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

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    Ottawa Hospital Research Institute
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Updated on 14 March 2022
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Accepts healthy volunteers

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.

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.

Details
Condition SARS-CoV2 Infection, Covid19, Vaccine Reaction, Pregnancy Related, Immunogenicity
Clinical Study IdentifierNCT05115617
SponsorOttawa Hospital Research Institute
Last Modified on14 March 2022

Eligibility

 Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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