NCT00138320

Herpevac Neonatal Substudy

Transfer of Herpes Simplex Virus Type 2 gD Subunit Vaccine-Induced Antibodies From Mothers to Neonates

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study to look at the antibodies (proteins from the body's 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 gD2t/alum-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 mother's 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 child's umbilical cord at the time of delivery, or 1 teaspoon (3-5 ml) of the child's 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 gD2t/alum-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 gD2t/alum-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.

Conditions

• Herpes Simplex

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-08-30
• Last updated: 2013-09-13

Locations

5 sites across 1 country: United States