Clinical trial NCT03284515: Vaccination In Pregnancy Gene Signature: VIP Signature Study
Official title: Vaccination In Pregnancy Gene Signature: VIP Signature Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Vaccination
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Innovative Medicine Initiative
name: Max Planck Institute for Infection Biology
First posted: 2017-09-15
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at between 16-32 weeks gestation who have not yet received the pertussis vaccination in pregnancy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gene expression profiles
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's, University of London
Study officials:
References: