Herpes SimplexNCT00138320
Herpevac Neonatal Substudy
An observational study of Herpes Simplex, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex
- How many people
- 6 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2005to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Women who become pregnant while enrolled as participants in the Herpevac Trial for Women, DMID Protocol 01-643
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Receipt of immunoglobulin or blood products by the infant prior to blood draw.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84132
Saint Louis University
St Louis, Missouri, 63110
About this study
Official title: Transfer of Herpes Simplex Virus Type 2 gD Subunit Vaccine-Induced Antibodies From Mothers to Neonates
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.
Read the 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
- Keywords
- Herpes Simplex, vaccine, antibodies, mother
- Medical subject headings
- Herpes Simplex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138320
- Sponsor's protocol ID
- 04-041
- Status last verified
- Aug 2013
- First submitted
- 26 Aug 2005
- Last updated
- 13 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Herpes Simplex Virus Type 2 gD Subunit Vaccine-Induced Antibodies From Mothers to Neonates
- ClinicalTrials.gov ID
- NCT00138320
- Acronym / sponsor ID
- 04-041
- Conditions
- Herpes Simplex
- Keywords
- Herpes Simplex, vaccine, antibodies, mother
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women who become pregnant while enrolled as participants in the Herpevac Trial for Women, DMID Protocol 01-643
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Simplex, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.