RSV mRNA Vaccine for Respiratory Syncytial Virus Immunization

Recruiting in Palo Alto (17 mi)

+80 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sanofi

Trial Summary

What is the purpose of this trial?

This trial tests a new RSV vaccine that uses tiny fat particles to help deliver it into the body. It aims to see if the vaccine is safe and effective in healthy adults aged 18-50 and those aged 60 and older. The vaccine works by teaching the immune system to recognize and fight RSV.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults aged 18-50 and those 60 or older can join this trial if they're not pregnant, breastfeeding, or planning to become pregnant soon. They must be able to follow the study schedule and agree to use effective contraception. People with weakened immune systems, recent RSV illness, chronic diseases affecting study participation, substance abuse issues, other vaccine receipts close to the trial period, certain medication intakes recently, or involvement in another clinical study cannot participate.

Inclusion Criteria

I am not pregnant or breastfeeding, can't have children, or will use birth control.

I am between 18 and 50 years old.

I am 60 years old or older.

Exclusion Criteria

Known or suspected congenital or acquired immunodeficiency; receipt of immunosuppressive therapy within the preceding 6 months; long-term systemic corticosteroid therapy; known systemic hypersensitivity to any of the study intervention components; history of life-threatening reaction to study interventions or products containing the same substances; allergic reaction after administration of mRNA COVID-19 vaccine; history of RSV-associated illness in the last 12 months; previous history of myocarditis, pericarditis, and/or myopericarditis; thrombocytopenia or bleeding disorder contraindicating IM injection; bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion; chronic illness that might interfere with study conduct or completion; alcohol, prescription drug, or substance abuse that might interfere with study conduct or completion; receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding or planned receipt in the 4 weeks following any study intervention administration; receipt of any mRNA vaccine in the 60 days preceding or planned receipt in the 60 days following any study intervention administration; previous vaccination against RSV with an investigational vaccine; receipt of immune globulins, blood, or blood-derived products in the past 3 months; receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw; participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure; deprived of freedom by an administrative or court order, in an emergency setting, or hospitalized involuntarily; self-reported or documented HIV, HBsAg, HBcAb, HCV Abs, or positive SARS-CoV-2 RT-PCR or antigen test; identified as an investigator, employee, or immediate family member with direct involvement in the proposed study

Treatment Details

Interventions

• Placebo (Other)
• RSV mRNA LNP CL-0059 High Dose (Virus Therapy)
• RSV mRNA LNP CL-0059 Low dose (Virus Therapy)
• RSV mRNA LNP CL-0059 Medium Dose (Virus Therapy)
• RSV mRNA LNP CL-0137 High Dose (Virus Therapy)
• RSV mRNA LNP CL-0137 Low dose (Virus Therapy)
• RSV mRNA LNP CL-0137 Medium Dose (Virus Therapy)

Trial Overview The trial is testing a new RSV mRNA vaccine candidate given as an injection at low, medium, and high doses using two different lipid nanoparticles (CL-0059 or CL-0137). Participants will be monitored for safety and how well their bodies respond to the vaccine over a year; some will get a booster shot after 12 months.

Participant Groups

Group I: Group 6: Sentinel and Main Cohorts (Stage 1) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Group II: Group 5: Sentinel and Main Cohorts (Stage 1) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Group III: Group 4: Sentinel and Main Cohorts (Stage 1) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Group IV: Group 3: Sentinel and Main Cohorts (Stage 1) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Group V: Group 2: Sentinel and Main Cohorts (Stage 1) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Group VI: Group 1: Sentinel and Main Cohorts (Stage 1) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Group VII: Group 1: Phase IIa/Dose-ranging (Stage 2) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Group VIII: Group 0: Phase IIa/Dose-ranging (Stage 2) Experimental Treatment 1 Intervention

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Group IX: Group 7: Main, Sentinel and Booster Cohorts (Stage 1) Placebo Group 1 Intervention

1 injection of placebo via intramuscular injection

Group X: Group 2: Phase 11a/Dose-ranging (Stage 2) Placebo Group 1 Intervention

1 injection of placebo via intramuscular injection

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

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