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Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rgp120/HIV-1 SF-2
MTP-PE/MF59
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Adjuvants, Immunologic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Patients must have: Normal history and physical exam. No identifiable high-risk behavior for HIV infection. Negative ELISA for HIV. Normal cell-mediated immune responses using Merieux skin test. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant evidence of depression. Positive syphilis serology (e.g., RPR) that is documented not to be a false positive or from a remote (> 6 months) treated infection. Circulating Hepatitis B antigenemia. More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months. Patients with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. Significant evidence of depression or under treatment for psychiatric problems within the past year. History of anaphylaxis or other adverse vaccine reactions. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) within the past 6 months. Prior Medication: Excluded: Immunoglobulin or vaccines within the past 2 months. Experimental agents within the past 30 days. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 3 months. Risk Behavior: Excluded: History of IV drug use within the past year. More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months.

Sites / Locations

  • St Louis Univ School of Medicine
  • Univ of Pennsylvania at Philadelphia
  • Vanderbilt Univ Hosp
  • Children's Hospital & Medical Center / Seattle ACTU

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 29, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Biocine
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1. Study Identification

Unique Protocol Identification Number
NCT00001019
Brief Title
Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant
Official Title
A Phase I Clinical Trial to Evaluate:Part A. The Safety and Immunogenicity of Two Dose Levels of SF-2 gp120 (CHO) With or Without MTP-PE Adjuvant in the MF59 Emulsion Part B. The Safety and Immunogenicity of Five Monthly Doses of 50 mcg gp120 Protein in MF59 Emulsion (Without MTP-PE) Versus the Emulsion Control
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Biocine

4. Oversight

5. Study Description

Brief Summary
Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months. Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections. One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine.
Detailed Description
One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine. In Part A, 32 volunteers (eight on each of four treatment arms) are randomized to receive one of two doses (15 or 50 mcg) of gp120 vaccine with either MTP-PE/MF59 adjuvant emulsion or MF59 emulsion alone. The volunteers receive three IM injections at 0, 1, and 6 months. In Part B, 16 female volunteers (eight on each of two treatment arms) are randomized to receive either MF59 emulsion alone (placebo) or MF59 emulsion plus gp120 vaccine (50 mcg). Volunteers receive five IM injections at monthly intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, Adjuvants, Immunologic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1 SF-2
Intervention Type
Biological
Intervention Name(s)
MTP-PE/MF59

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Patients must have: Normal history and physical exam. No identifiable high-risk behavior for HIV infection. Negative ELISA for HIV. Normal cell-mediated immune responses using Merieux skin test. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant evidence of depression. Positive syphilis serology (e.g., RPR) that is documented not to be a false positive or from a remote (> 6 months) treated infection. Circulating Hepatitis B antigenemia. More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months. Patients with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. Significant evidence of depression or under treatment for psychiatric problems within the past year. History of anaphylaxis or other adverse vaccine reactions. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) within the past 6 months. Prior Medication: Excluded: Immunoglobulin or vaccines within the past 2 months. Experimental agents within the past 30 days. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 3 months. Risk Behavior: Excluded: History of IV drug use within the past year. More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham B
Official's Role
Study Chair
Facility Information:
Facility Name
St Louis Univ School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Univ of Pennsylvania at Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Univ Hosp
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Children's Hospital & Medical Center / Seattle ACTU
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8678389
Citation
Graham BS, Keefer MC, McElrath MJ, Gorse GJ, Schwartz DH, Weinhold K, Matthews TJ, Esterlitz JR, Sinangil F, Fast PE. Safety and immunogenicity of a candidate HIV-1 vaccine in healthy adults: recombinant glycoprotein (rgp) 120. A randomized, double-blind trial. NIAID AIDS Vaccine Evaluation Group. Ann Intern Med. 1996 Aug 15;125(4):270-9. doi: 10.7326/0003-4819-125-4-199608150-00003.
Results Reference
background
PubMed Identifier
7963729
Citation
Kahn JO, Sinangil F, Baenziger J, Murcar N, Wynne D, Coleman RL, Steimer KS, Dekker CL, Chernoff D. Clinical and immunologic responses to human immunodeficiency virus (HIV) type 1SF2 gp120 subunit vaccine combined with MF59 adjuvant with or without muramyl tripeptide dipalmitoyl phosphatidylethanolamine in non-HIV-infected human volunteers. J Infect Dis. 1994 Nov;170(5):1288-91. doi: 10.1093/infdis/170.5.1288.
Results Reference
background

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Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant

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