Respiratory Syncytial Virus InfectionPhase 1NCT06237296
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
A Phase 1 study testing RSV/hMPV mRNA LNP 1, RSV/hMPV mRNA LNP 2 and RSV mRNA LNP 1 in people with Respiratory Syncytial Virus Infection and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 17 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infection, Healthy Volunteers, Metapneumovirus Infection
- What is being tested?
- RSV/hMPV mRNA LNP 1, RSV/hMPV mRNA LNP 2 and RSV mRNA LNP 1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 23 Jan 2024to 11 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Informed consent form (ICF) has been signed and dated
Who cannot join
- 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.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States9 sites
Meridian Clinical Research- Site Number : 8400007
Binghamton, New York, 13905
Charlottesville Medical Research Center Winding River - Site Number : 8400002
Charlottesville, Virginia, 22911
Velocity Clinical Research- Site Number : 8400012
Cleveland, Ohio, 44122
Velocity Gardena Site Number : 8400011
Gardena, California, 90247
Velocity Clinical Research-Hallandale Beach- Site Number : 8400013
Hallandale, Florida, 33009
Advanced Clinical Research- Site Number : 8400005
Meridian, Idaho, 83642
Velocity Clinical Research- New Orleans Site Number : 8400016
New Orleans, Louisiana, 70119
Coastal Carolina Research Center- Site Number : 8400001
North Charleston, South Carolina, 29405
Velocity Clinical Research, Sioux City Site Number : 8400017
Sioux City, Iowa, 51106
Australia8 sites
Investigational Site Number : 0360006
Blacktown, New South Wales, 2148
Investigational Site Number : 0360002
Botany, New South Wales, 2019
Investigational Site Number : 0360001
Camberwell, Victoria, 3124
Investigational Site Number : 0360007
Canberra, 2617
Investigational Site Number : 0360008
Herston, Queensland, 4006
Investigational Site Number : 0360003
Kanwal, New South Wales, 2259
Investigational Site Number : 0360005
Morayfield, Queensland, 4506
Investigational Site Number : 0360004
Sydney, New South Wales, 2035
About this study
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
Read the detailed description
Study duration per participant is approximately 6 months.
- Being tested
- RSV/hMPV mRNA LNP 1, RSV/hMPV mRNA LNP 2, RSV mRNA LNP 1, hMPV mRNA LNP 1
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV/hMPV mRNA LNP 1Biological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV/hMPV mRNA LNP 2Biological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV mRNA LNP 1Biological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
hMPV mRNA LNP 1Biological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| RSV/hMPV mRNA / LNP 1 Group 1 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1. Receives: Biological: RSV/hMPV mRNA LNP 1 |
| RSV/hMPV mRNA / LNP 1 Group 2 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2. Receives: Biological: RSV/hMPV mRNA LNP 1 |
| RSV/hMPV mRNA / LNP 1 Group 3 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3. Receives: Biological: RSV/hMPV mRNA LNP 1 |
| RSV/hMPV mRNA / LNP 2 Group 4 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1. Receives: Biological: RSV/hMPV mRNA LNP 2 |
| RSV mRNA / LNP 1 Group 5 | Experimental | Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1. Receives: Biological: RSV mRNA LNP 1 |
| hMPV mRNA / LNP 1 Group 6 | Experimental | Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1. Receives: Biological: hMPV mRNA LNP 1 |
| RSV/hMPV mRNA / LNP 1 Group 7 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4. Receives: Biological: RSV/hMPV mRNA LNP 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of unsolicited systemic immediate adverse events (AEs)
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Measured: Within 30 minutes after vaccination
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
Measured: Within 7 days after vaccination
Presence of unsolicited AEs
Number of participants experiencing unsolicited AEs
Measured: Within 28 days after vaccination
Presence of medically attended adverse events (MAAEs)
Number of participants experiencing MAAEs
Measured: Throughout study (up to approximately 6 months)
Presence of serious adverse events (SAEs)
Throughout study (up to approximately 6 months)
Measured: Throughout study (up to approximately 6 months)
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs
Measured: Throughout study (up to approximately 6 months)
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)
Measured: Within 7 days after vaccination
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
Measured: Day 1 and Day 29
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
Measured: Day 1 and Day 29
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
Measured: Day 1 and Day 29
Secondary outcomes (5)
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
Measured: Day 1, Day 29, Day 91 and Day 181
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
Measured: Day 1, Day 29, Day 91 and Day 181
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
Measured: Day 1, Day 29, Day 91 and Day 181
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
Measured: Day 1, Day 29, Day 91 and Day 181
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
Measured: Day 1, Day 29, Day 91 and Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start23 Jan 2024
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237296
- Sponsor's protocol ID
- VAV00027
- Other IDs
- VAV00027, U1111-1295-2931
- Status last verified
- Sep 2025
- First submitted
- 23 Jan 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06237296
- Acronym / sponsor ID
- VAV00027
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study duration per participant is approximately 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| RSV/hMPV mRNA / LNP 1 Group 1 | Experimental | Biological: RSV/hMPV mRNA LNP 1Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1. |
| RSV/hMPV mRNA / LNP 1 Group 2 | Experimental | Biological: RSV/hMPV mRNA LNP 1Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2. |
| RSV/hMPV mRNA / LNP 1 Group 3 | Experimental | Biological: RSV/hMPV mRNA LNP 1Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3. |
| RSV/hMPV mRNA / LNP 2 Group 4 | Experimental | Biological: RSV/hMPV mRNA LNP 2Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1. |
| RSV mRNA / LNP 1 Group 5 | Experimental | Biological: RSV mRNA LNP 1Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1. |
| hMPV mRNA / LNP 1 Group 6 | Experimental | Biological: hMPV mRNA LNP 1Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1. |
| RSV/hMPV mRNA / LNP 1 Group 7 | Experimental | Biological: RSV/hMPV mRNA LNP 1Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Informed consent form (ICF) has been signed and dated
Key exclusion criteria (3 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV/hMPV mRNA LNP 1Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | RSV/hMPV mRNA / LNP 1 Group 1, RSV/hMPV mRNA / LNP 1 Group 2, RSV/hMPV mRNA / LNP 1 Group 3, RSV/hMPV mRNA / LNP 1 Group 7 |
| RSV/hMPV mRNA LNP 2Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | RSV/hMPV mRNA / LNP 2 Group 4 |
| RSV mRNA LNP 1Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | RSV mRNA / LNP 1 Group 5 |
| hMPV mRNA LNP 1Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | hMPV mRNA / LNP 1 Group 6 |
Primary outcome
Presence of unsolicited systemic immediate adverse events (AEs)
Time frame: Within 30 minutes after vaccination
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Presence of solicited injection site or systemic reactions
Time frame: Within 7 days after vaccination
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Presence of unsolicited AEs
Time frame: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Presence of medically attended adverse events (MAAEs)
Time frame: Throughout study (up to approximately 6 months)
Number of participants experiencing MAAEs
Presence of serious adverse events (SAEs)
Time frame: Throughout study (up to approximately 6 months)
Throughout study (up to approximately 6 months)
Presence of adverse events of special interest (AESIs)
Time frame: Throughout study (up to approximately 6 months)
Number of participants experiencing AESIs
Presence of out-of-range biological test results
Time frame: Within 7 days after vaccination
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
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
Time frame: Day 1 and Day 29
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
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
Time frame: Day 1 and Day 29
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
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
Time frame: Day 1 and Day 29
hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
5 secondary outcomes
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
Time frame: Day 1, Day 29, Day 91 and Day 181
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
Time frame: Day 1, Day 29, Day 91 and Day 181
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
Time frame: Day 1, Day 29, Day 91 and Day 181
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
Time frame: Day 1, Day 29, Day 91 and Day 181
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
Time frame: Day 1, Day 29, Day 91 and Day 181
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- VAV00027 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSV/hMPV mRNA LNP 1, RSV/hMPV mRNA LNP 2 and RSV mRNA LNP 1 in people with Respiratory Syncytial Virus Infection and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of unsolicited systemic immediate adverse events (AEs) (time frame: Within 30 minutes after vaccination). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.