A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers

Completed · Phase 1

Conditions studied: HIV Infections, HIV Seronegativity

In brief

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.)

Key facts

Study ID

NCT00000879

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Expected to finish

2005-04-01

Last updated by the study team

2021-10-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Children's Hosp. of Orange County — Orange, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic — New Orleans, Louisiana, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Columbia IMPAACT CRS — New York, New York, United States
• SUNY Upstate Med. Univ., Dept. of Peds. — Syracuse, New York, United States
• Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
• Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Children's Hosp. of Philadelphia IMPAACT CRS — Philadelphia, Pennsylvania, United States
• Seattle Children's Hospital CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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