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

Covid19 Clinical Trial

— PLAN-V  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115617
• Other study ID #: CTO 3612
• Status: Recruiting
• Start date: June 3, 2021
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Ottawa Hospital Research Institute
• Contact: Stephanie Boyd, MBA
• Phone: 613-737-8899
• Email: sboyd[@]ohri.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Immunogenicity
• Pregnancy Related
• SARS-CoV2 Infection
• Vaccine Reaction

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	London Health Sciences	London	Ontario
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	The Ottawa Hospital - General	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario Research Institute, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

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