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Withdrawn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
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Preventive Vaccine, HIV Therapeutic Vaccine
Eligibility Criteria
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
NCT ID
NCT00000809
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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Withdrawn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