search
Back to results

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59

Primary Purpose

HIV Infections, HIV Seronegativity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Env 2-3
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, Drug Evaluation, Adjuvants, Immunologic, AIDS Vaccines, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Subjects are: Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study. Exclusion Criteria Co-existing Condition: Subjects with the following conditions or symptoms are excluded: Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment. Circulating hepatitis B antigenemia. Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, or autoimmune disease. Evidence of depression or under treatment for psychiatric problems during the past year. Prior Medication: Excluded: Immunosuppressive medications. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection, including: history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.

Sites / Locations

  • Univ. of Rochester AVEG
  • Vanderbilt Univ. Hosp. AVEG
  • UW - Seattle AVEG

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Biocine
search

1. Study Identification

Unique Protocol Identification Number
NCT00000632
Brief Title
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Official Title
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1992 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Biocine

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365. Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.
Detailed Description
Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest. Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Env 2-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Subjects are: Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study. Exclusion Criteria Co-existing Condition: Subjects with the following conditions or symptoms are excluded: Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment. Circulating hepatitis B antigenemia. Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, or autoimmune disease. Evidence of depression or under treatment for psychiatric problems during the past year. Prior Medication: Excluded: Immunosuppressive medications. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection, including: history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolin R
Official's Role
Study Chair
Facility Information:
Facility Name
Univ. of Rochester AVEG
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Vanderbilt Univ. Hosp. AVEG
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UW - Seattle AVEG
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9486388
Citation
Evans TG, Fitzgerald T, Gibbons DC, Keefer MC, Soucier H. Th1/Th2 cytokine responses following HIV-1 immunization in seronegative volunteers. The AIDS Vaccine Evaluation Group. Clin Exp Immunol. 1998 Feb;111(2):243-50. doi: 10.1046/j.1365-2249.1998.00486.x.
Results Reference
background
PubMed Identifier
8744579
Citation
Keefer MC, Graham BS, McElrath MJ, Matthews TJ, Stablein DM, Corey L, Wright PF, Lawrence D, Fast PE, Weinhold K, Hsieh RH, Chernoff D, Dekker C, Dolin R. Safety and immunogenicity of Env 2-3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1996 May 20;12(8):683-93. doi: 10.1089/aid.1996.12.683.
Results Reference
background

Learn more about this trial

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59

We'll reach out to this number within 24 hrs