Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251024
• Other study ID #: VAE00017
• Secondary ID: U1111-1271-1514V
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2024
• Est. completion date: February 18, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study duration per participant:

6 months.

Treatment Duration:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: February 18, 2025
• Est. primary completion date: February 18, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections

Intervention

Biological:
• RSV vaccine candidate
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
• Placebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Locations

Country	Name	City	State
Australia	Investigational Site Number : 0360003	Botany	New South Wales
Australia	Investigational Site Number : 0360002	Camberwell	Victoria
Australia	Investigational Site Number : 0360005	Norwood
Australia	Investigational Site Number : 0360004	Sippy Downs	Queensland
Australia	Investigational Site Number : 0360001	Southport	Queensland
Dominican Republic	Investigational Site Number : 2140001	Santo Domingo
Dominican Republic	Investigational Site Number : 2140002	Santo Domingo
Honduras	Investigational Site Number : 3400001	San Pedro Sula
Honduras	Investigational Site Number : 3400002	Tegucugalpa

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Australia,  Dominican Republic,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) = 14 days after vaccination	Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) = 14 days after vaccination	= 14 days after vaccination
Secondary	Presence of the first episode of RSV-ARD (RSV A and/or RSV B) = 14 days after vaccination	Number of participants experiencing RSV-ARD (RSV A and/or RSV B) = 14 days after vaccination	= 14 days after vaccination
Secondary	Presence of the first episode of RSV MAARD (RSV A and/or RSV B) = 14 days after vaccination	Number of participants experiencing RSV-MAARD (RSV A and/or RSV B) = 14 days after vaccination	= 14 days after vaccination
Secondary	Presence of the first episode of RSV LRTD (RSV A) occurring = 14 days after vaccination)	Number of participants experiencing RSV-LRTD (RSV A) = 14 days after vaccination	= 14 days after vaccination
Secondary	Presence of the first episode of RSV LRTD (RSV B) occurring = 14 days after vaccination	Number of participants experiencing RSV-LRTD (RSV B) = 14 days after vaccination	= 14 days after vaccination
Secondary	Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group	Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by age group	= 14 days after vaccination
Secondary	Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities	Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline comorbidities	= 14 days after vaccination
Secondary	Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status	Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline frailty status	= 14 days after vaccination
Secondary	Presence of hospitalization due to RSV-ARD and/or RSV-LRTD	Number of participants hospitalized due to RSV-ARD and/or RSV-LRTD	= 14 days after vaccination
Secondary	Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)	Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)	= 14 days after vaccination
Secondary	Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)	Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)	= 14 days after vaccination
Secondary	Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring = 14 days after vaccination	Number of participants experiencing severe RSV-LRTD (RSV A and/or B and by each one)	= 14 days after vaccination
Secondary	RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Day 1 and Day 29
Secondary	RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Day 1 and Day 29
Secondary	Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Day 1 and Day 29
Secondary	RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	Month 6
Secondary	RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	Month 6
Secondary	Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset	Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset	Month 6
Secondary	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	Within 7 days after primary vaccination
Secondary	Presence of unsolicited immediate systemic adverse events (AEs)	Number of participants experiencing an unsolicited immediate systemic adverse event	Within 30 minutes after primary vaccination
Secondary	Presence of unsolicited AEs	Number of participants experiencing unsolicited AEs	Within 28 days after primary vaccination
Secondary	Presence of serious adverse events (SAEs)	Number of participants experiencing SAEs	Throughout study (approximately 6 months)
Secondary	Presence of medically attended adverse events (MAAEs)	Number of participants experiencing MAAEs	Throughout study (approximately 6 months)
Secondary	Presence of adverse events of special interest (AESIs)	Number of participants experiencing AESIs	Throughout study (approximately 6 months)