Trial record 1 of 1 for:    NCT00124007
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Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00124007
First received: July 22, 2005
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.


Condition Intervention Phase
HIV Infections
Biological: VRC-HIVADV014-00-VP
Biological: VRC-HIVDNA016-00-VP
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: A Phase I, 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 or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Local reactogenicity signs and symptoms
  • systemic reactogenicity signs and symptoms
  • laboratory measures of safety
  • adverse and serious adverse experiences

Secondary Outcome Measures:
  • Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
  • proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
  • proportion of volunteers with increase in antibodies to rAd5
  • impact of pre-existing immunity to rAd5 on immunogenicity
  • proportion of volunteers who test "false positive" on standard HIV testing algorithm.

Enrollment: 114
Study Start Date: November 2005
Study Completion Date: April 2007
Detailed Description:

The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine, VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine, VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. HIV uninfected volunteers will be recruited in Kenya and Rwanda.

Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups:

  • Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry.
  • Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry.
  • Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6.
  • Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6.

All participants will undergo vital signs measurements before and after receiving each vaccination.

Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.

Participants in Groups C and D will have 17 study visits over 12 months. A physical exam, adverse events reporting, 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:

  • Willing to follow all the requirements of the study and available for follow-up for the duration of the study
  • Have understanding of the study and provide written informed consent
  • Willing to undergo HIV testing and counseling and willing to receive HIV test results
  • Willing to use acceptable forms of contraception

Exclusion Criteria:

  • HIV infected
  • Hepatitis B virus infected
  • Hepatitis C virus infected
  • Active or untreated syphilis
  • Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
  • Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry
  • Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study
  • Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study
  • Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study
  • Blood transfusion or blood products within 120 days prior to study entry
  • Immunoglobulin within 60 days prior to study entry
  • Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study
  • Any other investigational HIV vaccine at any time
  • History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions
  • Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry
  • Uncontrolled hypertension
  • Pregnant, breastfeeding, or plan to become pregnant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124007

Locations
Kenya
KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi
Kilifi, Kenya
KAVI, KNH at Kangemi
Nairobi, Kenya
Rwanda
Projet San Francisco
Kigali, Rwanda
Sponsors and Collaborators
Investigators
Principal Investigator: Job Bwayo, MD, PhD Kenya AIDS Vaccine Initiative, University of Nairobi
Principal Investigator: Etienne Karita, MD Project San Francisco
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00124007     History of Changes
Other Study ID Numbers: IAVI V001, 10380
Study First Received: July 22, 2005
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

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

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 August 27, 2014