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Virus Therapy

RSV mRNA Vaccine for Respiratory Syncytial Virus Immunization

Phase 1 & 2
Recruiting
Research Sponsored by Sanofi
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 month 12
Awards & highlights

Study Summary

This trial tests a vaccine for RSV in adults and seniors, assessing safety and immunity at 3 doses and with 2 different lipid nanoparticles. Boosters will be given 12 months later in some participants. Study period is 12-24 months.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain and swelling; flu-like symptoms such as fever and fatigue; allergic reactions; muscle pains; headaches. The severity of these side effects varies from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1
Presence of adverse events of special interest (AESIs)
+6 more
Secondary outcome measures
GMTs of RSV-A serum nAb post-booster vaccination (Stage 1)
GMTs of serum anti-F IgG Ab titers post-booster vaccination (Stage 1)
GMTs of serum anti-F IgG Ab titers post-vaccination (Stage 2)
+10 more

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 6: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
Group II: Group 5: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
Group III: Group 4: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Group IV: Group 3: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Group V: Group 2: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Group VI: Group 1: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Group VII: Group 1: Phase IIa/Dose-ranging (Stage 2)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Group VIII: Group 0: Phase IIa/Dose-ranging (Stage 2)Experimental Treatment1 Intervention
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Group IX: Group 7: Main, Sentinel and Booster Cohorts (Stage 1)Placebo Group1 Intervention
1 injection of placebo via intramuscular injection
Group X: Group 2: Phase 11a/Dose-ranging (Stage 2)Placebo Group1 Intervention
1 injection of placebo via intramuscular injection

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,190 Total Patients Enrolled
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,091,191 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,049 Total Patients Enrolled

Media Library

RSV mRNA LNP CL-0059 High Dose (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05639894 — Phase 1 & 2
Respiratory Syncytial Virus Immunization Research Study Groups: Group 2: Sentinel and Main Cohorts (Stage 1), Group 1: Sentinel and Main Cohorts (Stage 1), Group 3: Sentinel and Main Cohorts (Stage 1), Group 7: Main, Sentinel and Booster Cohorts (Stage 1), Group 4: Sentinel and Main Cohorts (Stage 1), Group 5: Sentinel and Main Cohorts (Stage 1), Group 1: Phase IIa/Dose-ranging (Stage 2), Group 2: Phase 11a/Dose-ranging (Stage 2), Group 0: Phase IIa/Dose-ranging (Stage 2), Group 6: Sentinel and Main Cohorts (Stage 1)
Respiratory Syncytial Virus Immunization Clinical Trial 2023: RSV mRNA LNP CL-0059 High Dose Highlights & Side Effects. Trial Name: NCT05639894 — Phase 1 & 2
RSV mRNA LNP CL-0059 High Dose (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639894 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial still open?

"Clinicaltrials.gov confirms that this medical trial is persistently seeking patients, whose initial appearance was on November 17th 2022 and who have been included in the most recent update of December 2nd 2022."

Answered by AI

How many participants is this study allowing to take part?

"Affirmative. Clinicaltrials.gov reveals that this study, which was posted on November 17th 2022, is actively seeking participants. 790 patients are sought from a single medical center."

Answered by AI

What fundamental goals is this research endeavor attempting to achieve?

"According to the trial sponsor, Sanofi, the primary outcome for this study will be Serious Adverse Events (SAEs) reported in 28 days after vaccination. Additionally, secondary outcomes of interest include injection site reactions like pain and swelling; systemic reactions such as fever or headache; out-of-range biological test results post booster vaccination; and GMTs of serum anti-F IgG antibody titers pre-vaccination, at 28 days, 3 months post primary vaccine dose, 6 months post primary vaccine dose and 12 months post primary vaccine dose."

Answered by AI

Who else is applying?

What site did they apply to?
CVS Health - Peoria-Site Number:8400042
Martin Diagnostic Clinic-Site Number:8400026
Aventiv Research Mesa Site Number : 8400020
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I want to keep healthy. I’ve tried other pain meds. To help find RSV vaccine that are effective for the elderly.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
2022. "Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639894.
~327 spots leftby Apr 2025
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