Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001046
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
Active Immunization of HIV-Infected Pregnant Women A Phase I Study of Safety and Immunogenicity of a rgp120HIV-1 Vaccine NOTE Some Patients Receive Placebo
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Active Immunization of HIV-Infected Pregnant Women A Phase I Study of Safety and Immunogenicity of a rgp120HIV-1 Vaccine NOTE Some Patients Receive Placebo
Status:
WITHDRAWN
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:
PRIMARY To evaluate the short-term safety of rgp120HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women
SECONDARY To evaluate the immunogenicity and long-term safety of rgp120HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and postpartum To evaluate immunogenicity and safety in the infant through 18 months of age following maternal immunization with the vaccine during pregnancy
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease reduce the titer of virus in maternal plasma and increase the titer of epitope-specific antibody Also active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers
SECONDARY To evaluate the immunogenicity and long-term safety of rgp120HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and postpartum To evaluate immunogenicity and safety in the infant through 18 months of age following maternal immunization with the vaccine during pregnancy
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease reduce the titer of virus in maternal plasma and increase the titer of epitope-specific antibody Also active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers
Detailed Description:
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease reduce the titer of virus in maternal plasma and increase the titer of epitope-specific antibody Also active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers
Women are randomized to receive rgp120HIV-1SF2 vaccine or MF59 placebo Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery for a maximum of five immunizations Patients may continue to receive the immunization regimen to which they were originally assigned at 3 6 9 and 12 months postpartum Maternal follow-up continues until 18 months postpartum infants are followed until age 18 months
Women are randomized to receive rgp120HIV-1SF2 vaccine or MF59 placebo Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery for a maximum of five immunizations Patients may continue to receive the immunization regimen to which they were originally assigned at 3 6 9 and 12 months postpartum Maternal follow-up continues until 18 months postpartum infants are followed until age 18 months
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 |
|---|---|---|---|
| 11210 | REGISTRY | DAIDS ES Registry Number | None |