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NCT00000879 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000879
Other study ID # ACTG 326
Secondary ID PACTG 32610601
Status Completed
Phase Phase 1
First received
Last updated
Est. completion date April 2005

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.)

Description:

Transmission of HIV from an untreated infected mother to her offspring is thought to occur to some infants perinatally and others at parturition. It is possible that administration of an immunogenic vaccine can reduce the vertical transmission of HIV-1 or moderate its course in infected infants. Successful early sensitization to HIV epitopes might succeed in preventing HIV infection. Alternately, the enhancement of HIV-specific immune function might also succeed in modifying HIV replication and affecting disease progression. Sixty infants are treated in this randomized, double-blind study; 45 infants receive recombinant Canarypox virus, ALVAC-HIV vCP205, and 15 receive placebo. Mothers serve as proxy for their infants. All infants receive a minimum of four immunizations, at Weeks 0 (within 72 hours of birth), 4, 8, and 12. Initially, 24 patients are randomized to receive one of two doses of vCP205 or a saline placebo. When a suitable subunit vaccine is available, the protocol will be amended and 36 additional infants will be randomized to receive vCP205 alone or with a subunit vaccine at Weeks 4 and 8 (or vaccine placebo with or without subunit placebo). [AS PER AMENDMENT 11/5/97: 18 infants receive ALVAC-HIV vCP205 at one of two doses and 6 receive placebo.] [AS PER AMENDMENT 9/9/99: Cohort 1 received vCP205. Cohort 2 received a higher dose of vCP205. Cohort A received vCP205 placebo (saline). Cohorts 1, 2, and A were double-blinded and closed to accrual in March 1999. As of September 1999, infants are randomized to one of four new cohorts. Cohort 3 receives vCP1452 at Weeks 0, 4, 8, and 12. Cohort 4 receives vCP1452 at Weeks 0 and 4, then receives vCP1452 plus AIDSVAX B/E gp120 at Weeks 8 and 12. Cohort B receives vCP1452 placebo at Weeks 0, 4, 8, and 12. Cohort C receives vCP1452 placebo at Weeks 0 and 4, then receives vCP1452 placebo plus AIDSVAX B/E placebo at Weeks 8 and 12. All infants are followed every 2 weeks for the first 14 weeks of life, and then every 6 months until age 2. Cord blood is used to establish autologous B cell lines, and CTL assays are performed to characterize the immune response to HIV. In addition, CD4 count, viral load, and mucosal antibody responses are measured. Immunized infants who are not infected with HIV serve as controls for the immunogenicity of the vaccines in the infected infants.] [AS PER AMENDMENT 1/24/00: AIDSVAX B/E has been replaced with AIDSVAX B/B.]

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Days
Eligibility Inclusion Criteria 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. Exclusion Criteria 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ALVAC(2)120(B,MN)GNP (vCP1452)

• MN rgp120/HIV-1 and GNE8 rgp120/HIV-1

• ALVAC-HIV MN120TMG (vCP205)

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

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & 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.

Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. Review. — View Citation

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