Vaccination In Pregnancy Gene Signature: VIP Signature Study

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Vaccination
• Intervention / Treatment: Biological: Vaccination with a pertussis containing vaccine

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW170RE
    • St George's, University of London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All women; Women who are between 16-32 weeks gestation and who have not previously received a pertussis vaccination in pregnancy.	Biological: Vaccination with a pertussis containing vaccine; Vaccination with a pertussis containing vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression profiles	Gene expression profiles in blood samples from pregnant women following vaccination.	24 hours

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: Max Planck Institute for Infection Biology; Innovative Medicine Initiative

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): March 21, 2018

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 17.0060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No