NCT00001031

Brief Summary

To evaluate the safety and immunogenicity of SF-2 rgp120 vaccine in MF59 versus MN rgp120 vaccine in alum in volunteers who are seronegative for HIV-1. AS PER AMENDMENT 07/02/97: To determine the ability of immunization with MN rgp120/HIV-1 in combination with alum or SF-2 rgp120 in combination with MF59 to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who receive rsgp120/MN skin testing. The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to isolate. Thus, the identification of an immunogen that can elicit broadly neutralizing antibodies to HIV-1 is a major challenge in AIDS vaccine development. Two candidate vaccines, recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand testing into a larger population base, particularly targeting individuals at high risk for HIV infection.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for phase_2 hiv-infections

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Vaccines, SyntheticHIV-1HIV Envelope Protein gp120AIDS VaccinesHIV SeronegativityHIV Preventive Vaccine

Interventions

rgp120/HIV-1MNBIOLOGICAL
rgp120/HIV-1 SF-2BIOLOGICAL

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects must have:
  • Normal history and physical exam.
  • HIV negativity by ELISA.
  • CD4 count \>= 400 cells/mm3.
  • No clinically significant medical disease.
  • No history of immunodeficiency, autoimmune disease, or use of immunosuppressive medication.
  • No prior HIV vaccines.
  • Classification in one of the eligible risk groups defined in the Disease Status field.
  • Eligible higher risk groups:
  • Heterosexual teenagers and young adults (ages 16-28 permitted) who have attended a clinic for sexually transmitted diseases in the last 3 months or have higher risk sexual behavior.
  • Homosexually active males who are practicing higher risk behavior (ages 18-60).
  • Injection drug users active within the past 3 years (ages 18-60).
  • Heterosexual partners of HIV seropositive individuals (ages 18-60).
  • Eligible lower risk groups:
  • Homosexually active males who are practicing lower risk behavior (ages 18-60).
  • +1 more criteria

You may not qualify if:

  • Prior Medication:
  • Excluded:
  • Prior HIV vaccines.
  • Prior immunosuppressive medications.
  • Experimental agents within the past 30 days.
  • AS PER AMENDMENT 07/02/97: Use of systemic steroids in the past month (for volunteers undergoing DTH testing).
  • AS PER AMENDMENT 07/02/97:
  • History of eczema or allergic-type reactions to vaccines used in protocol 201 (for volunteers undergoing DTH testing).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UAB AVEG

Birmingham, Alabama, United States

Location

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63104, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 02115, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

JHU AVEG

Pittsburgh, Pennsylvania, United States

Location

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

UW - Seattle AVEG

Seattle, Washington, 98195, United States

Location

Related Publications (5)

  • McElrath MJ, Corey L, Clements ML, Belshe R, Keefer M, Graham B, Fast P, Matthews T, Duliege AM, Francis D. A phase II HIV vaccine trial in seronegative subjects: safety, immunogenicity, and future directions. Int Conf AIDS. 1994 Aug 7-12;10(1):91 (abstract no 317A)

    BACKGROUND

  • McElrath MJ, Montefiori DM, Clements ML, Belshe RB, Dolin R, Graham BS, Duliege A-M, Francis D, Bolognesi DP, Matthews TJ, Wolff M, Fast P, Corey L. Longitudinal vaccine-induced immunity and risk behavior of study participants of AVEG phase II protocol 201. Conf Adv AIDS Vaccine Dev. 1996 Feb 11-15;216 [Poster 96]

    BACKGROUND

  • McElrath MJ, Corey L, Montefiori D, Wolff M, Schwartz D, Keefer M, Belshe R, Graham BS, Matthews T, Wright P, Gorse G, Dolin R, Berman P, Francis D, Duliege AM, Bolognesi D, Stablein D, Ketter N, Fast P. A phase II study of two HIV type 1 envelope vaccines, comparing their immunogenicity in populations at risk for acquiring HIV type 1 infection. AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 2000 Jun 10;16(9):907-19. doi: 10.1089/08892220050042846.

    PMID: 10875616BACKGROUND

  • Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Nov 1;10(3):386-90.

    PMID: 7552502BACKGROUND

  • McElrath MJ, Montefiori D, Wolff M, Clements M, Gorse G, Keefer M, Graham B, Duliege AM, Francis D, Matthews T, Fast P, Corey L. Safety, immunity, and risk behavior in HIV-1-uninfected volunteers representing diverse risk populations following recombinant envelope vaccinations: a three-year followup. Int Conf AIDS. 1996 Jul 7-12;11(1):10 (abstract no MoA284)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Corey L

    STUDY CHAIR

  • McElrath J

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

December 1, 1997

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(7)