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Obstetrics risk Assessment: Evaluation of selection criteria for vaccine research studies in pregnant women.

Eckert, LO; Jones, CE; Kachikis, A; Bardají, A; Silva, FTD; Absalon, J; Rouse, CE; Khalil, A; Cutland, CL; Kochhar, S; et al. Eckert, LO; Jones, CE; Kachikis, A; Bardají, A; Silva, FTD; Absalon, J; Rouse, CE; Khalil, A; Cutland, CL; Kochhar, S; Munoz, FM (2020) Obstetrics risk Assessment: Evaluation of selection criteria for vaccine research studies in pregnant women. Vaccine, 38 (29). pp. 4542-4547. ISSN 1873-2518 https://doi.org/10.1016/j.vaccine.2020.05.022
SGUL Authors: Jones, Christine Elizabeth Khalil, Asma

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Abstract

Vaccines designed for use in pregnancy and vaccine trials specifically involving pregnant women are rapidly expanding. One of the key challenges in designing maternal immunization trials is that developing exclusion criteria requires understanding and quantifying the background risk for adverse pregnancy outcomes in the pregnancy being studied, which can occur independent of any intervention and be unrelated to vaccine administration. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project has developed and published case definitions and guidelines for data collection, analysis, and evaluation of maternal immunization safety in trials involving pregnant women. Complementing this work, we sought to understand how to best assess obstetric risk of adverse outcomes and differentiate it from the assessment of vaccine safety. Quantification of obstetric risk is based on prior and current obstetric, and maternal medical history. We developed a step-wise approach to evaluate and quantify obstetric and maternal risk factors in pregnancy based on review of published literature and guidelines, and critically assessed these factors in the context of designing inclusion and exclusion criteria for maternal vaccine studies. We anticipate this risk assessment evaluation may assist clinical trialists with study design decisions, including selection of exclusion criteria for vaccine trials involving pregnant women, consideration of sub-group classification, such as high or low risk subjects, or schedule considerations, such as preferred trimester of gestation for an intervention during pregnancy. Additionally, this tool may be utilized in data stratification at time of study analyses.

Item Type: Article
Additional Information: © 2020. This manuscript version is made available under the CC-BY-NC-ND 4.0 license https://creativecommons.org/licenses/by-nc-nd/4.0/
Keywords: Clinical research, Clinical trial, Exclusion criteria, Inclusion criteria, Maternal immunization, Obstetric and neonatal risk factors, Pregnant women, Vaccine, Vaccine safety, Female, Humans, Obstetrics, Patient Selection, Pregnancy, Pregnancy Outcome, Pregnant Women, Vaccines, Humans, Vaccines, Pregnancy Outcome, Obstetrics, Pregnancy, Patient Selection, Pregnant Women, Female, Maternal immunization, Vaccine, Vaccine safety, Obstetric and neonatal risk factors, Clinical trial, Clinical research, Inclusion criteria, Exclusion criteria, Pregnant women, Clinical research, Clinical trial, Exclusion criteria, Inclusion criteria, Maternal immunization, Obstetric and neonatal risk factors, Pregnant women, Vaccine, Vaccine safety, 06 Biological Sciences, 07 Agricultural and Veterinary Sciences, 11 Medical and Health Sciences, Virology
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: Vaccine
ISSN: 1873-2518
Language: eng
Dates:
DateEvent
15 June 2020Published
11 May 2020Published Online
6 May 2020Accepted
Publisher License: Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0
Projects:
Project IDFunderFunder ID
MC_PC_17221Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
MR/R005990/1Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
MR/R005990/2Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
PubMed ID: 32448618
Web of Science ID: WOS:000537560500008
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/113885
Publisher's version: https://doi.org/10.1016/j.vaccine.2020.05.022

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