The inclusion of pregnant women in vaccine clinical trials: An overview of late-stage clinical trials' records between 2018 and 2023

Maha Salloum; Antea Paviotti; Hilde Bastiaens; Jean-Pierre Van Geertruyden

doi:10.1016/j.vaccine.2023.10.057

The inclusion of pregnant women in vaccine clinical trials: An overview of late-stage clinical trials' records between 2018 and 2023

Vaccine. 2023 Nov 22;41(48):7076-7083. doi: 10.1016/j.vaccine.2023.10.057. Epub 2023 Oct 28.

Authors

Maha Salloum¹, Antea Paviotti², Hilde Bastiaens³, Jean-Pierre Van Geertruyden⁴

Affiliations

¹ Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Drie Eikenstraat 663, 2650 Antwerp, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Doornstraat 331, 2610 Antwerp, Belgium. Electronic address: Maha.Salloum@uantwerpen.be.
² Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Drie Eikenstraat 663, 2650 Antwerp, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Doornstraat 331, 2610 Antwerp, Belgium.
³ Department of Family Medicine and Population Health, University of Antwerp, Doornstraat 331, 2610 Antwerp, Belgium.
⁴ Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Doornstraat 331, 2610 Antwerp, Belgium.

PMID: 37903681
DOI: 10.1016/j.vaccine.2023.10.057

Abstract

Pregnant women are generally excluded from clinical research over safety concerns. However, demands to include them in clinical vaccine development have intensified after recent COVID-19, Ebola, and Lassa fever outbreaks given the disproportionate effect of these diseases on pregnant women and/or their foetuses. Numerous studies highlighted the scarcity of safety data for therapeutic interventions in pregnant women. Nevertheless, only a small number have assessed the number of vaccine trials including this population. Therefore, we searched for phase 3 and 4 vaccine clinical trials in healthy populations registered between 2018 and 2023 in clinicaltrials.gov and the International Clinical Trial Registry Platform. Out of 400 registered vaccine trials matching our inclusion criteria, 217 (54 %) were industry-sponsored, and 222 (56 %) had COVID-19 as a target. We found 22 studies (6 %) that either were designed for pregnant women or included them as part of a larger population. Out of these 22 trials, 13 were designed specifically for pregnant women; seven of these were maternal vaccines aiming at protecting the foetus, namely pertussis (3), Respiratory Syncytial Virus (RSV) (3), and meningitis plus tetanus (1) vaccines, and six others targeted either flu (3), COVID-19 (2) or Ebola (1). Only the RSV and Ebola vaccine trials were industry-sponsored. We also found that nine studies targeting the general population included pregnant women. These focused on COVID-19 (3), flu (2), COVID-19 + flu (2), Ebola (1), and Hepatitis B (1). None of these studies was industry-sponsored. Our findings show that a gap still exists in terms of pregnant women's inclusion in vaccine trials. Such a gap needs to be tackled urgently to minimise the devastating effects that a future infectious disease outbreak could have on this population. This study can inform future demands for increased inclusion, especially in industry-sponsored trials, as it provides an overview of the current vaccine trials scene.

Keywords: COVID-19; Clinical trials; Pharmacovigilance; Pregnancy; Vaccines.

Publication types

Review

MeSH terms

COVID-19* / prevention & control
Ebola Vaccines*
Female
Hemorrhagic Fever, Ebola*
Humans
Pregnancy
Pregnancy Complications, Infectious* / prevention & control
Pregnant Women
Respiratory Syncytial Virus, Human*

Substances

Ebola Vaccines