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A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HIV-1 Peptide Vaccine, Microparticulate Monovalent
HIV-1 Peptide Immunogen, Multivalent
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, HIV-1, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

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

Inclusion Criteria Patients must have or be: Healthy. Negative ELISA for HIV. Negative for Hepatitis B surface antigen. Normal urine dipstick. Normal history and physical exam. Availability for follow-up for planned duration of the study (60 weeks). Risk Behavior: Required: Lower or intermediate risk sexual behavior as defined by AVEG. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible. Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible. Patients with any of the following prior conditions are excluded: History of immunodeficiency, chronic illness, malignancy or autoimmune disease. History of anaphylaxis or other serious adverse reactions to vaccines. History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy. History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: History of use of immunosuppressive medication. Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations. Use of experimental agents within 30 days prior to study. Receipt of blood products or immunoglobulin in the past 6 months. Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial. Risk Behavior: Excluded: Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection. History of injection drug use within the last 12 months to enrollment. Higher risk sexual behavior as defined by AVEG.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Univ of Rochester Med Ctr
  • Univ of Washington / Pacific Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000846
Brief Title
A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
Official Title
A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2002
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
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.
Detailed Description
After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.

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, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HIV-1 Peptide Vaccine, Microparticulate Monovalent
Intervention Type
Biological
Intervention Name(s)
HIV-1 Peptide Immunogen, Multivalent

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 or be: Healthy. Negative ELISA for HIV. Negative for Hepatitis B surface antigen. Normal urine dipstick. Normal history and physical exam. Availability for follow-up for planned duration of the study (60 weeks). Risk Behavior: Required: Lower or intermediate risk sexual behavior as defined by AVEG. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible. Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible. Patients with any of the following prior conditions are excluded: History of immunodeficiency, chronic illness, malignancy or autoimmune disease. History of anaphylaxis or other serious adverse reactions to vaccines. History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy. History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: History of use of immunosuppressive medication. Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations. Use of experimental agents within 30 days prior to study. Receipt of blood products or immunoglobulin in the past 6 months. Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial. Risk Behavior: Excluded: Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection. History of injection drug use within the last 12 months to enrollment. Higher risk sexual behavior as defined by AVEG.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mulligan M
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of Washington / Pacific Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.

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