years. Physical exams, vital signs measurements, adverse event evaluation, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At risk for HIV
  • Have had sexual intercourse with an HIV infected partner OR have had sexual intercourse with more than one person within the 3 months prior to study entry OR infected with a sexually transmitted disease within the 3 months prior to study entry
  • Willing to comply with the protocol
  • Willing to undergo HIV testing and HIV counseling and receive HIV test results
  • Willing to use acceptable forms of contraception

Exclusion Criteria:

  • HIV-1 or HIV-2 infected
  • History of immunodeficiency or autoimmune disease
  • Use of corticosteroids or immunosuppressive, antiviral, anticancer, or other medications considered significant by investigator within 6 months prior to study entry
  • Certain abnormal laboratory values
  • Acute or chronic medical condition considered progressive
  • Hepatitis B or hepatitis C virus infection or untreated syphilis
  • Live attenuated vaccine within 30 days prior to study
  • Planned receipt of investigational product within 30 days after first vaccination
  • Other medically indicated subunit or killed vaccine within 14 days prior to study entry
  • Planned receipt of other medically killed vaccine investigational product within 14 days after first vaccination
  • Blood transfusion within 120 days of study entry
  • Immunoglobulin within 60 days of study entry
  • Participation within the last 3 months, or planned participation in another clinical study of investigational product currently or during the course of this study
  • Another investigational HIV vaccine at any time
  • History of severe local or systemic reactogenicity to vaccines
  • History of severe allergic reactions
  • History of recurrent urticaria
  • Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or ideation in the 3 years prior to study entry
  • Uncontrolled hypertension
  • Pregnant, breastfeeding, or planning to become pregnant within 4 months following last study vaccination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415649

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
International AIDS Vaccine Initiative
Investigators
Study Chair: Pontiano Kaleebu, MD, PhD Medical Research Council/Uganda Viral Research Institute (UVRI) Uganda Research Unit on AIDS, UVRI/International AIDS Vaccine Initiative HIV Vaccine Program
  More Information

Additional Information:
Click here for more information on preventive HIV vaccines  This link exits the ClinicalTrials.gov site
Haga clic aquí para ver información sobre este ensayo clínico en español  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00415649     History of Changes
Other Study ID Numbers: IAVI V002, 10419
Study First Received: December 21, 2006
Last Updated: March 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Preventive Vaccine
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 14, 2013