Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000879
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study to Evaluate the Safety and Immunogenicity of ALVAC HIV Vaccines Alone and With AIDSVAX BB in Children Born to HIV-Infected Mothers
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BB to babies of HIV-positive mothers is safe The study will also look at how these vaccines affect a babys immune system Most HIV-positive children get HIV from their mothers during pregnancy or birth Treatment with anti-HIV drugs can reduce the babys risk of getting HIV Vaccines also may help prevent HIV infection This study will look at whether the ALVAC vCP1452 vaccine and the AIDSVAX BB 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 BE were going to be used
Detailed 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 11597 18 infants receive ALVAC-HIV vCP205 at one of two doses and 6 receive placebo AS PER AMENDMENT 9999 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 BE 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 BE 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 12400 AIDSVAX BE has been replaced with AIDSVAX BB
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 11597 18 infants receive ALVAC-HIV vCP205 at one of two doses and 6 receive placebo AS PER AMENDMENT 9999 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 BE 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 BE 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 12400 AIDSVAX BE has been replaced with AIDSVAX BB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10601 | REGISTRY | DAIDS ES Registry Number | None |
| PACTG 326 | None | None | None |