Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-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:
NCT00119873
First received: July 12, 2005
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine in HIV uninfected individuals.


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

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 I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade, Multivalent Recombinant Adenoviral Vector HIV Vaccine, VRC-HIVADV014-00-VP, in Healthy, HIV-1 Uninfected Adult Participants Who Have Low Titers of Pre-Existing Ad5 Neutralizing Antibodies

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Blood and chemical parameters for 12 months after injection
  • Local and systemic adverse reactions for 12 months after injection

Enrollment: 48
Study Completion Date: October 2006
Detailed Description:

The HIV epidemic is a major global health challenge. People in developing nations have limited access to life-sustaining antiretrovirals and account for over 95% of the 5 million new HIV infections annually. The development of a safe, effective, and widely accessible HIV vaccine is paramount in these areas. The adenoviral vector vaccine VRC-HIVADV014-00-VP has been shown to elicit a CD8 cytotoxic lymphocyte (CTL) response believed to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVADV014-00-VP in HIV uninfected adults. In this study, HIV uninfected individuals with low levels of pre-existing adenovirus neutralizing antibodies will receive different doses of the preventive vaccine to determine its safety, tolerability, and immunogenicity.

This study will last 1 year. Participants will be randomly assigned to one of two groups. At study entry, participants in each group will receive a single injection of either one of two doses of the adenoviral vector vaccine or placebo. Participants will record their temperature and other side effects in a symptom log on the day of vaccination and for 3 days thereafter. Participants will have seven clinic visits over 12 months. A physical exam, HIV and pregnancy prevention counseling, and blood and urine collection will occur at each visit. Participants will also be asked about side effects they may be experiencing and medications they are taking.

  Eligibility

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

Inclusion Criteria:

  • Have access to a participating site and are willing to be followed for the duration of the study
  • Willing to receive HIV test results
  • Able to understand and comply with study requirements
  • In good general health
  • Have neutralizing adenovirus antibody levels that are less than a 1:12 ratio
  • Agree to use acceptable methods of contraception for at least 21 days prior to study start and for the duration of the study.

Exclusion Criteria:

  • HIV infected
  • Positive hepatitis B surface antigen
  • Positive anti-hepatitis C virus antibodies
  • Prior receipt of an HIV vaccine
  • Immunosuppressive drugs within 168 days prior to first vaccination
  • Have received donated blood within 120 days prior to first vaccination
  • Have received immunoglobulin within 60 days of the first vaccination
  • Live attenuated vaccines or investigational research agents within 30 days prior to first vaccination
  • Subunit or killed vaccines within 14 days prior to first vaccination
  • Current preventive or therapeutic anti-tuberculosis (TB) treatment
  • Any medical, psychiatric, or social condition that would interfere with the study
  • Any occupational or other responsibility that would interfere with the study
  • Serious adverse reactions to vaccines
  • Autoimmune disease
  • Immunodeficiency
  • Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
  • Asthma. Participants who have had completely resolved childhood asthma are not excluded.
  • Diabetes mellitus type I or II. Participants who have had isolated gestational diabetes are not excluded.
  • Thyroid disease or removal of the thyroid
  • Blood vessel swelling within the last 3 years
  • Uncontrolled hypertension
  • Body mass index (BMI) of 40 or higher
  • Bleeding disorder
  • Cancer. Participants whose cancer has been removed and is unlikely to recur during the study are not excluded.
  • Seizure disorder. Participants who have not required medication or had a seizure for 3 years prior to study entry are not excluded.
  • Removal of the spleen or have a nonfunctioning spleen
  • Psychiatric conditions that may interfere with the study
  • Pregnancy, breastfeeding, or plan to become pregnant during the study
  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: NCT00119873

Locations
United States, California
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
United States, Tennessee
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
United States, Washington
FHCRC/UW Vaccine CRS
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Laurence Peiperl, MD San Francisco Department of Public Health
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00119873     History of Changes
Other Study ID Numbers: HVTN 054, 10121
Study First Received: July 12, 2005
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

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

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 July 23, 2014