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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
The Tdap vaccine will be administered according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.
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.
Vaccine Evaluation Center
Vancouver, British Columbia, Canada
RECRUITINGCanadian Center for Vaccinology
Halifax, Nova Scotia, Canada
RECRUITINGThe Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
RECRUITINGCentre hospitalier universitaire Ste-Justine
Montreal, Quebec, Canada
NOT_YET_RECRUITINGFeasibility of conducting a randomized controlled trial - Screening Rate
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.
Time frame: From enrollment to the end of visit 4 (end of main study) at around 12 weeks
Feasibility of conducting a randomized controlled trial - Consent & Randomization Rate
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.
Time frame: From enrollment to the end of visit 4 (end of main study) at around 12 weeks
Feasibility of conducting a randomized controlled trial - Retention Rate
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.
Time frame: From enrollment to the end of visit 4 (end of main study) at around 12 weeks
Feasibility of conducting a randomized controlled trial - Trial Protocol Compliance Rate
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.
Time frame: From enrollment to the end of visit 4 (end of main study) at around 12 weeks
Safety Outcomes - Rates of Adverse Events Following Immunization in Participants
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.
Time frame: Up to 14 weeks after first vaccination
Safety Outcomes - Rates of Adverse Events of Special Interest in Participants during Pregnancy and Delivery
Rates of Adverse Events of Special Interest in Participants during pregnancy and delivery.
Time frame: Up to 14 weeks after first vaccination
Safety Outcomes - Rates of Serious Adverse Events in Participants during Pregnancy and Delivery
Rates of Serious Adverse Events in Participants during pregnancy and delivery.
Time frame: Up to 14 weeks after first vaccination
Immunogenicity - Seroconversion rate of anti-pertussis toxin IgG
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.
Time frame: 4 weeks after vaccination with Tdap
Immunogenicity - Seroconversion rate of anti-Filamentous hemagglutinin IgG
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.
Time frame: 4 weeks after vaccination with Tdap
Immunogenicity - Seroconversion rate of anti-Pertactin IgG
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.
Time frame: 4 weeks after vaccination with Tdap
Immunogenicity - Seroconversion rate of Prefusion RSV F protein IgG
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.
Time frame: 4 weeks after vaccination with RSV vaccine
Immunogenicity - Anti-Pertussis toxin IgG levels at term birth (maternal and cord sera)
Geometric mean concentrations of antibody levels and 95% CI will be calculated.
Time frame: Up to 14 weeks after vaccination with Tdap
Immunogenicity - Anti-Filamentous hemagglutinin IgG levels at term birth (maternal and cord sera)
Geometric mean concentrations of antibody levels and 95% CI will be calculated.
Time frame: Up to 14 weeks after vaccination with Tdap
Immunogenicity - Anti-Pertactin IgG levels at term birth (maternal and cord sera)
Geometric mean concentrations of antibody levels and 95% CI will be calculated.
Time frame: Up to 14 weeks after vaccination with Tdap
Immunogenicity - Prefusion RSV F protein IgG levels at term birth (maternal and cord sera)
Geometric mean concentrations of antibody levels and 95% CI will be calculated.
Time frame: Up to 14 weeks after vaccination with RSV vaccine
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.