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A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000832
First Posted: August 31, 2001
Last Update Posted: May 24, 2012
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.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers.

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.


Condition Intervention Phase
HIV Infections Biological: MF59 Biological: rgp120/HIV-1 SF-2 Phase 1

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

Resource links provided by NLM:


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

Enrollment: 30
Study Completion Date: January 1998
Detailed Description:

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Volunteers must have:

  • Normal history and physical exam.
  • HIV negativity.
  • Absolute CD4 count >= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • Lower risk sexual behavior.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

  • Positive hepatitis B surface antigen.
  • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
  • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
  • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.

Subjects with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
  • History of cancer unless there has been surgical excision that is considered to have achieved cure.

Prior Medication:

Excluded:

  • Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
  • Experimental agents within 30 days prior to study entry.
  • Prior HIV vaccines.

Prior Treatment:

Excluded:

  • Blood products or immunoglobulin within the past 6 months.

Identifiable high-risk behavior for HIV infection, including:

  • History of injection drug use within past 12 months.
  • Higher risk sexual behavior.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000832


Locations
United States, Alabama
UAB AVEG
Birmingham, Alabama, United States, 35294
United States, Missouri
St. Louis Univ. School of Medicine AVEG
St. Louis, Missouri, United States, 63104
United States, New York
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
United States, Pennsylvania
JHU AVEG
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Corey L
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000832     History of Changes
Other Study ID Numbers: AVEG 024
10575 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: May 24, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
MF59 oil emulsion
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs