Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study

Study Overview
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Brief Summary
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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
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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: To evaluate immunogenicity of COVID-19 vaccines in pregnant women/individuals and the fetal/newborn immune response to maternal vaccination. To evaluate safety of COVID-19 vaccination in pregnant women/individuals based on obstetrical, fetal and newborn health outcomes. To compare immune responses to COVID-19 vaccination and natural COVID-19 disease among pregnant women/individuals and their infants exposed in utero 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.

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

Conditions
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Covid19, SARS-CoV2 Infection, Vaccine Reaction, Pregnancy Related, Immunogenicity

Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant individuals<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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