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

January 17, 2003
January 22, 2003
June 8, 2011
October 1997
July 2006   (Final data collection date for primary outcome measure)
Tolerability and safety of the PolyEnv1 vaccine [ Time Frame: Throughout study ]
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Complete list of historical versions of study NCT00051922 on Archive Site
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Development of a New HIV Vaccine
Evaluation of the Safety of a Polyvalent Vaccinia Virus HIV-1 Envelope Recombinant Vaccine (PolyEnv1) in Healthy Adults
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.

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.

Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
Biological: PolyEnv1
Recombinant vaccinia virus vaccine
Experimental: 1
Participants will receive vaccine and will be followed for 1 year
Intervention: Biological: PolyEnv1

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2009
July 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 32 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P01AI045142( U.S. NIH Grant/Contract )
P01AI045142 ( U.S. NIH Grant/Contract )
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Patricia Flynn, MD, St. Jude's Children's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Patricia Flynn, MD Associate Member
Principal Investigator: Julia L. Hurwitz, PhD Member
National Institute of Allergy and Infectious Diseases (NIAID)
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP