Healthy Volunteers Clinical Trial
Official title:
A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment: - RSV/hMPV mRNA / LNP 1 at 3-4 different doses or, - RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or, - RSV mRNA / LNP 1 at 1 dose or, - hMPV mRNA / LNP 1 at 1 dose
| Status | Recruiting |
| Enrollment | 545 |
| Est. completion date | November 25, 2024 |
| Est. primary completion date | November 25, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: -Informed consent form (ICF) has been signed and dated Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: -Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. --The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Investigational Site Number : 0360006 | Blacktown | New South Wales |
| Australia | Investigational Site Number : 0360002 | Botany | New South Wales |
| Australia | Investigational Site Number : 0360001 | Camberwell | Victoria |
| Australia | Investigational Site Number : 0360007 | Canberra | |
| Australia | Investigational Site Number : 0360008 | Herston | Queensland |
| Australia | Investigational Site Number : 0360003 | Kanwal | New South Wales |
| Australia | Investigational Site Number : 0360005 | Morayfield | Queensland |
| Australia | Investigational Site Number : 0360004 | Sydney | New South Wales |
| United States | Meridian Clinical Research Site Number : 8400007 | Binghamton | New York |
| United States | Charlottesville Medical Research Center Winding River Site Number : 8400002 | Charlottesville | Virginia |
| United States | Velocity Clinical Research Site Number : 8400012 | Cleveland | Ohio |
| United States | Velocity Gardena Site Number : 8400011 | Gardena | California |
| United States | Velocity Clinical Research-Hallandale Beach Site Number : 8400013 | Hallandale Beach | Florida |
| United States | Advanced Clinical Research Site Number : 8400005 | Meridian | Idaho |
| United States | Velocity Clinical Research Site Number : 8400016 | Metairie | Louisiana |
| United States | Coastal Carolina Research Center Site Number : 8400001 | North Charleston | South Carolina |
| United States | Velocity Clinical Research, Sioux City Site Number : 8400017 | Sioux City | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi Pasteur, a Sanofi Company |
United States, Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Presence of unsolicited systemic immediate adverse events (AEs) | Number of participants experiencing immediate an immediate unsolicited systemic adverse event | Within 30 minutes after vaccination | |
| Primary | Presence of solicited injection site or systemic reactions | Number of participants reporting: injection site reactions: pain, erythema and swelling systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills |
Within 7 days after vaccination | |
| Primary | Presence of unsolicited AEs | Number of participants experiencing unsolicited AEs | Within 28 days after vaccination | |
| Primary | Presence of medically attended adverse events (MAAEs) | Number of participants experiencing MAAEs | Throughout study (up to approximately 6 months) | |
| Primary | Presence of serious adverse events (SAEs) | Throughout study (up to approximately 6 months) | Throughout study (up to approximately 6 months) | |
| Primary | Presence of adverse events of special interest (AESIs) | Number of participants experiencing AESIs | Throughout study (up to approximately 6 months) | |
| Primary | Presence of out-of-range biological test results | Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values) | Within 7 days after vaccination | |
| Primary | RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations | RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination | Day 1 and Day 29 | |
| Primary | RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations | RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination | Day 1 and Day 29 | |
| Primary | hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations | hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination | Day 1 and Day 29 | |
| Secondary | 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 A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 | |
| Secondary | 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 | RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 | |
| Secondary | 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 anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 | |
| Secondary | hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations | hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 | |
| Secondary | hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations | hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 |
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