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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06237296




Registration number
NCT06237296
Ethics application status
Date submitted
23/01/2024
Date registered
1/02/2024
Date last updated
3/06/2024

Titles & IDs
Public title
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
Scientific 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.
Secondary ID [1] 0 0
VAV00027
Secondary ID [2] 0 0
VAV00027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infection 0 0
Healthy Volunteers 0 0
Metapneumovirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RSV/hMPV mRNA LNP 1
Other interventions - RSV/hMPV mRNA LNP 2
Other interventions - RSV mRNA LNP 1
Other interventions - hMPV mRNA LNP 1

Experimental: RSV/hMPV mRNA / LNP 1 Group 1 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.

Experimental: RSV/hMPV mRNA / LNP 1 Group 2 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.

Experimental: RSV/hMPV mRNA / LNP 1 Group 3 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.

Experimental: RSV/hMPV mRNA / LNP 2 Group 4 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.

Experimental: RSV mRNA / LNP 1 Group 5 - Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.

Experimental: hMPV mRNA / LNP 1 Group 6 - Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.

Experimental: RSV/hMPV mRNA / LNP 1 Group 7 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.


Other interventions: RSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Other interventions: RSV/hMPV mRNA LNP 2
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Other interventions: RSV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Other interventions: hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of unsolicited systemic immediate adverse events (AEs)
Timepoint [1] 0 0
Within 30 minutes after vaccination
Primary outcome [2] 0 0
Presence of solicited injection site or systemic reactions
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Presence of unsolicited AEs
Timepoint [3] 0 0
Within 28 days after vaccination
Primary outcome [4] 0 0
Presence of medically attended adverse events (MAAEs)
Timepoint [4] 0 0
Throughout study (up to approximately 6 months)
Primary outcome [5] 0 0
Presence of serious adverse events (SAEs)
Timepoint [5] 0 0
Throughout study (up to approximately 6 months)
Primary outcome [6] 0 0
Presence of adverse events of special interest (AESIs)
Timepoint [6] 0 0
Throughout study (up to approximately 6 months)
Primary outcome [7] 0 0
Presence of out-of-range biological test results
Timepoint [7] 0 0
Within 7 days after vaccination
Primary outcome [8] 0 0
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
Timepoint [8] 0 0
Day 1 and Day 29
Primary outcome [9] 0 0
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
Timepoint [9] 0 0
Day 1 and Day 29
Primary outcome [10] 0 0
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
Timepoint [10] 0 0
Day 1 and Day 29
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 1, Day 29, Day 91 and Day 181

Eligibility
Key inclusion criteria
-Informed consent form (ICF) has been signed and dated
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/11/2024
Actual
Sample size
Target
545
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360006 - Blacktown
Recruitment hospital [2] 0 0
Investigational Site Number : 0360002 - Botany
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Kanwal
Recruitment hospital [4] 0 0
Investigational Site Number : 0360004 - Sydney
Recruitment hospital [5] 0 0
Investigational Site Number : 0360008 - Herston
Recruitment hospital [6] 0 0
Investigational Site Number : 0360005 - Morayfield
Recruitment hospital [7] 0 0
Investigational Site Number : 0360001 - Camberwell
Recruitment hospital [8] 0 0
Investigational Site Number : 0360007 - Canberra
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2035 - Sydney
Recruitment postcode(s) [5] 0 0
4006 - Herston
Recruitment postcode(s) [6] 0 0
4506 - Morayfield
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
2617 - Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT06237296
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06237296