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Development of a New HIV Vaccine

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.
 
ClinicalTrials.gov Identifier: NCT00051922
Recruitment Status : Completed
First Posted : January 22, 2003
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
The purpose of the study is to determine the safety of a new HIV vaccine and to evaluate the immune response to the vaccine. Only some HIV genes are used to make the vaccine and therefore the vaccine cannot itself cause HIV or AIDS.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: PolyEnv1 Phase 1

Detailed Description:

HIV-1 presents several challenges to vaccine design, including: 1) high mutation rates resulting in tremendous diversity of virus envelope, the target of neutralizing antibody, such that antibody elicited to one envelope may not protect from virus with a distinct envelope; 2) envelope from infected persons differs from envelopes obtained from T-cell line cultures, the usual source of envelope for vaccines; and 3) envelope glycoprotein exists as oligomers on the virion surface, not as the monomers used in previous vaccines. This study will test a new vaccine that has been designed to meet these challenges by delivering diverse, patient-derived, oligomeric envelopes to induce multiple type-specific responses capable of recognizing native envelope on natural variants. The vaccine vector used in this vaccine trial is recombinant vaccinia virus based on the NYCDH vaccinia isolate.

Participants in this study will receive the PolyEnv1 HIV vaccine and will be followed for one year. Laboratory tests will be performed at 10 study visits to monitor the participants' immunologic response and assess the safety of the vaccine. Patients will also have numerous HIV tests throughout the study period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Safety of a Polyvalent Vaccinia Virus HIV-1 Envelope Recombinant Vaccine (PolyEnv1) in Healthy Adults
Study Start Date : October 1997
Actual Primary Completion Date : July 2006
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Participants will receive vaccine and will be followed for 1 year
 Biological: PolyEnv1
Recombinant vaccinia virus vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability and safety of the PolyEnv1 vaccine [ Time Frame: Throughout study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-1 negative
  • Availability for one year of follow-up
  • No evidence of previous smallpox vaccination
  • Acceptable methods of contraception

Exclusion Criteria:

  • Immunosuppressive or chronic illness
  • Medical or psychological conditions which could affect compliance
  • High risk for HIV infection
  • Live attenuated vaccines within 60 days
  • Experimental agents within 30 days
  • Blood products within past 6 months
  • Eczema
  • Pregnant or lactating women
  • Household contact with immunodeficient person, pregnant woman, or child less than 12 months of age
  • Allergy to gentamicin
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00051922


Locations
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United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Patricia Flynn, MD Associate Member
Principal Investigator: Julia L. Hurwitz, PhD Member
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Patricia Flynn, MD, St. Jude's Children's Hospital
ClinicalTrials.gov Identifier: NCT00051922    
Other Study ID Numbers: P01AI045142 ( U.S. NIH Grant/Contract )
P01AI045142 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2003    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases