Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138320
Status:
TERMINATED
Last Update Posted:
2013-09-13
First Post:
2005-08-26
Brief Title:
Herpevac Neonatal Substudy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Transfer of Herpes Simplex Virus Type 2 gD Subunit Vaccine-Induced Antibodies From Mothers to Neonates
Status:
TERMINATED
Status Verified Date:
2013-08
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 to look at the antibodies proteins from the bodys infection fighting system in the blood of babies delivered by women who are participants in the Herpevac Trial for Women and who were vaccinated with either two or three doses of GlaxoSmithKline GSK candidate vaccine gD2talum-MPL or hepatitis A vaccine The goal of this study is to compare the herpes or hepatitis A antibody levels of the newborns to those of their mothers and to see how much of the antibodies are still present in the baby at two and six months after birth Approximately 2 teaspoons 10 ml of the mothers blood will be collected at the time of delivery or within 15 days before or after delivery Approximately 2 teaspoons of blood will be collected from the childs umbilical cord at the time of delivery or 1 teaspoon 3-5 ml of the childs blood will be drawn within 15 days after birth Optional blood draws from babies may occur 2 and 6 months after birth
Detailed Description:
The primary objective of this study is to quantitate HSV-2 binding and neutralizing antibody titers in the sera of newborns delivered by HSV-uninfected women vaccinated with either two or three doses of GSK candidate vaccine gD2talum-MPL and to compare the HSV-2 binding and neutralizing antibody titers of the newborns to those of their mothers Secondary objectives are to 1 evaluate the durability of HSV-2 binding and neutralizing antibody titers in the sera of newborns delivered by HSV-uninfected women vaccinated with either two or three doses of GSK candidate vaccine gD2talum-MPL and 2 quantitate hepatitis A binding antibody titers in the sera of newborns delivered by women vaccinated with either two or three doses of Havrix hepatitis A vaccine the control vaccine used in the Herpevac Trial for Women compare hepatitis A binding antibody titers of the newborns to those of their mothers and evaluate the durability of hepatitis A binding antibodies in these newborns The sample size for this study cannot be determined but based on experience is not likely to be more than 50 women Optional additional blood will be collected from the mother and her infant at 2 mos and 6 mos after delivery
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