A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers
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| ClinicalTrials.gov Identifier: NCT00000879 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : May 18, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections HIV Seronegativity | Biological: ALVAC(2)120(B,MN)GNP (vCP1452) Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 Biological: ALVAC-HIV MN120TMG (vCP205) | Phase 1 |
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.]
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 48 participants |
| Masking: | Double |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Completion Date : | April 2005 |
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| Ages Eligible for Study: | up to 3 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000879
| United States, California | |
| Long Beach Memorial Med. Ctr., Miller Children's Hosp. | |
| Long Beach, California, United States, 90801 | |
| Children's Hosp. of Orange County | |
| Orange, California, United States, 92868 | |
| UCSF Pediatric AIDS CRS | |
| San Francisco, California, United States | |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | |
| Torrance, California, United States | |
| United States, Illinois | |
| Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program | |
| Chicago, Illinois, United States, 60608 | |
| Chicago Children's CRS | |
| Chicago, Illinois, United States | |
| United States, Louisiana | |
| Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic | |
| New Orleans, Louisiana, United States | |
| United States, Maryland | |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | |
| Boston, Massachusetts, United States | |
| WNE Maternal Pediatric Adolescent AIDS CRS | |
| Worcester, Massachusetts, United States | |
| United States, New York | |
| Jacobi Med. Ctr. Bronx NICHD CRS | |
| Bronx, New York, United States, 10461 | |
| Nyu Ny Nichd Crs | |
| New York, New York, United States, 10016 | |
| Columbia IMPAACT CRS | |
| New York, New York, United States, 10032 | |
| SUNY Upstate Med. Univ., Dept. of Peds. | |
| Syracuse, New York, United States, 13210 | |
| United States, Pennsylvania | |
| Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| The Children's Hosp. of Philadelphia IMPAACT CRS | |
| Philadelphia, Pennsylvania, United States | |
| United States, Washington | |
| Seattle Children's Hospital CRS | |
| Seattle, Washington, United States | |
| Study Chair: | John Lambert | ||
| Study Chair: | Daniel Johnson | ||
| Study Chair: | Stuart Starr |
Publications of Results:
Other Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000879 History of Changes |
| Other Study ID Numbers: |
ACTG 326 PACTG 326 10601 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | May 18, 2012 |
| Last Verified: | May 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Pregnancy Pregnancy Complications, Infectious AIDS Vaccines Disease Transmission, Vertical |
Avipoxvirus HIV Preventive Vaccine HIV Therapeutic Vaccine |
Additional relevant MeSH terms:
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HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |