Clinical trial NCT06251024: Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older
Official title: A Phase IIb, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an RSV Vaccine Candidate in Adult Participants 60 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infection
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 4541
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, multi-center, case driven
Primary purpose: PREVENTION

Brief summary: The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV.

The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

Detailed description: Study duration per participant:

6 months.

Treatment Duration:

1 IM injection. Participants will be followed for approximately 6 months post- vaccination.

Eligibility criteria: Inclusion Criteria:

* 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. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile.
* Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion.

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

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* 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 an mRNA vaccine
* History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
* Previous history of myocarditis, pericarditis, and/or myopericarditis
* Thrombocytopenia, contraindicating IM injection based on investigator's judgment
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
* 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
* Receipt of any vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any 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 with a licensed or investigational vaccine or planned receipt during study participation, of vaccination against RSV with a licensed or investigational vaccine other than the study vaccine
* 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 Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
timeFrame: ≥ 14 days after vaccination
Secondary outcomes:
measure: Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination
timeFrame: ≥ 14 days after vaccination
measure: Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination
timeFrame: ≥ 14 days after vaccination
measure: Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination)
timeFrame: ≥ 14 days after vaccination
measure: Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 14 days after vaccination
timeFrame: ≥ 14 days after vaccination
measure: Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group
timeFrame: ≥ 14 days after vaccination
measure: Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities
timeFrame: ≥ 14 days after vaccination
measure: Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status
timeFrame: ≥ 14 days after vaccination
measure: Presence of hospitalization due to RSV-ARD and/or RSV-LRTD
timeFrame: ≥ 14 days after vaccination
measure: Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)
timeFrame: ≥ 14 days after vaccination
measure: Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)
timeFrame: ≥ 14 days after vaccination
measure: Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccination
timeFrame: ≥ 14 days after vaccination
measure: RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
timeFrame: Day 1 and Day 29
measure: RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
timeFrame: Day 1 and Day 29
measure: Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
timeFrame: Day 1 and Day 29
measure: RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
timeFrame: Month 6
measure: RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
timeFrame: Month 6
measure: Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset
timeFrame: Month 6
measure: Presence of solicited injection site or systemic reactions
timeFrame: Within 7 days after primary vaccination
measure: Presence of unsolicited immediate systemic adverse events (AEs)
timeFrame: Within 30 minutes after primary vaccination
measure: Presence of unsolicited AEs
timeFrame: Within 28 days after primary vaccination
measure: Presence of serious adverse events (SAEs)
timeFrame: Throughout study (approximately 6 months)
measure: Presence of medically attended adverse events (MAAEs)
timeFrame: Throughout study (approximately 6 months)
measure: Presence of adverse events of special interest (AESIs)
timeFrame: Throughout study (approximately 6 months)
Other outcomes:
Locations:
city: Botany
country: Australia
facility: Investigational Site Number : 0360003
state: New South Wales
city: Sippy Downs
country: Australia
facility: Investigational Site Number : 0360004
state: Queensland
city: Southport
country: Australia
facility: Investigational Site Number : 0360001
state: Queensland
city: Camberwell
country: Australia
facility: Investigational Site Number : 0360002
state: Victoria
city: Norwood
country: Australia
facility: Investigational Site Number : 0360005
city: Concepcion
country: Chile
facility: Investigational Site Number : 1520006
state: Biobío
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
city: Santiago
country: Chile
facility: Investigational Site Number : 1520008
city: Aguazul
country: Colombia
facility: Investigational Site Number : 1700004
city: Barranquilla
country: Colombia
facility: Investigational Site Number : 1700002
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700006
city: Cali
country: Colombia
facility: Investigational Site Number : 1700007
city: Girardot
country: Colombia
facility: Investigational Site Number : 1700003
city: Ibague
country: Colombia
facility: Investigational Site Number : 1700005
city: Quindio
country: Colombia
facility: Investigational Site Number : 1700001
city: Santo Domingo
country: Dominican Republic
facility: Investigational Site Number : 2140001
city: Santo Domingo
country: Dominican Republic
facility: Investigational Site Number : 2140002
city: San Pedro Sula
country: Honduras
facility: Investigational Site Number : 3400001
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400003
city: Tegucugalpa
country: Honduras
facility: Investigational Site Number : 3400002
city: Leon
country: Mexico
facility: Investigational Site Number : 4840002
state: Guanajuato
city: Queretaro
country: Mexico
facility: Investigational Site Number : 4840003
Study officials:
References: