Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ottawa Hospital Research Institute | OTHER |
| Vaccine Evaluation Center, Canada | OTHER |
| University of British Columbia | OTHER |
| Canadian Center for Vaccinology |
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Concurrent Assignment | Active Comparator |
| |
| Group 2: Sequential Assignment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tdap Vaccine Administration | Biological | The Tdap vaccine will be administered according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | From enrollment to the end of visit 4 (end of main study) at around 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 weeks after first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| (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 | Months 7 and 19 after delivery |
| (1) Exploratory: Measurement of RSV antibody responses in mothers 7 and 19 months after delivery |
Inclusion Criteria
Exclusion Criteria
Any of the following:
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.
Documented pertussis infection (by culture or polymerase chain reaction) within 2 years prior to vaccination.
Receipt of blood transfusion products within 6 months prior to vaccination.
Primary or secondary immunologic disorder or immunosuppression.
Any conditions that, in the investigator's judgement, may interfere with subject's ability to comply with study procedures or receipt of prenatal care, such as behavioural or cognitive impairment or neuropsychiatric illness.
Preconception diabetes mellitus (defined as: previous diagnosis of diabetes while not pregnant OR First trimester hemoglobin A1c level of 6.5% [47.5 mmol/mol] OR First trimester fasting blood glucose 126 mg/dL [7 mmol/L]).
Preconception chronic hypertension (defined as: sustained elevation in the systolic blood pressure to ≥140 mmHg or the diastolic blood pressure to ≥90 mmHg, that is diagnosed either prior to pregnancy or prior to 20 WG).
Congenital anomalies per ultrasound.
Hepatitis B infection; Hepatitis C infection; Untreated syphilis.
Contraindication to receipt of Tdap (BOOSTRIX, GSK): a) Hypersensitivity to any component of the Tdap (BOOSTRIX, GSK) vaccine or individuals having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines; b) Encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis containing vaccine; c) Transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus.
Contraindication to receipt of RSVpreF (ABRYSVOTM, Pfizer): Hypersensitivity to the active substance or to any component of the vaccine.
Pregnancy complications at the time of recruitment that are risk factors for preterm delivery:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bahaa Abu-Raya, M.D, PhD | Contact | (902) 470-8142 | bh723616@dal.ca | |
| CTN CIRN Central Inbox | Contact | CTN.CIRN@iwk.nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Bahaa Abu-Raya, M.D., PhD | Canadian Center for Vaccinology, Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Evaluation Center | Active, not recruiting | Vancouver | British Columbia | Canada | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Dalhousie University | OTHER |
| IWK Health Centre | OTHER |
| Public Health Agency of Canada (PHAC) | OTHER_GOV |
| Centre Hospitalier Univeritaire Sainte Justine | UNKNOWN |
Not provided
Not provided
Not provided
Data Safety Monitoring Board members, unless unblinding is required to provide a comprehensive safety assessment.
|
| RSV Vaccine | Biological | 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 | 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. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 14 weeks after vaccination with RSV vaccine |
Prefusion RSV F protein IgG in mothers 7 and 19 months after delivery |
| 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. | 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. | 1 week, 2 weeks, 4 weeks and 2 months after delivery |
| Canadian Center for Vaccinology |
| Recruiting |
| Halifax |
| Nova Scotia |
| Canada |
|
| The Ottawa Hospital Research Institute | Recruiting | Ottawa | Ontario | Canada |
|
| Centre hospitalier universitaire Ste-Justine | Recruiting | Montreal | Quebec | Canada |
|
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C505143 | Boostrix |
| D022261 | Respiratory Syncytial Virus Vaccines |
| C000729228 | abrysvo |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided