Clinical trial NCT05115617: Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study
Official title: Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SARS-CoV2 Infection
Covid19
Vaccine Reaction
Pregnancy Related
Immunogenicity
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Children's Hospital of Eastern Ontario Research Institute
name: University of Ottawa
First posted: 2021-11-10
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Antibody titres in biological samples
timeFrame: 1-month post COVID-19 vaccine
measure: Antibody titres in biological samples
timeFrame: 3-month, and 6-month post COVID-19 vaccine
measure: Antibody titres in biological samples
timeFrame: 6-month post COVID-19 vaccine
measure: Antibody titres in biological samples
timeFrame: At delivery
measure: Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
timeFrame: 6-months post-COVID-19 vaccine
measure: Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
timeFrame: 3-month post-COVID-19 vaccine
measure: Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
timeFrame: 1-month post-COVID-19 vaccine
measure: Antibody titres in biological samples of pregnant and non-pregnant populations
timeFrame: During delivery admission
Secondary outcomes:
measure: Maternal death
timeFrame: through study completion, an average of 9 months
measure: Maternal - Non-delivery hospitalization
timeFrame: through study completion, an average of 9 months)
measure: Any infection
timeFrame: through study completion, an average of 9 months
measure: Pre-term labour
timeFrame: through study completion, an average of 9 months
measure: Hypertensive disorders of pregnancy
timeFrame: through study completion, an average of 9 months
measure: Placental abruption
timeFrame: through study completion, an average of 9 months
measure: Postpartum hemorrhage
timeFrame: Post-delivery, during the delivery admission
measure: Preterm birth
timeFrame: through study completion, an average of 9 months
measure: Fetal loss or stillbirth
timeFrame: through study completion, an average of 9 months
measure: Small for gestational age
timeFrame: During the pregnancy, through study completion, an average of 9 months
measure: Term low birthweight
timeFrame: At delivery
measure: Low 5 min Apgar Score
timeFrame: At delivery
measure: Low cord blood pH
timeFrame: At delivery
measure: admission to neonatal ICU for >12 hours
timeFrame: During delivery admission
measure: composite neonatal adverse outcome indicator [NAOI]
timeFrame: At delivery
measure: Frequency of infection
timeFrame: Postpartum, through study completion, an average of 9 months
measure: Re-hospitalization rates
timeFrame: Postpartum, through study completion, an average of 9 months
measure: Composite indicator for complex chronic conditions
timeFrame: Postpartum, through study completion, an average of 9 months
measure: Infant death
timeFrame: Postpartum, through study completion, an average of 9 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Darine El-Chaâr, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: