Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001041
Status:
COMPLETED
Last Update Posted:
2021-11-01
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 MN 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-1 Infected Pregnant Women With CD4 Lymphocyte Counts 400mm3 A Phase I Study of Safety and Immunogenicity of MN rgp120HIV-1 Vaccine 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 rgp120HIV-1MN vaccine 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 To evaluate the induction or augmentation by rgp120HIV-1MN vaccine of mucosal immune response in the gastrointestinal and reproductive tracts during pregnancy To isolate and genetically characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and compare it to that present in their peripheral blood mononuclear cells and to that of their infected 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 MN rgp120 vaccine 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 Per 0694 addendum patients will be contacted once or twice per year for at least 5 years to check on health status of patient and child PER 122194 ADDENDUM post-partum immunizations are discontinued
Pregnant women are randomized to receive an initial injection of MN rgp120 vaccine 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 Per 0694 addendum patients will be contacted once or twice per year for at least 5 years to check on health status of patient and child PER 122194 ADDENDUM post-partum immunizations are discontinued
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 |
|---|---|---|---|
| 11212 | REGISTRY | DAIDS ES Registry Number | None |
| AVEG 104 | None | None | None |