Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03284515
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2017-09-13
Brief Title:
Vaccination In Pregnancy Gene Signature VIP Signature Study
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
Vaccination In Pregnancy Gene Signature VIP Signature Study
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None