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Vaccination In Pregnancy Gene Signature: VIP Signature Study

Vaccination In Pregnancy Gene Signature: VIP Signature Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03284515
Enrollment
30
Registered
2017-09-15
Start date
2017-09-07
Completion date
2018-03-21
Last updated
2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related, Vaccination

Brief summary

A study investigating gene expression profiles in pregnant women in response to a pertussis containing vaccination in pregnancy.

Detailed description

Vaccinations are a vital part of ensuring population health, but there is a continued need for new and improved vaccines to be developed and this process of design and development can be both slow and expensive. Vaccination in pregnancy against pathogens such as pertussis, influenza and tetanus is a routine part of antenatal care in many countries. The principle behind this approach is that through vaccination the amount of disease specific antibody is increased in the woman and there is therefore an increase in transplacental transfer to the fetus providing protection for infants after birth. In the UK vaccination against pertussis is recommended from 16 weeks gestation and against influenza at any gestation within the influenza season. There is evidence that pertussis vaccination in pregnancy is highly effective against pertussis in infants too young to be protected by the routine infant immunisation programme (Amirthalingam G et al, 2014, Dabrera G et al, 2015). There is also evidence that this is a safe strategy in pregnancy to protect newborn infants (Donegan K et al, 2014) with no evidence of adverse clinical outcomes for mother or infant. The BioVacSafe project has been designed to develop techniques which can be used to understand more about biomarkers of safety in individuals' response to vaccines. This will improve our understanding of how reactogenicity can be identified earlier, how adverse reactions can be identified and classified and how individuals interact with vaccines, specifically in conditions of health and disease. Since the start of the BioVacSafe project the importance of vaccination in pregnancy has become better understood and it has become important to include pregnant women as participants in this project. Pregnancy is a time of altered immunity and it may be that there are differences in gene signatures following vaccination in pregnant women compared with non-pregnant women. Insights into this could be extremely important in the development of new vaccines for this population. Safety of vaccination in pregnancy is of primary importance to pregnant women and their partners, clinical trials investigators, ethics committees, vaccine manufacturers and regulators. Determining specific genetic signatures following vaccination may accelerate vaccine development by predicting possible adverse events early in the development process.

Interventions

BIOLOGICALVaccination with a pertussis containing vaccine

Vaccination with a pertussis containing vaccine

Sponsors

Innovative Medicine Initiative
CollaboratorUNKNOWN
Max Planck Institute for Infection Biology
CollaboratorOTHER
St George's, University of London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Having received a pertussis containing vaccine within the last 12 months * Contraindications to vaccination according to the green book

Design outcomes

Primary

MeasureTime frameDescription
Gene expression profiles24 hoursGene expression profiles in blood samples from pregnant women following vaccination.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026