Covid19, Immunogenicity, Pregnancy Related, SARS-CoV2 Infection, Vaccine Reaction
Conditions
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.
Interventions
None listed
Sponsors
Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario Research Institute
University of Ottawa
Ottawa Hospital Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 pregnant and non-pregnant populations | During delivery admission | Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypertensive disorders of pregnancy | through study completion, an average of 9 months | The diagnosis of a hypertensive disorder of pregnancy |
| Maternal death | through study completion, an average of 9 months | Maternal death during delivery admission |
| 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 |
| Maternal - Non-delivery hospitalization | through study completion, an average of 9 months) | Any hospitalization not associated with the delivery of infant. |
| 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 | Infant death |
| Low 5 min Apgar Score | At delivery | Score \<5 at 5 minutes |
| 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 |
Countries
Canada
Contacts
Primary ContactStephanie Boyd, MBA
Backup ContactAlysha Harvey, MSc
Outcome results
None listed