Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older

NCT05639894 | Completed Phase 1 FDA Drug

• 3 other identifiers: VAE00010U1111-1271-15142023-505343-40
• Study Type: interventional
• Target: 865
• Locations: 3 countries
• Sites: 33

Brief Summary

Brief Summary of Stage 1: The purpose Stage 1 (Phase I/IIa) is to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage are to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. Brief Summary of Stage 2: The study also also incorporates a Stage 2 (Phase IIa, dose-ranging design) that includes adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants will be randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses will be performed, minimally at D07 and D28. Additional analyses may be performed as data are available.

Conditions

Respiratory Syncytial Virus Immunization

Outcome Measures

Primary Outcomes (9)

• Presence of unsolicited systemic adverse events (AEs)

  Number of participants experienciing unsolicited systemic adverse events

  Within 30 minutes after vaccination

• Presence of solicited injection site or systemic reactions

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

  Within 7 days after vaccination

• Presence of unsolicited AEs

  Number of participants experiencing unsolicited AEs

  Within 28 days after vaccination

• Presence of medically attended adverse events (MAAEs)

  Number of participants experiencing MAAEs

  Within 28 days after vaccination

• Presence of serious adverse events (SAEs)

  Number of participants experiencing SAEs

  Month 12

• Presence of adverse events of special interest (AESIs)

  Number of participants experiencing AESIs

  Month 12

• Presence of out-of-range biological test results

  Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)

  Within 7 days after vaccination

• Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1

  Nab titers pre-vaccination

  Day 1

• Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29

  Nab titers post-vaccination

  Day 29

Secondary Outcomes (13)

• Presence of immediate unsolicited systemic AEs (Stage 1)

  Within 30 minutes after vaccination

• Presence of solicited injection site or systemic reactions post-booster vaccination (Stage 1)

  Within 7 days after vaccination

• Presence of unsolicited AEs post-booster vaccination (Stage 1)

  Within 28 days after vaccination

• Presence of MAAEs (Stage 1)

  Within 28 days after vaccination

• Presence of serious adverse events (SAEs) post-booster vaccination (Stage 1)

  Throughout the booster study, approximately 12 months

Study Arms (10)

Group 1: Sentinel and Main Cohorts (Stage 1)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Biological: RSV vaccine candiate formulation 1

Group 2: Sentinel and Main Cohorts (Stage 1)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Biological: RSV vaccine candidate formulation 2

Group 3: Sentinel and Main Cohorts (Stage 1)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Biological: RSV vaccine candiate formulation 1

Group 4: Sentinel and Main Cohorts (Stage 1)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Biological: RSV vaccine candidate formulation 2

Group 5: Sentinel and Main Cohorts (Stage 1)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Biological: RSV vaccine candiate formulation 1

Group 6: Sentinel and Main Cohorts (Stage 1)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Biological: RSV vaccine candidate formulation 2

Group 7: Main, Sentinel and Booster Cohorts (Stage 1)

PLACEBO COMPARATOR

1 injection of placebo via intramuscular injection

Other: Placebo

Group 0: Phase IIa/Dose-ranging (Stage 2)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Biological: RSV vaccine candiate formulation 1

Group 1: Phase IIa/Dose-ranging (Stage 2)

EXPERIMENTAL

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Biological: RSV vaccine candidate formulation 2

Group 2: Phase 11a/Dose-ranging (Stage 2)

PLACEBO COMPARATOR

1 injection of placebo via intramuscular injection

Other: Placebo

Interventions

RSV vaccine candiate formulation 1 BIOLOGICAL

Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection

Group 0: Phase IIa/Dose-ranging (Stage 2); Group 1: Sentinel and Main Cohorts (Stage 1); Group 3: Sentinel and Main Cohorts (Stage 1); Group 5: Sentinel and Main Cohorts (Stage 1)

RSV vaccine candidate formulation 2 BIOLOGICAL

Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection

Group 1: Phase IIa/Dose-ranging (Stage 2); Group 2: Sentinel and Main Cohorts (Stage 1); Group 4: Sentinel and Main Cohorts (Stage 1); Group 6: Sentinel and Main Cohorts (Stage 1)

Placebo OTHER

Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection

Group 2: Phase 11a/Dose-ranging (Stage 2); Group 7: Main, Sentinel and Booster Cohorts (Stage 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 1 and Stage 2:
• Sentinel Cohort: 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 OR
• Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
• Main and Booster Cohorts: 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.
• Able to attend all scheduled visits and to comply with all study procedures
• Informed consent form has been signed and dated

