NCT05115617

Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study

Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The PLAN-V Study is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals, who have received the COVID-19 vaccine during their pregnancy, and their infants across the antenatal, delivery and postpartum periods.

Detailed description

There is a pressing need for research to answer critical questions about the role of maternal vaccination for protection of the mother-infant dyad, to inform public health recommendations and to support evidence-based decision-making by Canadian families and their care providers. The investigators' goal is to generate rapid, reliable evidence specific to the immunogenicity and safety of COVID-19 vaccines in the pregnant population. The specific PLAN-V Study objectives are: 1. To evaluate immunogenicity of COVID-19 vaccines in pregnant women/individuals and the fetal/newborn immune response to maternal vaccination. 2. To evaluate safety of COVID-19 vaccination in pregnant women/individuals based on obstetrical, fetal and newborn health outcomes. 3. To compare immune responses to COVID-19 vaccination and natural COVID-19 disease among pregnant women/individuals and their infants exposed in utero 4. To compare the immune responses to COVID-19 vaccination between pregnant and non-pregnant women/individuals. PLAN-V is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals and their infants across the prenatal, delivery and postpartum periods. With this approach, detailed participant profiles will be generated that will enable us to explore vaccine reactogenicity; vaccine-associated adverse events; frequency of obstetrical and fetal/newborn outcomes; and measures of infant health and well-being. The study will build on existing resources and expertise available through the COVID-19 Ontario Pregnancy Event (COPE) Network to establish a prospective, longitudinal cohort study of pregnant women/individuals, and their infants. The PLAN-V Study will consist of pregnant women/individuals who are planning to receive a COVID-19 vaccine(s) at any stage in pregnancy.

Conditions

• SARS-CoV2 Infection
• Covid19
• Vaccine Reaction
• Pregnancy Related
• Immunogenicity

Timeline

• Start date: 2021-06-03
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2021-11-10
• Last updated: 2024-03-07

Locations

7 sites across 1 country: Canada