Vaccination In Pregnancy Gene Signature: VIP Signature Study

Pregnancy Related Clinical Trial

Official title:

Vaccination In Pregnancy Gene Signature: VIP Signature Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284515
• Other study ID #: 17.0060
• Status: Completed
• Start date: September 7, 2017
• Est. completion date: March 21, 2018

Study information

• Verified date: January 2021
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 21, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Vaccination

Intervention

Biological:
• Vaccination with a pertussis containing vaccine
Vaccination with a pertussis containing vaccine

Locations

Country	Name	City	State
United Kingdom	St George's, University of London	London

Sponsors (3)

Lead Sponsor	Collaborator
St George's, University of London	Innovative Medicine Initiative, Max Planck Institute for Infection Biology

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression profiles	Gene expression profiles in blood samples from pregnant women following vaccination.	24 hours