Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study
PLAN-V
1 other identifier
observational
150
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2021
CompletedFirst Submitted
Initial submission to the registry
September 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedMarch 7, 2024
March 1, 2024
3.2 years
September 28, 2021
March 5, 2024
Conditions
Outcome Measures
Primary Outcomes (8)
Antibody titres in biological samples
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
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
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
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.
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.
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.
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
Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns
During delivery admission
Secondary Outcomes (19)
Maternal death
through study completion, an average of 9 months
Maternal - Non-delivery hospitalization
through study completion, an average of 9 months)
Any infection
through study completion, an average of 9 months
Pre-term labour
through study completion, an average of 9 months
Hypertensive disorders of pregnancy
through study completion, an average of 9 months
- +14 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Canadian Institutes of Health Research (CIHR)collaborator
- Children's Hospital of Eastern Ontario Research Institutecollaborator
- University of Ottawacollaborator
Study Sites (7)
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 8E7, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
London Health Sciences
London, Ontario, N6A 5W9, Canada
The Ottawa Hospital - General
Ottawa, Ontario, K1H8L6, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Biospecimen
Should residual samples (i.e. maternal serum, umbilical cord serum, breast milk, placental tissue \[frozen and fixed\]) remain after the purposes of the primary outcomes, samples will be retained for up to 25 years for future, related REB approved studies.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darine El-Chaâr, MD, MSc
The Ottawa Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 28, 2021
First Posted
November 10, 2021
Study Start
June 3, 2021
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
March 7, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.