Clinical Trials Logo

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03284515
Study type Observational
Source St George's, University of London
Status Completed
Start date September 7, 2017
Completion date March 21, 2018

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT04960800 - Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis N/A
Completed NCT03188250 - Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya N/A
Recruiting NCT03671109 - Improving Maternal heAlth by Reducing Malaria in African HIV Women Phase 3
Recruiting NCT03855735 - Communication and Patient Safety in Gynecology and Obstetrics - Study Protocol of an Intervention Study N/A
Active, not recruiting NCT03679130 - FitMum: Fitness for Good Health of Mother and Child N/A
Completed NCT03687879 - Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
Recruiting NCT04568044 - Evaluation of Humoral Immunity Following COVID-19 in Pregnancy
Recruiting NCT04572178 - Cash Payment and Counseling During Pregnancy N/A
Recruiting NCT04079959 - Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in IVF-ET
Recruiting NCT04326322 - Methionine Requirements During Healthy Human Pregnancy N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Completed NCT04146025 - Nurtured in Nature N/A
Recruiting NCT04918524 - The Clinical Features and Pregnancy Outcomes of CTD Patients
Recruiting NCT04976465 - Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
Not yet recruiting NCT04978064 - E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV) N/A
Not yet recruiting NCT04939012 - Repro Health, Implementation Patient-centered, Reproductive Planning Decision Support Tool (MyPath) N/A
Not yet recruiting NCT04925765 - Virtual Reality Biofeedback for Postpartum Anxiety and Depression N/A
Recruiting NCT04374773 - Effects of Pregnancy-associated Hormones on THC Metabolism in Women Phase 4