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A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HIV-1 Peptide Vaccine, Microparticulate Monovalent
rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine
Sponsored by
United Biomedical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity

Eligibility Criteria

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

Inclusion Criteria Volunteers must have: Normal history and physical exam. HIV negativity. CD4 count >= 400 cells/mm3. Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry. Normal urine dipstick with esterase and nitrite. Exclusion Criteria Co-existing Condition: Volunteers with the following symptoms or conditions are excluded: Active tuberculosis. Occupational or other responsibilities that would prevent completion of study. Volunteers with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study. History of anaphylaxis or other serious adverse reactions to vaccines. History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy. Acute gastroenteritis or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: Live or attenuated vaccine within the past 60 days. Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.

Sites / Locations

  • Univ of California at San Francisco Gen Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
United Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT00002428
Brief Title
A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
Official Title
A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
United Biomedical

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.
Detailed Description
Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are followed for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HIV-1 Peptide Vaccine, Microparticulate Monovalent
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine

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 Volunteers must have: Normal history and physical exam. HIV negativity. CD4 count >= 400 cells/mm3. Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry. Normal urine dipstick with esterase and nitrite. Exclusion Criteria Co-existing Condition: Volunteers with the following symptoms or conditions are excluded: Active tuberculosis. Occupational or other responsibilities that would prevent completion of study. Volunteers with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study. History of anaphylaxis or other serious adverse reactions to vaccines. History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy. Acute gastroenteritis or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: Live or attenuated vaccine within the past 60 days. Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.
Facility Information:
Facility Name
Univ of California at San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11311997
Citation
Lambert JS, Keefer M, Mulligan MJ, Schwartz D, Mestecky J, Weinhold K, Smith C, Hsieh R, Moldoveanu Z, Fast P, Forrest B, Koff W. A Phase I safety and immunogenicity trial of UBI microparticulate monovalent HIV-1 MN oral peptide immunogen with parenteral boost in HIV-1 seronegative human subjects. Vaccine. 2001 Apr 30;19(23-24):3033-42. doi: 10.1016/s0264-410x(01)00051-2.
Results Reference
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A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

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