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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415649
Recruitment Status : Withdrawn
First Posted : December 25, 2006
Last Update Posted : March 21, 2012
International AIDS Vaccine Initiative
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Biological: VRC-HIVDNA016-00-VP Biological: VRC-HIVADV014-00-VP Biological: Vaccine placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites [ Time Frame: throughout study ]
  2. safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus [ Time Frame: throughout study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415649

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
International AIDS Vaccine Initiative
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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

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00415649    
Other Study ID Numbers: IAVI V002
10419 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Preventive Vaccine
HIV Seronegativity
Additional relevant MeSH terms:
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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