Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy

ConditionsRSV Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination Pregnancy Healthy

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18-49

SponsorCanadian Immunization Research Network

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Healthy pregnant individuals with a singleton pregnancy aged 18-49 years.

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.

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

Disqualifiers

Informed consent read, understood and signed prior to study-specific procedures.

Receipt of RSV vaccine anytime.

Receipt of immunoglobulins (except Rho D) within 1 year prior to vaccination.

Documented receipt of pertussis vaccine within 2 years prior to vaccination.

Trial design

Design model

Crossover

Treatments tested in this trial

Tdap Vaccine Administration
Biological/Vaccine
The Tdap vaccine will be administered according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.
RSV Vaccine
Biological/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.
Saline (as a placebo)
Other intervention
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Group 1: Concurrent AssignmentActive comparator 3 interventions

Group B: Group 2: Sequential AssignmentActive comparator 3 interventions

Trial outcomes

Primary outcomes

Feasibility 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

Secondary outcomes

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

Other outcomes

(1) Exploratory: Measurement of anti-B. pertussis responses in mothers 7 and 19 months after delivery

Anti-B. pertussis IgG in mothers 7 and 19 months after delivery

Time frame

Months 7 and 19 after delivery

(1) Exploratory: Measurement of RSV antibody responses in mothers 7 and 19 months after delivery

Prefusion RSV F protein IgG in mothers 7 and 19 months after delivery

Time frame

Months 7 and 19 after delivery

(2) Exploratory: Measurement of anti-B. pertussis antibody levels in infants at 2, 7 and 19 months of age born to mothers who received concurrent and sequential administration of vaccines against pertussis and RSV in pregnancy

Anti-B. pertussis IgG in infants at 2, 7 and 19 months of age.

Time frame

Infants at 2, 7 and 19 months of age

(3) Exploratory: Measurement of anti-RSV antibody levels in breast milk in mothers at 1 week, 2 weeks, 4 weeks and 2 months after delivery following concurrent and sequential administration of vaccines against pertussis and RSV in pregnancy

Anti-RSV antibody levels in breast milk of others at 1 week, 2 weeks, 4 weeks and 2 months after delivery.

Time frame

1 week, 2 weeks, 4 weeks and 2 months after delivery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Immunization Research Network

Lead sponsor

Ottawa Hospital Research Institute

Collaborator

Vaccine Evaluation Center, Canada

Collaborator

University of British Columbia

Collaborator

Canadian Center for Vaccinology

Collaborator

Dalhousie University

Collaborator

IWK Health Centre

Collaborator

Public Health Agency of Canada (PHAC)

Collaborator

Centre Hospitalier Univeritaire Sainte Justine

Collaborator

Source ClinicalTrials.gov

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