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Cancer Vaccine

mRNA Vaccine for Respiratory Syncytial Virus

Phase 1
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study (up to approximately 6 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new vaccine to prevent lower respiratory tract diseases caused by respiratory syncytial virus and human metapneumovirus in older adults. Participants will receive one injection of the

Who is the study for?
This trial is for healthy adults aged 18-49 and those 60 or older. Participants must have signed a consent form. They can't join if they have any health issues that might affect the study's results, as judged by the study leader.
What is being tested?
The trial tests an experimental mRNA vaccine designed to prevent lung infections caused by two viruses: RSV and hMPV. Participants will receive one intramuscular injection of various doses of this vaccine in different formulations.
What are the potential side effects?
Possible side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever, fatigue, headache, muscle pain, chills or feeling unwell.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study (up to approximately 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study (up to approximately 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Presence of adverse events of special interest (AESIs)
Presence of medically attended adverse events (MAAEs)
Presence of out-of-range biological test results
+7 more
Secondary study objectives
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: hMPV mRNA / LNP 1 Group 6Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.
Group II: RSV/hMPV mRNA / LNP 2 Group 4Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.
Group III: RSV/hMPV mRNA / LNP 1 Group 7Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.
Group IV: RSV/hMPV mRNA / LNP 1 Group 3Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.
Group V: RSV/hMPV mRNA / LNP 1 Group 2Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.
Group VI: RSV/hMPV mRNA / LNP 1 Group 1Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.
Group VII: RSV mRNA / LNP 1 Group 5Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
422 Previous Clinical Trials
6,112,544 Total Patients Enrolled
~46 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
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