PLAN-V: Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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:
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To evaluate immunogenicity of COVID-19 vaccines in pregnant women/individuals and the fetal/newborn immune response to maternal vaccination.
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To evaluate safety of COVID-19 vaccination in pregnant women/individuals based on obstetrical, fetal and newborn health outcomes.
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To compare immune responses to COVID-19 vaccination and natural COVID-19 disease among pregnant women/individuals and their infants exposed in utero
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Antibody titres in biological samples [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.
- Antibody titres in biological samples [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.
- Antibody titres in biological samples [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.
- Antibody titres in biological samples [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.
- Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease. [6-months post-COVID-19 vaccine]
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
- Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease. [3-month post-COVID-19 vaccine]
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
- Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease. [1-month post-COVID-19 vaccine]
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
- Antibody titres in biological samples of pregnant and non-pregnant populations [During delivery admission]
Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns
Secondary Outcome Measures
- Maternal death [through study completion, an average of 9 months]
Maternal death during delivery admission
- Maternal - Non-delivery hospitalization [through study completion, an average of 9 months)]
Any hospitalization not associated with the delivery of infant.
- Any infection [through study completion, an average of 9 months]
Maternal diagnosis of any infection during pregnancy
- Pre-term labour [through study completion, an average of 9 months]
The onset of labour prior to 37 weeks gestation
- Hypertensive disorders of pregnancy [through study completion, an average of 9 months]
The diagnosis of a hypertensive disorder of pregnancy
- Placental abruption [through study completion, an average of 9 months]
The diagnosis of placental abruption during pregnancy
- Postpartum hemorrhage [Post-delivery, during the delivery admission]
The diagnosis of postpartum hemorrhage
- Preterm birth [through study completion, an average of 9 months]
Infant born prior to 37 weeks gestation
- Fetal loss or stillbirth [through study completion, an average of 9 months]
Fetal loss or stillbirth throughout the pregnancy
- Small for gestational age [During the pregnancy, through study completion, an average of 9 months]
<10th percentile for gestational age and sex- specific birth weight
- Term low birthweight [At delivery]
<2500g
- Low 5 min Apgar Score [At delivery]
Score <5 at 5 minutes
- Low cord blood pH [At delivery]
cord blood pH<7.0
- admission to neonatal ICU for >12 hours [During delivery admission]
Infant admission to the neonatal ICU for >12 hours
- composite neonatal adverse outcome indicator [NAOI] [At delivery]
A composite indicator which includes various neonatal adverse outcomes
- Frequency of infection [Postpartum, through study completion, an average of 9 months]
Number of infections, including but not limited to: influenza, pneumonia, sepsis, acute respiratory infections, gastrointestinal
- Re-hospitalization rates [Postpartum, through study completion, an average of 9 months]
Number of re-hospitalizations and emergency visits
- Composite indicator for complex chronic conditions [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
- Infant death [Postpartum, through study completion, an average of 9 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women/Individuals ≥ 16 years of age who are ≥7 0/7 weeks' gestation on the day of enrollment
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Capacity to provide informed consent and to comprehend and comply with the study requirements
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Planning to deliver at a participating site hospital
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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:
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Cases with known major fetal concerns
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Women/Individuals who are fully vaccinated against COVID-19
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Women/Individuals who are pregnant due to surrogacy, or planning to give their child up for adoption
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Women/Individuals with a non-viable pregnancy (e.g., ectopic)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamilton Health Sciences Corporation | Hamilton | Ontario | Canada | L8L 8E7 |
| 2 | Kingston Health Sciences Centre | Kingston | Ontario | Canada | K7L 2V7 |
| 3 | London Health Sciences | London | Ontario | Canada | N6A 5W9 |
| 4 | The Ottawa Hospital - General | Ottawa | Ontario | Canada | K1H8L6 |
| 5 | The Ottawa Hospital - Civic Campus | Ottawa | Ontario | Canada | K1Y 4E9 |
| 6 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 7 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
Sponsors and Collaborators
- Ottawa Hospital Research Institute
- Canadian Institutes of Health Research (CIHR)
- Children's Hospital of Eastern Ontario Research Institute
- University of Ottawa
Investigators
- Principal Investigator: Darine El-Chaâr, MD, MSc, The Ottawa Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- CTO 3612