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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00000809

First received: November 2, 1999

Last updated: May 16, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	May 16, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00000809 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected Women
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Primary Purpose: Prevention
Condition ^ICMJE	HIV Infections HIV Seronegativity
Intervention ^ICMJE	Biological: Aluminum hydroxide Biological: QS-21 Biological: MN rsgp120/HIV-1
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria Infants may be eligible for this study if they: Are 1 to 3 days old.
Gender	Both
Ages	up to 3 Days
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00000809
Other Study ID Numbers ^ICMJE	ACTG 279, 11255
Has Data Monitoring Committee	Not Provided
Responsible Party	National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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