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Cancer Vaccine

RSV/hMPV mRNA / LNP 2 Group 4 for Metapneumovirus Infection

Phase 1

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study (up to approximately 6 months)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

Do I qualify?Apply below to find out

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

407 Previous Clinical Trials

6,091,436 Total Patients Enrolled

Frequently Asked Questions

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

Are numerous medical facilities conducting this study within the local area?

"Patients are being recruited at Investigational Site 0360004 in Sydney, New york; Meridian Clinical Research Site 8400007 in Binghamton, Louisiana; and Velocity Clinical Research Site 8400016 in Metairie, California among an additional 17 undisclosed locations."

Answered by AI

Is the enrollment for participants currently open in this medical study?

"As per clinicaltrials.gov, this investigation is presently enlisting participants. The trial was initially listed on January 23rd, 2024, and the latest update was made on March 7th, 2024."

Answered by AI

What is the overall patient enrollment count for this particular research investigation?

"Affirmative. Details listed on clinicaltrials.gov signify that this investigation is actively seeking participants. The initial posting date of the trial was 23rd January 2024, with the most recent update noted to be on 7th March 2024. A total of 545 patients are being sought across seventeen different locations for inclusion in this study."

Answered by AI

What are the risks associated with RSV/hMPV mRNA / LNP 1 Group 7 in terms of patient safety?

"Our group at Power rates the safety of RSV/hMPV mRNA / LNP 1 Group 7 as a level 1 on our scale due to being in Phase 1, indicating minimal existing data supporting both safety and effectiveness."

Answered by AI

What is the primary objective of this research endeavor?

"The primary objective of this study, to be assessed on Day 1 and Day 29, is the identification of abnormal results in biological tests. Secondary endpoints involve assessing RSV B serum nAb levels before vaccination (D01), at 28 days (D29), after 3 months (D91), and following 6 months (D181) post-vaccination using the monovalent RSV formulation. This includes evaluating pre-vaccination, day 28, month 3, and month 6 RSV A serum anti-F IgG antibody titers with the same vaccine formulation as well as hMPV A serum"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older

2024. "Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06237296.

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