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
  Purpose

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 Intervention Phase
HIV Infections
Biological: PolyEnv1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tolerability and safety of the PolyEnv1 vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: October 1997
Study Completion Date: June 2009
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive vaccine and will be followed for 1 year
Biological: PolyEnv1
Recombinant vaccinia virus vaccine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 32 Years
Genders Eligible for Study:   Both
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
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: NCT00051922

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Investigators
Principal Investigator: Patricia Flynn, MD Associate Member
Principal Investigator: Julia L. Hurwitz, PhD Member
  More Information

Additional Information:
Publications:

Responsible Party: Patricia Flynn, MD, St. Jude's Children's Hospital
ClinicalTrials.gov Identifier: NCT00051922     History of Changes
Other Study ID Numbers: P01AI45142, P01 AI45142
Study First Received: January 17, 2003
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

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

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 28, 2014