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

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: SARS-CoV2 Infection; Pregnancy Related; Vaccine Reaction; Covid19; Immunogenicity

Study type: Observational

Funder types: Other

Identifiers

NCT05115617

CTO 3612

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women/Individuals ≥ 16 years of age who are ≥7 0/7 weeks' gestation on the day of enrollment
• Capacity to provide informed consent and to comprehend and comply with the study requirements
• Planning to deliver at a participating site hospital
• Planning to receive or have previously received one-dose of a Health Canada approved COVID-19 vaccine (any product, any number of doses) during the current pregnancy

Exclusion criteria

• Cases with known major fetal concerns
• Women/Individuals who are fully vaccinated against COVID-19
• Women/Individuals who are pregnant due to surrogacy, or planning to give their child up for adoption
• Women/Individuals with a non-viable pregnancy (e.g., ectopic)

Trial design

150 participants in 1 patient group

Pregnant individuals

Description:

Pregnant individuals who have previously received one-dose of COVID-19 vaccine, or who are planning to receive a COVID-19 vaccine in pregnancy.