Tdap + RSV Vaccines for Pregnancy

(CosTaR Trial)

Recruiting at 3 trial locations

Overseen By CTN CIRN Central Inbox

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Canadian Immunization Research Network

Must not be taking: Immunoglobulins, Blood transfusions

Disqualifiers: Immunosuppression, Diabetes, Hypertension, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether the RSV and Tdap vaccines are more effective and safer when administered together during a single visit or separately at different visits to pregnant individuals. RSV can cause lung infections, while Tdap protects against whooping cough. Participants will be randomly assigned to one of two groups: one group will receive both vaccines at the same visit, and the other will receive them at different visits. Those who are healthy, pregnant with one baby, and between 28 and nearly 30 weeks along may be suitable for this trial. As a Phase 4 trial, the vaccines have already received FDA approval and proven effective, and this research seeks to understand how they benefit more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to ensure they don't interfere with the study.

What is the safety track record for the Tdap and RSV vaccines?

A previous study showed that the RSV vaccine given to pregnant individuals did not lead to more early births or pregnancy problems. Another study found no increase in deaths among mothers after receiving the RSV vaccine, indicating it is quite safe for pregnancy.

Regarding the Tdap vaccine, research has shown it is very safe for pregnant women and their babies. It does not increase the risk of issues like early birth, miscarriage, or stillbirth. In fact, receiving the Tdap vaccine during pregnancy helps protect babies from whooping cough.

Both vaccines have strong safety records, making them good options for expectant mothers. This trial will determine whether taking them together or separately during pregnancy is best, but the vaccines themselves are well-tested and well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because combining the Tdap and RSV vaccines during pregnancy could offer dual protection against whooping cough and respiratory syncytial virus (RSV), two significant threats to newborns. Unlike traditional approaches where these vaccines are given separately, this method explores concurrent administration, potentially simplifying vaccine schedules for expectant mothers. Additionally, delivering these vaccines during pregnancy may provide newborns with early immunity, offering immediate protection from birth. This innovative approach could lead to better health outcomes for both mothers and their babies by ensuring timely and efficient vaccination.

What evidence suggests that this trial's treatments could be effective for pregnancy?

Research has shown that the RSV vaccine, which participants in this trial may receive, is effective during pregnancy. It reduces the chance of babies being hospitalized for RSV by 57% and offers 65.5% protection against respiratory infections in the first six months of life. The Tdap vaccine, another treatment option in this trial, is also highly effective for pregnant individuals, with a 72% success rate in preventing whooping cough (pertussis) in infants under 3 months. Studies have found both vaccines to be safe for pregnant individuals, with no significant negative effects on birth outcomes. This trial will compare the concurrent administration of these vaccines with their sequential administration to evaluate their combined protective effects for both the mother and baby against serious illnesses. ^{2 3 6 7 8}

Who Is on the Research Team?

Bahaa Abu-Raya, M.D., PhD

Principal Investigator

Canadian Center for Vaccinology, Dalhousie University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who are healthy and have not yet received Tdap (protects against tetanus, diphtheria, pertussis) or RSV (respiratory syncytial virus) vaccines. Participants must be willing to follow the study schedule with multiple visits and keep a symptom diary.

Inclusion Criteria

My pregnancy is between 28 and almost 30 weeks.

Able to comply with the study procedures required to achieve primary objective of this pilot trial

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

Exclusion Criteria

I haven't received immunoglobulins (except Rho D) in the last year.

Conditions that may interfere with subject's ability to comply with study procedures or receipt of prenatal care

Congenital anomalies per ultrasound

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tdap and RSV vaccines either concurrently or sequentially, with blood collection and monitoring

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and immunogenicity assessments

14 weeks

Exploratory

Optional participation to measure antibody levels in mothers and infants at various time points post-delivery

19 months

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RSV Vaccine
• Tdap Vaccine

Trial Overview The trial tests whether it's more effective and safe to give Tdap and RSV vaccines together during one visit or separately across different visits in pregnancy. It involves random assignment to either concurrent or sequential vaccination groups.

How Is the Trial Designed?

Group I: Group 1: Concurrent Assignment Active Control 3 Interventions

Group II: Group 2: Sequential Assignment Active Control 3 Interventions

Who Is Running the Clinical Trial?

Canadian Immunization Research Network

Lead Sponsor

Trials

12

Recruited

10,600+

Centre Hospitalier Univeritaire Sainte Justine

Collaborator

Trials

1

Recruited

8,800+

Vaccine Evaluation Center, Canada

Collaborator

Trials

3

Recruited

340+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Canadian Center for Vaccinology

Collaborator

Trials

12

Recruited

6,300+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Centre Hospitalier Universitaire Sainte-Justine (CHU-SJ) (University of Montreal)

Collaborator

Trials

1

Recruited

20+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820867

Perinatal Outcomes After RSV Vaccination During Pregnancy This study showed no increase in the rate of preterm birth among vaccinated pregnant individuals; 5.9% of RSVpreF-vaccinated pregnancies and 6.7% of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38695784/

Respiratory syncytial virus vaccination during pregnancy ... Maternal RSV vaccination may have little or no effect on the risk of stillbirth (RR 0.81, 95% CI 0.38 to 1.72; 3 per 1000 with placebo, no ...

3. cdc.gov cdc.gov/rsv/hcp/vaccine-clinical-guidance/pregnant-people.html

RSV Vaccine Guidance for Pregnant Women In the same trial, the RSV vaccine reduced the risk of the baby being hospitalized for RSV by 57% and risk of having a healthcare visit for RSV ...

4. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf033/7989397

Efficacy, Immunogenicity, and Safety of an Investigational ... During the first 6 months of life, vaccine efficacy was 65.5% against medically assessed RSV-LRTD of any severity, 69.0% against severe ...

5. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00231-2/fulltext?rss=yes

Maternal vaccination to prevent severe RSV disease in ... Effectiveness against severe RSV-associated LRTD hospitalisation was 77% (45–90) from birth to age 6 months. Vaccine effectiveness was similar ...

6. cdc.gov cdc.gov/rsvvaxview/dashboard/pregnant-women-coverage.html

Respiratory Syncytial Virus (RSV) Vaccination Coverage ... Weekly RSV vaccination coverage estimates for pregnant women are based on electronic health record data from the Vaccine Safety Datalink.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X25007947

Safety monitoring of Pfizer's Respiratory Syncytial Virus ... The most commonly reported pregnancy-specific outcomes were preterm birth in 37 (31 %) and hypertensive disorders of pregnancy in 9 (7 %).

8. news.cornell.edu news.cornell.edu/stories/2024/07/study-backs-rsv-vaccine-safety-during-pregnancy

Study backs RSV vaccine safety during pregnancy Vaccinating mothers against RSV during late pregnancy to protect their newborns is not associated with an increased risk of preterm birth or ...