Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000777
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Active Immunization of HIV-1 Infected Pregnant Women With CD4 Lymphocyte Counts 400mm3 A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 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-1 Infected Pregnant Women With CD4 Lymphocyte Counts 400mm3 A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 NOTE Some Patients Receive Placebo
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:
To evaluate the safety of gp160 vaccine VaxSyn in HIV-1 infected pregnant women with CD4 counts 400 cellsmm3 To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus Slowing the progression of disease reducing the titer of virus in plasma and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus Slowing the progression of disease reducing the titer of virus in plasma and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy
Detailed Description:
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus Slowing the progression of disease reducing the titer of virus in plasma and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy
Pregnant women are randomized to receive an initial injection of VaxSyn or alum placebo between week 16 and week 24 of gestation followed by monthly booster injections concluding at the end of pregnancy for a total of five injections Patients may have optional booster immunizations vaccine or placebo at 3 6 9 and 12 months after delivery Mothers and infants are followed through 18 months after delivery
Pregnant women are randomized to receive an initial injection of VaxSyn or alum placebo between week 16 and week 24 of gestation followed by monthly booster injections concluding at the end of pregnancy for a total of five injections Patients may have optional booster immunizations vaccine or placebo at 3 6 9 and 12 months after delivery Mothers and infants are followed through 18 months after delivery
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11211 | REGISTRY | DAIDS ES Registry Number | None |
| VEU 102 | None | None | None |