|
A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers Clinical research trials and A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers. A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers  A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers
A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers
For Condition: HIV Infections,HIV Seronegativity
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.)
Details: 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.]
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: /3 Days
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 48
Location and Contact Information:
Overall Study Official:
JohnLambert, Study Chair,
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Children's Hosp of Orange County
Orange, California, 92868
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Univ Hosp
New Orleans, Louisiana, 70112
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Additional Information:
Study ID Numbers: ACTG 326; PACTG 326
Study Start Date: December 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000879
Other Hiv Infections Studies:
1. BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
2. Preventing Sexual Transmission of HIV With Anti-HIV Drugs
3. HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
4. A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers
5. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers
|
|
|
|
|
|
|
|
