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

March 5, 2024 updated by: Darine El-Chaâr, Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephanie Boyd, MBA
  • Phone Number: 77295 613-737-8899
  • Email: sboyd@ohri.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 8E7
        • Not yet recruiting
        • Hamilton Health Sciences Corporation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarah McDonald, MD
      • Kingston, Ontario, Canada, K7L 2V7
      • London, Ontario, Canada, N6A 5W9
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • The Ottawa Hospital - General
        • Contact:
          • Stephanie Boyd, MBA
          • Phone Number: 77295 613-737-8899
          • Email: sboyd@ohri.ca
        • Contact:
        • Principal Investigator:
          • Darine El-Chaâr, MD, MSc
        • Sub-Investigator:
          • Marc-Andre Langlois, PhD
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Recruiting
        • The Ottawa Hospital - Civic Campus
        • Contact:
          • Stephanie Boyd, MBA
          • Phone Number: 77295 613-737-8899
          • Email: sboyd@ohri.ca
        • Contact:
        • Principal Investigator:
          • Jessica Dy, MD
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5B 1W8
        • Not yet recruiting
        • St. Michael's Hospital
        • Contact:
        • Contact:
          • Arifa Rahman, M.B.B.S, MPH
          • Phone Number: arifa.rahman@unityhealth.to
        • Principal Investigator:
          • Howard Berger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody titres in biological samples
Time Frame: 1-month post COVID-19 vaccine
Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period.
1-month post COVID-19 vaccine
Antibody titres in biological samples
Time Frame: 3-month, and 6-month post COVID-19 vaccine
Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period.
3-month, and 6-month post COVID-19 vaccine
Antibody titres in biological samples
Time Frame: 6-month post COVID-19 vaccine
Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period.
6-month post COVID-19 vaccine
Antibody titres in biological samples
Time Frame: At delivery
Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period.
At delivery
Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
Time Frame: 6-months post-COVID-19 vaccine
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
6-months post-COVID-19 vaccine
Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
Time Frame: 3-month post-COVID-19 vaccine
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
3-month post-COVID-19 vaccine
Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
Time Frame: 1-month post-COVID-19 vaccine
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
1-month post-COVID-19 vaccine
Antibody titres in biological samples of pregnant and non-pregnant populations
Time Frame: During delivery admission
Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns
During delivery admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal death
Time Frame: through study completion, an average of 9 months
Maternal death during delivery admission
through study completion, an average of 9 months
Maternal - Non-delivery hospitalization
Time Frame: through study completion, an average of 9 months)
Any hospitalization not associated with the delivery of infant.
through study completion, an average of 9 months)
Any infection
Time Frame: through study completion, an average of 9 months
Maternal diagnosis of any infection during pregnancy
through study completion, an average of 9 months
Pre-term labour
Time Frame: through study completion, an average of 9 months
The onset of labour prior to 37 weeks gestation
through study completion, an average of 9 months
Hypertensive disorders of pregnancy
Time Frame: through study completion, an average of 9 months
The diagnosis of a hypertensive disorder of pregnancy
through study completion, an average of 9 months
Placental abruption
Time Frame: through study completion, an average of 9 months
The diagnosis of placental abruption during pregnancy
through study completion, an average of 9 months
Postpartum hemorrhage
Time Frame: Post-delivery, during the delivery admission
The diagnosis of postpartum hemorrhage
Post-delivery, during the delivery admission
Preterm birth
Time Frame: through study completion, an average of 9 months
Infant born prior to 37 weeks gestation
through study completion, an average of 9 months
Fetal loss or stillbirth
Time Frame: through study completion, an average of 9 months
Fetal loss or stillbirth throughout the pregnancy
through study completion, an average of 9 months
Small for gestational age
Time Frame: During the pregnancy, through study completion, an average of 9 months
<10th percentile for gestational age and sex- specific birth weight
During the pregnancy, through study completion, an average of 9 months
Term low birthweight
Time Frame: At delivery
<2500g
At delivery
Low 5 min Apgar Score
Time Frame: At delivery
Score <5 at 5 minutes
At delivery
Low cord blood pH
Time Frame: At delivery
cord blood pH<7.0
At delivery
admission to neonatal ICU for >12 hours
Time Frame: During delivery admission
Infant admission to the neonatal ICU for >12 hours
During delivery admission
composite neonatal adverse outcome indicator [NAOI]
Time Frame: At delivery
A composite indicator which includes various neonatal adverse outcomes
At delivery
Frequency of infection
Time Frame: Postpartum, through study completion, an average of 9 months
Number of infections, including but not limited to: influenza, pneumonia, sepsis, acute respiratory infections, gastrointestinal
Postpartum, through study completion, an average of 9 months
Re-hospitalization rates
Time Frame: Postpartum, through study completion, an average of 9 months
Number of re-hospitalizations and emergency visits
Postpartum, through study completion, an average of 9 months
Composite indicator for complex chronic conditions
Time Frame: Postpartum, through study completion, an average of 9 months
Composite indicator includes: neurologic and neuromuscular; cardiovascular; respiratory; renal and urologic; gastrointestinal; hematologic or immunologic; metabolic; other congenital or genetic defect; and malignancy
Postpartum, through study completion, an average of 9 months
Infant death
Time Frame: Postpartum, through study completion, an average of 9 months
Infant death
Postpartum, through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)
University of Ottawa
Children's Hospital of Eastern Ontario Research Institute

Investigators

  • Principal Investigator: Darine El-Chaâr, MD, MSc, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO 3612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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