RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Pregnancy, Healthy
Conditions
Keywords
RSV, Tdap, Pregnancy, Clinical trial, Vaccine
Brief summary
The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the same visit, or separately at different visits. This clinical trial will also learn about the safety and immune responses of these vaccines in pregnancy. The Main question: -Is it possible to run a successful trial that tests how safe and effective it is to give Tdap and RSV vaccines in pregnancy either at the same time or one after the other, at different visits? The Secondary question: -To determine how safe and how well the Tdap and RSV vaccines work when given in pregnancy either at the same time or one after the other, at different visits. The Exploratory (optional participation) questions: * To measure the levels of antibodies against whooping cough (pertussis) and RSV in mothers at 7 and 19 months after giving birth, depending on whether they got the vaccines at the same time or one after the other during pregnancy. * To measure whooping cough antibody levels in the babies at 2, 7, and 19 months of age, whose mothers who received the vaccines in pregnancy. * To measure the levels of RSV antibodies in the mothers' breast milk at 1 week, 2 weeks, 4 weeks, and 2 months after giving birth. Participants will be randomly assigned to Group 1 (vaccines given at the same time, same visit) or Group 2 (vaccines given one after the other, at different visits). There are 4 visits as part of the main study, and 6 additional visits as part of the optional study (exploratory questions). Visit 1-2: Blood collection and vaccines administered Visit 3-4: Blood work (cord blood sample collection from infant, after delivery, if possible) Visit 5-8: Breast milk collection Visit 8-10: Blood collection (infant blood collection only at Visit 8). Participants will be asked to keep a diary of symptoms throughout the study.
Interventions
BIOLOGICALTdap Vaccine Administration
The Tdap vaccine will be administered according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.
BIOLOGICALRSV Vaccine
The RSVpreF vaccine will be administered according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.
Normal saline (0.5mL) will be administered as a placebo according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.
Sponsors
Canadian Immunization Research Network
Ottawa Hospital Research Institute
Vaccine Evaluation Center, Canada
University of British Columbia
Canadian Center for Vaccinology
Dalhousie University
IWK Health Centre
Public Health Agency of Canada (PHAC)
Centre Hospitalier Univeritaire Sainte Justine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Data Safety Monitoring Board members, unless unblinding is required to provide a comprehensive safety assessment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy pregnant individuals with a singleton pregnancy aged 18-49 years. 2. Gestational age 28-29+6 WG at time of study screening, enrolment and randomization as per documented first trimester (less than or equal to13+6 WG) ultrasound, or the first date of last menstrual period if ultrasound not obtained in the first trimester, or the age of the embryo and the date of transfer if pregnancy resulted from assisted reproductive technology. 3. Able to comply with the study procedures required to achieve primary objective of this pilot trial (not being able to comply with procedures required to achieve exploratory objectives is not an
Exclusion criteria
). 4. Informed consent read, understood and signed prior to study-specific procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of conducting a randomized controlled trial - Retention Rate | From enrollment to the end of visit 4 (end of main study) at around 12 weeks | To evaluate the feasibility of conducting a randomized controlled trial (RCT) that would test the safety and immunogenicity of Tdap and RSV concurrent and sequential administration in pregnancy. Proportion of randomized participants who complete the first four study visits in each site and overall. |
| Feasibility of conducting a randomized controlled trial - Trial Protocol Compliance Rate | From enrollment to the end of visit 4 (end of main study) at around 12 weeks | To evaluate the feasibility of conducting a randomized controlled trial (RCT) that would test the safety and immunogenicity of Tdap and RSV concurrent and sequential administration in pregnancy. Percentage of participants who do not deviate from the protocol and complete vaccination and the first four visits in each site and overall. |
