Development of a New HIV Vaccine

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00051922
First received: January 17, 2003
Last updated: June 6, 2011
Last verified: June 2011

January 17, 2003
June 6, 2011
October 1997
July 2006   (final data collection date for primary outcome measure)
Tolerability and safety of the PolyEnv1 vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00051922 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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
Both
18 Years to 32 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051922
P01AI45142, P01 AI45142
Not Provided
Patricia Flynn, MD, St. Jude's Children's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
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