Healthy Volunteers, Human Metapneumovirus Immunization, Respiratory Syncytial Virus Immunization
Conditions
Keywords
RSV, HMPV
Brief summary
This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.
Interventions
BIOLOGICALRSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
BIOLOGICALControl Vaccine 3
Control Vaccine 3
BIOLOGICALControl Vaccine 4
Control Vaccine 4
BIOLOGICALControl Vaccine 2
Control Vaccine 2
OTHERPlacebo
Placebo
BIOLOGICALControl Vaccine 1
Control Vaccine 1
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Observer-blind: * Blinding for vaccine group assignment: participants, outcome assessors, investigators, site staff, laboratory personnel, Sponsor study staff. * No blinding for site staff who prepare and administer the study interventions. * Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohort.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 60 years or older on the day of inclusion * Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)
Exclusion criteria
* History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months * Previous history of myocarditis, pericarditis, and/or myopericarditis * Screening electrocardiogram (ECG) 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 * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Previous history of Guillain-Barré Syndrome * Any vaccine given 4 weeks before or 4 weeks after study intervention * Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine * Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration * Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months * Any screening laboratory parameter with laboratory abnormality \> Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSV A serum nAb (neutralizing antibodies) titers | At Day 1 and Day 29 | nAb titers expressed as geometric mean titers (GMTs) |
| RSV B serum nAb titers | At Day 1 and Day 29 | nAb titers expressed as GMTs |
| HMPV A serum nAb titers | At Day 1 and Day 29 | nAb titers expressed as GMTs |
| HMPV B serum nAb titers | At Day 1 and Day 29 | nAb titers expressed as GMTs |
| Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination | Within 30 minutes after vaccination | Number of participants reporting immediate unsolicited systemic AEs |
| Presence of solicited injection site and systemic reactions | For 8 days, including the day of vaccination | Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue and myalgia |
| Presence of Unsolicited AEs | For 28 days, including day of vaccination | Number of participants reporting unsolicited AEs |
| Presence of medically attended AEs (MAAEs) | Within 6 months after vaccination | Number of participants reporting MAAEs |
| Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs) | Throughout the study (approximately 12 months) | Number of participants reporting SAEs, fatal SAEs and AESIs |
| Presence of out-of-range biological test results | At Day 09 | Number of participants with biological safety assessment values out of normal range (including shift from baseline values) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination | 3, 6, 9, and 12-months post-vaccination | nAb titers expressed as geometric mean titers (GMTs) |
| RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination | 3, 6, 9, and 12 months post-vaccination | nAb titers expressed as GMTs |
| HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination | 3, 6, 9, and 12 months post-vaccination | nAb titers expressed as GMTs |
| HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination | 3, 6, 9, and 12 months post-vaccination | nAb titers expressed as GMTs |
| Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination | pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination | Ab concentration expressed as geometric mean concentrations (GMCs) |
| Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination | pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination | Ab concentration expressed as GMCs |
| Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) | Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01) | — |
| Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) | Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01) | — |
Countries
United States
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed