search
Back to results

Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected Women

Primary Purpose

HIV Infections, HIV Seronegativity

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Aluminum hydroxide
QS-21
MN rsgp120/HIV-1
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 HIV Preventive Vaccine, HIV Therapeutic Vaccine

Eligibility Criteria

1 Day - 3 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria Infants may be eligible for this study if they: Are 1 to 3 days old.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    October 27, 2021
    Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00000809
    Brief Title
    Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected Women
    Official Title
    A Phase I Trial of the Safety and Immunogenicity of MN rsgp120/HIV-1 With the Adjuvants QS-21 and Alum Compared to MN rsgp120/HIV-1 and QS-21 in Infants Born to HIV-Infected Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to test the safety and effectiveness of two different formulations of an HIV vaccine in infants born to HIV-infected women.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, HIV Seronegativity
    Keywords
    HIV Preventive Vaccine, HIV Therapeutic Vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Aluminum hydroxide
    Intervention Type
    Biological
    Intervention Name(s)
    QS-21
    Intervention Type
    Biological
    Intervention Name(s)
    MN rsgp120/HIV-1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    3 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria Infants may be eligible for this study if they: Are 1 to 3 days old.

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected Women

    We'll reach out to this number within 24 hrs