A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults

This study has been completed.
Sponsor:
Collaborators:
Biocine
Genentech
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001031
First received: November 2, 1999
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: rgp120/HIV-1MN
Biological: rgp120/HIV-1 SF-2
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults

Resource links provided by NLM:


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

Enrollment: 296
Study Completion Date: December 1997
Detailed Description:

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.

HIV-seronegative volunteers (including four populations at higher risk for HIV infection and two populations at lower risk) receive one of four regimens. Two treatment groups receive 50 mcg SF-2 rgp 120 (BIOCINE) in MF59 adjuvant or 600 mcg MN rgp120 (Genentech) in alum. Two control groups receive vehicle (placebo) in MF59 adjuvant alone or alum adjuvant alone. Immunizations are given at months 0, 1, and 6. AS PER AMENDMENT 10/93: patients enrolled by June 15, 1993, receive a fourth immunization at month 12 or 18 (50 percent of patients for each schedule). Patients are followed until 2 years after the first injection. AS PER AMENDMENT 05/10/94: a special study of vaccine acceptability and HIV-related risk behavior will be conducted at some time between months 12 and 18. AS PER AMENDMENT 07/02/97: a special DTH study will be conducted in consenting volunteers who have received three or four immunizations. The injections will be given at the end of the study (on or after day 1, & 56). Followup is extended to 56 days after administration of the intradermal injection.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

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).
  • Adult women and heterosexual adult men practicing lower risk sexual behavior (ages 18-60).

Exclusion Criteria

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).
  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: NCT00001031

Locations
United States, Alabama
UAB AVEG
Birmingham, Alabama, United States
United States, Missouri
St. Louis Univ. School of Medicine AVEG
St. Louis, Missouri, United States, 63104
United States, New York
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Univ. of Rochester AVEG
Rochester, New York, United States, 02115
United States, Pennsylvania
JHU AVEG
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
United States, Washington
UW - Seattle AVEG
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Biocine
Genentech
Investigators
Study Chair: Corey L
Study Chair: McElrath J
  More Information

Publications:
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)
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]
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)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001031     History of Changes
Other Study ID Numbers: AVEG 201, 10588
Study First Received: November 2, 1999
Last Updated: May 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
HIV-1
HIV Envelope Protein gp120
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

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
Aluminum Hydroxide
Aluminum sulfate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014