Immunization in pregnancy clinical research in low- and middle-income countries – Study design, regulatory and safety considerations

• DOI: 10.1016/j.vaccine.2017.03.103
• Publication Date: 2017-05-04T22:00:59Z
• Authors: Sonali Kochhar; Jan Bonhoeffer; Christine E. Jones; Flor M. Muñoz; Angel Honrado; Jorgen Bauwens; Ajoke Sobanjo-ter...; Steven Hirschfeld
• Keywords: Research Design; Clinical study design

Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers their infants. Establishing safety efficacy vaccines generally uses hybrid design between conventional interventional study an observational that requires enrolling thousands participants detect unknown number uncommon events. Historically, enrollment in clinical research studies encountered many barriers based on risk aversion, lack knowledge, regulatory ambiguity. Conducting low- middle-income countries can have additional factors address such as limited availability baseline epidemiologic data disease burden maternal neonatal outcomes during after pregnancy; challenges recruiting retaining studies, variability applying interpreting assessment methods, locally acceptable available infrastructure. Some measures these include adjustment design, tailoring recruitment, consent process, retention strategies, operational logistical processes, use definitions collection methods will align with efforts globally.