NCT00000879

Brief Summary

The purpose of this study is to see if giving the ALVAC vCP1452 anti-HIV vaccine alone or with another vaccine called AIDSVAX B/B to babies of HIV-positive mothers is safe. The study will also look at how these vaccines affect a baby's immune system. Most HIV-positive children get HIV from their mothers during pregnancy or birth. Treatment with anti-HIV drugs can reduce the baby's risk of getting HIV. Vaccines also may help prevent HIV infection. This study will look at whether the ALVAC vCP1452 vaccine and the AIDSVAX B/B vaccine can help the body fight off HIV infection. There is no chance of getting HIV infection from the vaccines. (This study has been changed. In earlier versions, ALVAC vCP205 and AIDSVAX B/E were going to be used.)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV InfectionsHIV Seronegativity

Keywords

PregnancyPregnancy Complications, InfectiousAIDS VaccinesDisease Transmission, VerticalAvipoxvirusHIV Preventive VaccineHIV Therapeutic Vaccine

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452)BIOLOGICAL
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1BIOLOGICAL
ALVAC-HIV MN120TMG (vCP205)BIOLOGICAL

Eligibility Criteria

Age0 Days - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The infant may be eligible if the mother:
  • Is HIV-positive.
  • Is willing to follow the study guidelines.
  • Had her baby at Week 37 of pregnancy or later.

You may not qualify if:

  • The infant will not be eligible if the mother:
  • Has hepatitis B.
  • Is breast-feeding her baby.
  • Used certain medications during pregnancy.
  • The infant will not be eligible if he/she:
  • Is more than 3 days old at study entry.
  • Has a serious infection or life-threatening illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, 90801, United States

Location

Children's Hosp. of Orange County

Orange, California, 92868, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, United States

Location

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, United States

Location

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

Chicago, Illinois, 60608, United States

Location

Chicago Children's CRS

Chicago, Illinois, United States

Location

Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic

New Orleans, Louisiana, United States

Location

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, 21201, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Jacobi Med. Ctr. Bronx NICHD CRS

The Bronx, New York, 10461, United States

Location

Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, United States

Location

Seattle Children's Hospital CRS

Seattle, Washington, United States

Location

Related Publications (2)

  • Johnson D, McFarland E, Muresan P, Fenton T, Lambert J, McNamara J, Hawkins E, Bouquin P, Read J, Estep S, Gunurathan S, Gurwith M, PACTG 326 Protocol Team. PACTG 326: A Phase I/II Study to Evaluate the Safety and Immunogenicity of Alvac HIV Vaccines Alone and with AIDSVax B/B in Children Born to HIV-infected Mothers: Preliminary Results. 10th Conference on Retroviruses and Oppurtunistic Infections. Feb 2003. Abstract 404.

    BACKGROUND

  • Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001.

    PMID: 16220994RESULT

MeSH Terms

Conditions

HIV InfectionsPregnancy Complications, Infectious

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • John Lambert

    STUDY CHAIR

  • Daniel Johnson

    STUDY CHAIR

  • Stuart Starr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

April 1, 2005

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(17)