You may not qualify if:

• 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 mRNA COVID-19 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 or bleeding disorder, contraindicating IM injection based on investigator's judgment
• 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 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 with an investigational vaccine
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• 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
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Self-reported or documented human immunodeficiency virus (HIV) detected by any FDA-approved/validated test, hepatitis B virus surface antigen (HBsAg), hepatits B core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs), or positive SARS-CoV-2 RT-PCR or antigen test

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (33)

Optimal Research Alabama Site Number : 8400032

Huntsville, Alabama, 35802, United States

Location

Aventiv Research Mesa Site Number : 8400020

Mesa, Arizona, 85210, United States

Location

CVS Health - Peoria Site Number : 8400042

Peoria, Arizona, 85381, United States

Location

CVS Health - Phoenix Site Number : 8400041

Phoenix, Arizona, 85019, United States

Location

Velocity Clinical Research - San Diego - ERN - PPDS Site Number : 8400010

La Mesa, California, 91942, United States

Location

Peninsula Research Associates Site Number : 8400013

Rolling Hills Estates, California, 90274, United States

Location

CVS Health - Thousand Oaks Site Number : 8400043

Thousand Oaks, California, 91361, United States

Location

Cenexel Research Centers of America Site Number : 8400024

Hollywood, Florida, 33024, United States

Location

Suncoast Research Associates, LLC Site Number : 8400003

Miami, Florida, 33173, United States

Location

Centricity Research - Georgia Site Number : 8400009

Rincon, Georgia, 31326, United States

Location

AES Peoria Site Number : 8400030

Peoria, Illinois, 61614, United States

Location

DM Clinical Research - Chicago Site Number : 8400027

River Forest, Illinois, 60305, United States

Location

Be Well Clinical Studies Site Number : 8400036

Lincoln, Nebraska, 68516, United States

Location

Velocity Clinical Research Site Number : 8400019

Cincinnati, Ohio, 45242, United States

Location

Velocity Clinical Research Site Number : 8400017

Cleveland, Ohio, 44122, United States

Location

Aventiv Research Columbus Site Number : 8400007

Columbus, Ohio, 43213, United States

Location

Lynn Institute of Norman Site Number : 8400023

Norman, Oklahoma, 73072, United States

Location

Velocity Clinical Research, Medford Site Number : 8400014

Medford, Oregon, 97504, United States

Location

Velocity Clinical Research - Providence Site Number : 8400006

East Greenwich, Rhode Island, 02818, United States

Location

Coastal Carolina Research Center Site Number : 8400015

North Charleston, South Carolina, 29405, United States

Location

DM Clinical Research - CyFair Site Number : 8400025

Houston, Texas, 77065, United States

Location

Be Well Clinical Studies -Round Rock Site Number : 8400038

Round Rock, Texas, 78681, United States

Location

IMA Clinical Research-San Antonio Site Number : 8400039

San Antonio, Texas, 78229, United States

Location

Martin Diagnostic Clinic Site Number : 8400026

Tomball, Texas, 77375, United States

Location

Velocity Clinical Research Site Number : 8400018

West Jordan, Utah, 84088-8865, United States

Location

Investigational Site Number : 0360003

Botany, New South Wales, 2019, Australia

Location

Investigational Site Number : 0360002

Camberwell, Victoria, 3124, Australia

Location

Investigational Site Number : 0360001

Southport, 4215, Australia

Location

Investigational Site Number : 6300004

Carolina, 984, Puerto Rico

Location

Investigational Site Number : 6300003

Guayama, 000784, Puerto Rico

Location

Investigational Site Number : 6300005

Guaynabo, 00968, Puerto Rico

Location

Investigational Site Number : 6300001

San Juan, 00909, Puerto Rico

Location

Investigational Site Number : 6300002

San Juan, 00918, Puerto Rico

Location

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sentinel Cohort: single-blind * Investigators, study staff who conduct the safety assessment, and the participant will not know which study intervention is administered * Sponsor study staff and study staff preparing/administering the study interventions and not involved with the safety evaluation will know which study intervention is administered Main and Booster Cohorts in Stage 1 and Stage 2: Modified double-blind * Investigators, study staff who conduct the safety assessment, and the participant will not know which study intervention is administered * Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential (Phase I)/ parallel (Phase IIa)

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 7, 2022
• Study Start: November 17, 2022
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

PR (5); US (25); AU (3)