Vaccination In Pregnancy Gene Signature: VIP Signature Study
1 other identifier
observational
30
1 country
1
Brief Summary
A study investigating gene expression profiles in pregnant women in response to a pertussis containing vaccination in pregnancy.
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 Sep 2017
Shorter than P25 for all trials
1 active site
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
September 7, 2017
CompletedFirst Submitted
Initial submission to the registry
September 13, 2017
CompletedFirst Posted
Study publicly available on registry
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2018
CompletedJanuary 11, 2021
January 1, 2021
5 months
September 13, 2017
January 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Gene expression profiles
Gene expression profiles in blood samples from pregnant women following vaccination.
24 hours
Study Arms (1)
All women
Women who are between 16-32 weeks gestation and who have not previously received a pertussis vaccination in pregnancy.
Interventions
Vaccination with a pertussis containing vaccine
Eligibility Criteria
Pregnant women at between 16-32 weeks gestation who have not yet received the pertussis vaccination in pregnancy.
You may qualify if:
- Pregnant at a gestation of 16-32 weeks
- No contraindications to vaccination according to the green book
- No known immunodeficiency
- Able to understand the details of the study and willing to provide informed consent
You may not qualify if:
- Having received a pertussis containing vaccine within the last 12 months
- Contraindications to vaccination according to the green book
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St George's, University of Londonlead
- Innovative Medicine Initiativecollaborator
- Max Planck Institute for Infection Biologycollaborator
Study Sites (1)
St George's, University of London
London, SW170RE, United Kingdom
Biospecimen
Blood samples will be taken from the women prior to and 24 hours following vaccination.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2017
First Posted
September 15, 2017
Study Start
September 7, 2017
Primary Completion
January 31, 2018
Study Completion
March 21, 2018
Last Updated
January 11, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share
Personal details of the participants will be collected to allow us to contact them if necessary. This information will be stored securely and will not leave St. George's, University of London. Some limited demographic and medical information may be shared with researchers at Imperial College London and the Max Planck Institute for Infection Biology both of which are part of this study and the wider BioVacSafe consortium.