Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

NCT06134648
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Phase
Phase 1/Phase 2
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Recruitment status
Completed
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Participants
646
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2023-11-01
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Number of sites
13
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Summary
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
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Short title
Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
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Official title
A Phase I/IIa, Randomized, Observer-blind Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an RSV/hMPV Vaccine, in Adult Participants Aged 60 Years and Older
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2026-02-27
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First posted
2023-11-18
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Registry last updated
2026-03-12
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Primary completion date
2026-02-27
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Start date
2023-11-01
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Actual participants
646
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Participants
646
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
13
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06134648
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ClinicalTrials.gov ID
NCT06134648
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Prevention
Masking
Quadruple masking
Masking description
Sentinel, Main, and Booster Cohorts: observer-blind; for safety evaluation purposes, the Sponsor will be unblinded * Investigators, laboratory personnel, and participants will be blinded * Sponsor study staff and study staff preparing/administering the study interventions will be unblinded
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Presence of unsolicited systemic immediate adverse events (AEs)

    Timeframe: Within 30 minutes after primary vaccination

    Number of participants experiencing immediate an immediate unsolicited systemic adverse event

  2. Presence of solicited injection site or systemic reactions

    Timeframe: Within 7 days after primary vaccination

    Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills

  3. Presence of unsolicited AEs

    Timeframe: Within 28 days after vaccination

    Number of participants experiencing unsolicited AEs

  4. Presence of medically attended adverse events (MAAEs)

    Timeframe: Up to 6 months after primary injection

    Number of participants experiencing MAAEs

  5. Presence of serious adverse events (SAEs)

    Timeframe: Up to 6 months after primary injection

    Number of participants experiencing SAEs

  6. Presence of adverse events of special interest (AESIs)

    Timeframe: Up to 6 months after primary injection

    Number of participants experiencing AESIs

  7. Presence of related SAEs

    Timeframe: Throughout study (approximately 24 months)

    Number of participants experiencing related SAEs

  8. Presence of related AESIs

    Timeframe: Throughout study (approximately 24 months)

    Number of participants experiencing related AESIs

  9. Presence of fatal SAEs

    Timeframe: Throughout study (approximately 24 months)

    Number of participants experiencing fatal SAEs

  10. Presence of out-of-range biological test results

    Timeframe: 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)

  11. RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)

    Timeframe: Day 1 and Day 29

    RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29)

  12. hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)

    Timeframe: Day 1 and Day 29

    hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29)

  1. RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)

    Timeframe: Day 1 and Day 29

    RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination

  2. RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)

    Timeframe: Day 1 and Day 29

    RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination

  3. hMPV serum nAb titers at pre vaccination (D01), 28 days post-primary vaccination (D29)

    Timeframe: Day 1 and Day 29

    hMPV serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination

  4. RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

  5. RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

  6. RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

  7. hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

  8. hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination

  9. RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination

  10. RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination

  11. RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination

  12. hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination

  13. hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination

    Timeframe: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

    hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Healthy volunteers
Yes

  • Aged 60 years or older on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential.
  • Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.

Participants are excluded from the study if any of the following criteria apply:

  • Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. Persons living with stable human immunodeficiency virus (HIV) are not excluded
  • Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine
  • History of RSV and/or hMPV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
  • Previous history of myocarditis, pericarditis, and/or myopericarditis
  • Screening electrocardiogram that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
  • Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injection based on investigator's judgment
  • Receipt of anticoagulants in the 3 weeks preceding inclusion
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
  • History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved
  • Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
  • Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
  • Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Sources for eligibility
clinicaltrials.gov

  • Collaborative Neuroscience Research Site Number : 8400017Los Alamitos, United States
  • Matrix Clinical Research Site Number : 8400011Los Angeles, United States
  • Peninsula Research Associates Site Number : 8400001Rolling Hills Estates, United States
  • Suncoast Research Associates, LLC Site Number : 8400002Miami, United States
  • AMR Chicago, Oakbrook Terrace Site Number : 8400019Oakbrook Terrace, United States
  • Velocity Clinical Research, Sioux City Site Number : 8400012Sioux City, United States
  • AMR Lexington Site Number : 8400008Lexington, United States
  • AMR Kansas City Site Number : 8400014Kansas City, United States
  • AMR Knoxville Site Number : 8400010Knoxville, United States
  • DM Clinical Research - Tomball Site Number : 8400004Tomball, United States
  • Investigational Site Number : 6300002Guayama, Puerto Rico
  • Investigational Site Number : 6300001San Juan, Puerto Rico
  • Investigational Site Number : 6300003San Juan, Puerto Rico
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1287-8547
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)