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Safety of an HIV Vaccine (AVX101) in HIV Uninfected Volunteers in the United States and South Africa
This study has been completed.

First Received on July 7, 2003.   Last Updated on October 26, 2010   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00063778
  Purpose

The purpose of this study is to see if different doses of an experimental HIV vaccine are safe and to study how the immune system responds to the vaccine. The vaccine will be tested in healthy, HIV uninfected volunteers. AVX101 contains only one of the many substances that HIV needs to make more copies of itself; therefore, the vaccine cannot cause HIV or AIDS.


Condition Intervention Phase
HIV Infections
Biological: AVX101
Phase I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase I Safety and Immunogenicity Trial of an Alphavirus Replicon HIV Subtype C Gag Vaccine (AVX101, Alphavax, Inc.) in Healthy HIV-1 Uninfected Adult Volunteers

Resource links provided by NLM:


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

Estimated Enrollment: 96
Detailed Description:

This study will evaluate the safety and immunogenicity of an alphavirus replicon HIV subtype C gag vaccine. This vaccine utilizes a propagation-defective replicon vector system derived from an attenuated strain of Venezuelan Equine Encephalitis (VEE) virus. The vaccine replicon expresses the gag gene from a South African subtype C isolate of HIV-1.

This study will evaluate the AVX101 vaccine in healthy, HIV uninfected volunteers in both the United States and South Africa. Participants will be randomized to receive either vaccine or placebo at study entry and again at Months 1 and 3. The study will involve four groups of participants in both the US and South Africa, with successive groups receiving increasing doses of the vaccine. Twelve US participants (US Group 1) will be randomized to receive either vaccine or placebo. After a review of initial safety data from this group, 12 South African participants (SA Group 1) will be randomized to receive the same vaccine dose as US Group 1 or placebo, while 12 US participants (US Group 2) will be randomized to receive the next higher vaccine dose or placebo. Review of safety data from SA Group 1 and US Group 2 will inform the decision to begin enrollment into SA Group 2 and US Group 3. This process of review and dose escalation will continue until the study has enrolled participants into all four SA and US Groups or until dose escalation is stopped due to safety concerns.

Participants will have nine study visits over 12 months. Study visits will include clinical evaluation, urine and blood tests, and HIV tests. After each injection, participants will be asked to record their temperature and any symptoms each day for 7 days and report them to the clinic staff.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • HIV negative
  • Willing to receive HIV test results
  • Good general health
  • Acceptable methods of contraception for females of reproductive potential
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
  • Access to participating site and available for follow-up during the 12 month study

Exclusion Criteria

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Measurable anti-VEE antibody
  • High risk for HIV infection according to HVTN Risk Criteria
  • Immunosuppressive medications within 168 days prior to first study vaccine administration
  • Blood products within 120 days prior to first study vaccine administration
  • Immunoglobulin within 60 days prior to first study vaccine administration
  • Live attenuated vaccines within 30 days prior to first study vaccine administration
  • Investigational research agents within 30 days prior to first study vaccine administration
  • Subunit or killed vaccines within 14 days prior to first study vaccine administration
  • Current tuberculosis prophylaxis or therapy
  • Active syphilis
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Unstable asthma
  • Type 1 or Type 2 Diabetes Mellitus
  • Thyroid disease requiring treatment
  • Serious angioedema within the past 3 years
  • Uncontrolled hypertension
  • Bleeding disorder
  • Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
  • Seizure disorder requiring medication within the past 3 years
  • Asplenia
  • Mental illness that would interfere with compliance with the protocol
  • Other conditions that, in the judgement of the investigator, would interfere with the study
  • Pregnant or breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063778

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205-1901
United States, New York
New York Blood Ctr- Union Square
Bronx, New York, United States, 10456
Columbia University
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642-0002
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
South Africa
SAAVI Vaccine Research Unit
Durban, South Africa
Chris Hani Baragwanath Hospital
Soweto, South Africa
Sponsors and Collaborators
Investigators
Study Chair: Donald Burke, MD Johns Hopkins University
Study Chair: Salim Abdool Karim, MD, PhD University of Natal, Durban, South Africa
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00063778     History of Changes
Other Study ID Numbers: HVTN 040
Study First Received: July 7, 2003
Last Updated: October 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventive Vaccine
AIDS Vaccines
Gene Products, gag
HIV-1
Dose-Response Relationship, Immunologic
Injections, Subcutaneous

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 February 12, 2012