Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol.

Area of Science:

• Immunology
• Vaccinology
• Maternal-Fetal Medicine

Background:

• Pregnant women were historically excluded from COVID-19 vaccine trials.
• Limited data exist on COVID-19 vaccine efficacy and safety in pregnant and lactating individuals.

Purpose of the Study:

• To assess the immunogenicity and safety of COVID-19 vaccines in pregnant and lactating women.
• To describe antibody transfer across the placenta and antibody kinetics in mothers and infants.
• To provide a data collection template for future vaccine studies in pregnant populations.

Main Methods:

• Observational, prospective cohort study design.
• Enrollment of approximately 200 pregnant and 65 postpartum women per vaccine formulation.
• Inclusion of women of all ages and medical conditions, with infant follow-up.
• Collection of blood samples for immunogenicity and assessment of pregnancy/birth outcomes.

Main Results:

• Data collection is ongoing; specific results not yet available in this protocol description.
• Descriptive analyses planned by vaccine type and platform.

Conclusions:

• This study protocol addresses the challenges of enrolling pregnant individuals in early vaccine trials.
• It provides a framework for collecting essential data on vaccine response in pregnant and lactating populations.