SARS-CoV2 InfectionPLAN-VNCT05115617
Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study
An observational study of SARS-CoV2 Infection and Covid19, run by Ottawa Hospital Research Institute at 7 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, Covid19, Vaccine Reaction
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 7 sitesCanada
- Study dates
- 3 Jun 2021to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Not yet recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 8E7
Sarah McDonald, MD, mcdonals@mcmaster.ca
L. MacDonald, lmacdon@mcmaster.ca
- Not yet recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Laura Gaudet, MD, laura.gaudet@kingstonhsc.ca
Jessica Pudwell, MSc, MPH, jessica.pudwell@queensu.ca
- Not yet recruiting
London Health Sciences
London, Ontario, N6A 5W9
Barbra deVrijer, MD, barbra.devrijer@lhsc.on.ca
Jennifer Ryder, jennifer.ryder@lhsc.on.ca
- Recruiting
The Ottawa Hospital - General
Ottawa, Ontario, K1H8L6
Stephanie Boyd, MBA, 613-737-8899 ext. 77295, sboyd@ohri.ca
Alysha Harvey, MSc, 613-737-8899 ext. 73838, alyharvey@ohri.ca
- Recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Stephanie Boyd, MBA, 613-737-8899 ext. 77295, sboyd@ohri.ca
Alysha Harvey, MSc, 613-737-8899 ext. 73838, alyharvey@ohri.ca
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Amir Aviram, MD, amir.aviram@sunnybrook.ca
Susan O'Rinn, susan.orinn@sunnybrook.ca
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Howard Berger, MD, howard.berger@unityhealth.to
Arifa Rahman, M.B.B.S, MPH, arifa.rahman@unityhealth.to
About this study
Official title: Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study
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.
Read the 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:
- 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.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During delivery admission
Secondary outcomes (19)
Maternal death
Maternal death during delivery admission
Measured: through study completion, an average of 9 months
Maternal - Non-delivery hospitalization
Any hospitalization not associated with the delivery of infant.
Measured: through study completion, an average of 9 months)
Any infection
Maternal diagnosis of any infection during pregnancy
Measured: through study completion, an average of 9 months
Pre-term labour
The onset of labour prior to 37 weeks gestation
Measured: through study completion, an average of 9 months
Hypertensive disorders of pregnancy
The diagnosis of a hypertensive disorder of pregnancy
Measured: through study completion, an average of 9 months
Placental abruption
The diagnosis of placental abruption during pregnancy
Measured: through study completion, an average of 9 months
Postpartum hemorrhage
The diagnosis of postpartum hemorrhage
Measured: Post-delivery, during the delivery admission
Preterm birth
Infant born prior to 37 weeks gestation
Measured: through study completion, an average of 9 months
Fetal loss or stillbirth
Fetal loss or stillbirth throughout the pregnancy
Measured: through study completion, an average of 9 months
Small for gestational age
<10th percentile for gestational age and sex- specific birth weight
Measured: During the pregnancy, through study completion, an average of 9 months
Term low birthweight
<2500g
Measured: At delivery
Low 5 min Apgar Score
Score <5 at 5 minutes
Measured: At delivery
Low cord blood pH
cord blood pH<7.0
Measured: At delivery
admission to neonatal ICU for >12 hours
Infant admission to the neonatal ICU for >12 hours
Measured: During delivery admission
composite neonatal adverse outcome indicator [NAOI]
A composite indicator which includes various neonatal adverse outcomes
Measured: At delivery
Frequency of infection
Number of infections, including but not limited to: influenza, pneumonia, sepsis, acute respiratory infections, gastrointestinal
Measured: Postpartum, through study completion, an average of 9 months
Re-hospitalization rates
Number of re-hospitalizations and emergency visits
Measured: 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
Measured: Postpartum, through study completion, an average of 9 months
Infant death
Infant death
Measured: Postpartum, through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start3 Jun 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario Research Institute, University of Ottawa
- Responsible party
- Principal investigator, Darine El-Chaâr, Ottawa Hospital Research Institute
- Investigators
- Darine El-Chaâr, MD, MSc, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115617
- Sponsor's protocol ID
- CTO 3612
- Acronym
- PLAN-V
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05115617
- Acronym / sponsor ID
- PLAN-V / CTO 3612
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario Research Institute, University of Ottawa
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antibody titres in biological samples
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: During delivery admission
Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns
19 secondary outcomes
Maternal death
Time frame: through study completion, an average of 9 months
Maternal - Non-delivery hospitalization
Time frame: through study completion, an average of 9 months)
Any infection
Time frame: through study completion, an average of 9 months
Pre-term labour
Time frame: through study completion, an average of 9 months
Hypertensive disorders of pregnancy
Time frame: through study completion, an average of 9 months
Placental abruption
Time frame: through study completion, an average of 9 months
Postpartum hemorrhage
Time frame: Post-delivery, during the delivery admission
Preterm birth
Time frame: through study completion, an average of 9 months
Fetal loss or stillbirth
Time frame: through study completion, an average of 9 months
Small for gestational age
Time frame: During the pregnancy, through study completion, an average of 9 months
Term low birthweight
Time frame: At delivery
Low 5 min Apgar Score
Time frame: At delivery
Low cord blood pH
Time frame: At delivery
admission to neonatal ICU for >12 hours
Time frame: During delivery admission
composite neonatal adverse outcome indicator [NAOI]
Time frame: At delivery
Frequency of infection
Time frame: Postpartum, through study completion, an average of 9 months
Re-hospitalization rates
Time frame: Postpartum, through study completion, an average of 9 months
Composite indicator for complex chronic conditions
Time frame: Postpartum, through study completion, an average of 9 months
Infant death
Time frame: Postpartum, through study completion, an average of 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No. IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darine El-Chaâr, MD, MSc principal investigator
The Ottawa Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection and Covid19, run by Ottawa Hospital Research Institute at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Boyd, MBA (613-737-8899 ext. 77295, sboyd@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titres in biological samples (time frame: 1-month post COVID-19 vaccine). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.