| Feasibility of conducting a randomized controlled trial - Screening Rate | From enrollment to the end of visit 4 (end of main study) at around 12 weeks | To evaluate the feasibility of conducting a randomized controlled trial (RCT) that would test the safety and immunogenicity of Tdap and RSV concurrent and sequential administration in pregnancy. Number of participants screened monthly in each site and overall. |
| Feasibility of conducting a randomized controlled trial - Consent & Randomization Rate | From enrollment to the end of visit 4 (end of main study) at around 12 weeks | To evaluate the feasibility of conducting a randomized controlled trial (RCT) that would test the safety and immunogenicity of Tdap and RSV concurrent and sequential administration in pregnancy. Proportion/number of participants who consent and successfully randomized out of screened individuals in each site and overall. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity - Seroconversion rate of anti-pertussis toxin IgG | 4 weeks after vaccination with Tdap | Seroconversion rate of anti-pertussis toxin IgG 4 weeks after vaccination with Tdap vaccine in the concurrent versus sequential groups. For the secondary immunogenicity outcome, fold change in antibody levels between pre-vaccination and 4-weeks after vaccination will be calculated. Seroconversion rates and their 95% CI will be calculated and described. Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Immunogenicity - Seroconversion rate of anti-Filamentous hemagglutinin IgG | 4 weeks after vaccination with Tdap | Seroconversion rate of anti-Filamentous hemagglutinin IgG 4 weeks after vaccination with Tdap vaccine in the concurrent versus sequential groups. For the secondary immunogenicity outcome, fold change in antibody levels between pre-vaccination and 4-weeks after vaccination will be calculated. Seroconversion rates and their 95% CI will be calculated and described. Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Immunogenicity - Seroconversion rate of anti-Pertactin IgG | 4 weeks after vaccination with Tdap | Seroconversion rate of anti-Pertactin IgG 4 weeks after vaccination with Tdap vaccine in the concurrent versus sequential groups. For the secondary immunogenicity outcome, fold change in antibody levels between pre-vaccination and 4-weeks after vaccination will be calculated. Seroconversion rates and their 95% CI will be calculated and described. Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Immunogenicity - Seroconversion rate of Prefusion RSV F protein IgG | 4 weeks after vaccination with RSV vaccine | Seroconversion rate of Prefusion RSV F protein IgG 4 weeks after vaccination with RSV vaccine in the concurrent versus sequential groups. For the secondary immunogenicity outcome, fold change in antibody levels between pre-vaccination and 4-weeks after vaccination will be calculated. Seroconversion rates and their 95% CI will be calculated and described. Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Immunogenicity - Anti-Pertussis toxin IgG levels at term birth (maternal and cord sera) | Up to 14 weeks after vaccination with Tdap | Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Immunogenicity - Anti-Filamentous hemagglutinin IgG levels at term birth (maternal and cord sera) | Up to 14 weeks after vaccination with Tdap | Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Immunogenicity - Anti-Pertactin IgG levels at term birth (maternal and cord sera) | Up to 14 weeks after vaccination with Tdap | Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Immunogenicity - Prefusion RSV F protein IgG levels at term birth (maternal and cord sera) | Up to 14 weeks after vaccination with RSV vaccine | Geometric mean concentrations of antibody levels and 95% CI will be calculated. |
| Safety Outcomes - Rates of Adverse Events Following Immunization in Participants | Up to 14 weeks after first vaccination | In this study, an adverse event will be categorized as an AEFI if it meets the relevant provincial reporting criteria and occurs after vaccination and up until delivery. Rates of Adverse Events Following Immunization in Participants. |
| Safety Outcomes - Rates of Adverse Events of Special Interest in Participants during Pregnancy and Delivery | Up to 14 weeks after first vaccination | Rates of Adverse Events of Special Interest in Participants during pregnancy and delivery. |
| Safety Outcomes - Rates of Serious Adverse Events in Participants during Pregnancy and Delivery | Up to 14 weeks after first vaccination | Rates of Serious Adverse Events in Participants during pregnancy and delivery. |
Countries
Canada
Contacts
CONTACTBahaa Abu-Raya, M.D, PhD
CONTACTCTN CIRN Central Inbox
PRINCIPAL_INVESTIGATORBahaa Abu-Raya, M.D., PhD
Canadian Center for Vaccinology, Dalhousie University
Outcome results
None listed