Recruiting

COVID-19 Vaccination

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05115617

Conditions

SARS-CoV2 Infection

Covid19

Vaccine Reaction

Pregnancy Related

Immunogenicity

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

SARS-CoV2 Infection

Covid19

Vaccine Reaction

Pregnancy Related

Immunogenicity

Study ID

NCT05115617

Start date

Jun 3, 2021

Status verified date

Mar, 2024

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Antibody titres in biological samples [ Time Frame: 1-month post COVID-19 vaccine ]
  • Antibody titres in biological samples [ Time Frame: 3-month, and 6-month post COVID-19 vaccine ]
  • Antibody titres in biological samples [ Time Frame: 6-month post COVID-19 vaccine ]
  • Antibody titres in biological samples [ Time Frame: At delivery ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Antibody titres in biological samples of pregnant and non-pregnant populations [ Time Frame: During delivery admission ]

Central Contacts and Locations

Central contacts

Stephanie Boyd, MBA

613-737-8899sboyd@ohri.ca

Alysha Harvey, MSc

613-737-8899alyharvey@ohri.ca

Locations

The Ottawa Hospital - General

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Stephanie Boyd, MBA

613-737-8899sboyd@ohri.ca

Alysha Harvey, MSc

613-737-8899alyharvey@ohri.ca

Principal Investigator:

Darine El-Chaâr, MD, MSc

The Ottawa Hospital - Civic Campus

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Stephanie Boyd, MBA

613-737-8899sboyd@ohri.ca

Alysha Harvey, MSc

613-737-8899alyharvey@ohri.ca

Principal Investigator:

Jessica Dy, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 7, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-03-07.