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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Children's Hospital of Eastern Ontario Research Institute | OTHER |
| University of Ottawa | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Boyd, MBA | Contact | 613-737-8899 | 77295 | sboyd@ohri.ca |
| Alysha Harvey, MSc | Contact | 613-737-8899 | 73838 | alyharvey@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Darine El-Chaâr, MD, MSc | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences Corporation | Not yet recruiting | Hamilton | Ontario | L8L 8E7 | Canada |
IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2021 | Oct 29, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
| 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 |
| 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 |
| Kingston Health Sciences Centre | Not yet recruiting | Kingston | Ontario | K7L 2V7 | Canada |
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| London Health Sciences | Not yet recruiting | London | Ontario | N6A 5W9 | Canada |
|
| The Ottawa Hospital - General | Recruiting | Ottawa | Ontario | K1H8L6 | Canada |
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| The Ottawa Hospital - Civic Campus | Recruiting | Ottawa | Ontario | K1Y 4E9 | Canada |
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| Sunnybrook Health Sciences Centre | Not yet recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| St. Michael's Hospital | Not yet recruiting | Toronto | Ontario | M5B 1W8 | Canada |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |