RSV Vaccine for Respiratory Syncytial Virus

No longer recruiting at 11 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Corticosteroids, Aspirin, others

Disqualifiers: Immunodeficiency, Chronic illness, COVID-19, others

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine for RSV, a virus that can cause serious lung infections in babies and toddlers. The researchers aim to determine how the vaccine spreads in the body and whether it remains consistent after two doses given 56 days apart. Suitable participants are healthy infants and toddlers who regularly attend daycare and have other children of similar age in their household or daycare. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the vaccine works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking medical research.

Do I have to stop taking my current medications for the RSV vaccine trial?

The trial does not specify if you need to stop taking your current medications, but certain medications like immunosuppressive therapy, corticosteroids, and specific vaccines are not allowed close to the time of enrollment. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

Is there any evidence suggesting that the RSVt Vaccine is likely to be safe for humans?

Research shows that the RSVt vaccine, administered as a nasal spray to protect against Respiratory Syncytial Virus, has undergone safety testing in babies and young children. In earlier studies, many participants experienced mild to moderate reactions, such as fever and a runny nose, after receiving the vaccine. These reactions are common with vaccines and usually resolve on their own.

However, any vaccine can sometimes cause more serious allergic reactions, which are rare but require immediate medical attention if they occur. This trial, in its early stages, aims to understand how well young children tolerate the vaccine. As the vaccine remains under study, additional information will enhance understanding of its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the RSVt Vaccine because it introduces a new way to potentially prevent Respiratory Syncytial Virus (RSV) infections. Unlike current treatments that mainly involve supportive care and, in some cases, antiviral medications, this vaccine is designed to proactively prevent the virus. The RSVt Vaccine is unique in its delivery method, being administered intranasally, which could enhance its effectiveness by targeting the virus directly at its entry point in the respiratory system. This approach not only aims to protect individuals from severe RSV infections but also represents a shift toward preventive care rather than just managing symptoms.

What evidence suggests that the RSVt Vaccine might be an effective treatment for Respiratory Syncytial Virus?

Research has shown that vaccines for respiratory syncytial virus (RSV) help reduce infections in infants. A Cochrane review found that RSV vaccines lower the risk of infection in both older adults and infants. Another study demonstrated that RSV vaccines, such as AREXVY, prevent RSV-related illness with more than 70% effectiveness. Data also showed that when mothers receive the RSV vaccine, it protects their babies from serious lung infections. These findings suggest that the RSV vaccine, which participants in this trial may receive, might effectively prevent RSV in young children. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi Pasteur, a Sanofi Company

Are You a Good Fit for This Trial?

This trial is for healthy infants and toddlers aged 6 to less than 24 months who attend daycare or have a sibling in the same age range. They must be born at full term or stable if premature, without significant medical support needs. Children with severe allergies, recent fevers, immunodeficiencies, contact with immunocompromised individuals, or recent receipt of certain vaccines and medications are excluded.

Inclusion Criteria

My child is between 6 months and 2 years old.

Participants who are healthy as determined by medical evaluation including medical history

Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator

Exclusion Criteria

I have never received an experimental RSV vaccine or treatment.

Attends a daycare facility with infants less than 6 months of age and unable or unwilling to suspend attendance for 28 days following study intervention

Deprived of freedom in an emergency setting or hospitalized involuntarily

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 intranasal administrations of the RSVt vaccine or placebo, 56 days apart

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 6-month safety follow-up phone call

6 months

What Are the Treatments Tested in This Trial?

Interventions

• RSVt Vaccine

Trial Overview The study tests a live-attenuated RSVt vaccine given intranasally to see how it spreads among close contacts and whether its genetic makeup remains stable after vaccination. The control group does not receive this vaccine. Participants are monitored over two doses administered 56 days apart.

How Is the Trial Designed?

Group I: RSVt Vaccine Group Experimental Treatment 1 Intervention

2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57

Group II: Control Group Placebo Group 1 Intervention

2 intranasal administrations (56 days apart) of the placebo at D01 and D57

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Citations

1. cdc.gov cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html

RSV Immunization Guidance for Infants and Young Children Early real-world data show that nirsevimab was at least 70% effective in preventing babies from being hospitalized with RSV. In clinical studies ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352396425004050

Respiratory syncytial virus (RSV) vaccine effectiveness and ... Clinical trials have demonstrated the efficacy of RSV vaccines (62.1% for ABRYSVO and 71.7% for AREXVY) against RSV-related acute respiratory illness in this ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10864603/

Efficacy and safety of respiratory syncytial virus vaccination ... In conclusion, maternal RSV vaccination is an effective and safe immunization strategy for preventing LRTI in postpartum infants, with greater efficacy observed ...

4. ecdc.europa.eu ecdc.europa.eu/en/news-events/rsv-vaccines-safe-and-effective-cochrane-review-finds

RSV vaccines safe and effective, Cochrane review finds - ECDC Vaccines for respiratory syncytial virus (RSV) reduce the risk of infection in older adults and infants, according to a new Cochrane review.

5. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7416a1.htm

Interim Evaluation of Respiratory Syncytial Virus ... The largest estimated rate reduction was observed among infants aged 0–2 months (RSV-NET: 52%, 95% CI = 49%–56%; NVSN: 45%, 95% CI = 32%–57%) ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/rsv.html

Respiratory Syncytial Virus (RSV) Vaccine Safety RSV immunizations protect people at increased risk for severe RSV disease when used according to the approved guidelines and recommendations.

7. immunize.org immunize.org/wp-content/uploads/vis/pdf/rsv.pdf

RSV (Respiratory Syncytial Virus) Vaccine V-Safe is a safety monitoring system that lets you share with CDC how you, or your dependent, feel after getting RSV vaccine.

8. mayoclinic.org mayoclinic.org/drugs-supplements/respiratory-syncytial-virus-vaccine-intramuscular-route/description/drg-20551166

Respiratory syncytial virus vaccine (intramuscular route) This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention.

9. evidence.nejm.org evidence.nejm.org/doi/abs/10.1056/EVIDoa2500026

Live-Attenuated Intranasal RSV Vaccine in Infants and Toddlers Solicited systemic reactions were reported by 79.7%, 73.2%, and 77.0% of participants post vaccination 1, and 66.7%, 66.7%, and 48.1% post ...

10. chop.edu chop.edu/vaccine-education-center/vaccine-details/rsv-vaccine-monoclonal-antibody

Respiratory Syncytial Virus (RSV): The Disease, Vaccines ... More data are needed to evaluate the safety and effectiveness of receiving additional doses. In the meantime, infants born to a person ...