Herpevac Neonatal Substudy
Transfer of Herpes Simplex Virus Type 2 gD Subunit Vaccine-Induced Antibodies From Mothers to Neonates
1 other identifier
observational
6
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2005
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 26, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedSeptember 13, 2013
August 1, 2013
1.7 years
August 26, 2005
September 12, 2013
Conditions
Keywords
Eligibility Criteria
Women who become pregnant while enrolled as participants in the Herpevac Trial for Women, DMID Protocol 01-643
You may qualify if:
- Enrolled in the Herpevac Trial for Women.
- Has received at least two doses of either the candidate or control vaccine.
- Pregnant.
- Written informed consent obtained from the participant.
- Willing to have her blood collected either at the time of delivery or within 15 days before or after delivery. If blood is to be collected by the health care provider who will be presiding at the delivery, the participant must be willing to give permission for study personnel to contact that health care provider to arrange the collection of blood.
- Willing to have either umbilical vein blood collected at the time of delivery or blood collected from her neonate within 15 days after delivery. If blood is to be collected from the umbilical vein, the participant must be willing to give permission for study personnel to contact the presiding health care provider to arrange the collection of blood.
- A participant whom the investigator believes can and will comply with the requirements of the protocol.
You may not qualify if:
- Termination of the pregnancy, other than live birth.
- Entry violation in the Herpevac Trial for Women at enrollment.
- Receipt of immunoglobulin or blood products within 4 months prior to expected date of delivery.
- History or current clinical evidence of herpes simplex virus infection.
- Maternal withdrawal criteria: If any of the following occur after enrollment, the subject will be withdrawn prior to obtaining any blood samples:
- Termination of the pregnancy, other than live birth.
- Determination that the subject was enrolled in the Herpevac Trial for Women in violation of that study's entry criteria.
- Receipt of immunoglobulin or blood products within 4 months prior to expected or actual date of delivery.
- Inability to collect umbilical vein blood at the time of delivery or neonatal blood within 15 days after birth due to logistical or other reasons.
- Infant withdrawal criteria: If any of the following occurs during the study, the 2 and 6-month blood samples (or the 6-month sample only if the occurrence follows the 2-month blood draw) will not be collected from the infant:
- Participant \[mother\] chooses not to participate, or continue her participation in, the optional arm of the study.
- Inability to collect neonatal blood within 15 days after birth due to logistical or other reasons from infants for whom umbilical vein blood was not collected.
- Death of the infant.
- Adoption of the infant prior to completion of the study.
- At the discretion of the investigator.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Saint Louis University
St Louis, Missouri, 63110, United States
University of Rochester
Rochester, New York, 14642, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Biospecimen
Sera obtained from collected blood samples will be used. Ten mL of blood will be collected at the maternal blood draw and from the umbilical vein. Three to 5 mL of blood will be collected at each infant blood draw
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2005
First Posted
August 30, 2005
Study Start
August 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
September 13, 2013
Record last verified: 2013-08