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 Results 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 of Stage 1 (Phase I/IIa) was 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 were to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage evaluated 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 incorporated a Stage 2 (Phase IIa, dose-ranging design) that included 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 were randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses were performed, minimally at D07 and D28.

Conditions

Respiratory Syncytial Virus Immunization

Outcome Measures

Primary Outcomes (9)

• Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination.

  Up to 30 minutes post-primary vaccination on Day 1

• Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

  An injection site reaction was an adverse reaction (AR) at and around the injection site of the study vaccine. Injection site reactions were commonly inflammatory reactions. Solicited injection site reactions were reactions at and around the injection site of the study vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited reactions were considered to be related to the study vaccine administered.

  From Day 1 (first dose of primary vaccination) up to Day 8 (7 days post-primary vaccination on Day 1)

• Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Unsolicited Adverse Events

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.

  From Day 1 (first dose of primary vaccination) up to Day 29 (28 days post-primary vaccination on Day 1)

• Stage 1 (Sentinel and Main Cohort): Number of Participants With Medically Attended Adverse Events (MAAEs)

  An MAAE was a new-onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office or Emergency Department.

  From Day 1 (first dose of primary vaccination) up to Day 29 (28 days post-primary vaccination on Day 1)

• Stage 2: Number of Participants With Medically Attended Adverse Events

  An MAAE was a new-onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office or Emergency Department.

  From Day 1 (first dose of primary vaccination) to Day 180

• Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor was appropriate.

  From Day 1 (first dose of primary vaccination) to Day 365 (Stage 1 Sentinel and Main Cohorts); From Day 1 (first dose of primary vaccination) to Day 180 (Stage 2)

• Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Shifts From Baseline to Out-of-Range Biological Test Results

  Clinical evaluation of laboratory parameters (hematology, clinical chemistry and coagulation parameters) was performed to determine out-of-range values (below or above normal range). Number of participants with a shift from baseline to out-of-range value within 7 days after primary vaccination (Day 8) are reported. Laboratory parameters with a notable shift from baseline included: hematology: hemoglobin, white blood cells (WBC), red blood cells (RBC); clinical chemistry: blood urea nitrogen (BUN), potassium, glucose, C-reactive protein (CRP), direct bilirubin, troponin I; and coagulation parameters: partial thromboplastin time (PTT).

  From baseline (Day -14 to Day -1) up to Day 8 (7 days post-primary vaccination on Day 1)

• Stage 1 (Sentinel and Main Cohort): Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Respiratory Syncytial Virus A

  Neutralizing antibodies activity against RSV A was measured using the RSV plaque reduction neutralization test (PRNT) (micro-PRNT). RSV A serum neutralizing antibodies titers were expressed as 1/dilution.

  Day 1 (pre-primary vaccination) and Day 29 (28 days post-primary vaccination on Day 1)

• Stage 2: Geometric Mean Titers of Neutralizing Antibodies Against Respiratory Syncytial Virus A and Respiratory Syncytial Virus B

  Neutralizing antibodies activity against RSV A and RSV B was measured using the RSV PRNT (micro-PRNT). RSV A and RSV B serum neutralizing antibodies titers were expressed as 1/dilution.

  Day 1 (pre-primary vaccination) and Day 29 (28 days post-primary vaccination on Day 1)

Secondary Outcomes (10)

• Stage 1 (Booster Cohort): Number of Participants With Immediate Unsolicited Systemic Adverse Events

  Up to 30 minutes post-booster vaccination at Month 12

• Stage 1 (Booster Cohort): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

  Up to 7 days post-booster vaccination at Month 12

• Stage 1 (Booster Cohort): Number of Participants With Unsolicited Adverse Events and Medically Attended Adverse Events

  Up to 28 days post-booster vaccination at Month 12

• Stage 1 (Booster Cohort): Number of Participants With Serious Adverse Events and Adverse Events of Special Interest

  From Month 12 (first dose of booster vaccination) to Month 24

• Stage 1 (Booster Cohort): Number of Participants With Shifts From Baseline to Out-of-Range Biological Test Results

  From baseline (Month 12: Day -14 to Day -1) up to 7 days post-booster vaccination at Month 12

Study Arms (17)

Stage 1: Sentinel Cohort: RSV Vaccine Dose A1

EXPERIMENTAL

Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose A1 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Sentinel Cohort: RSV Vaccine Dose A2

EXPERIMENTAL

Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose A2 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Sentinel Cohort: RSV Vaccine Dose B1

EXPERIMENTAL

Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose B1 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Sentinel Cohort: RSV Vaccine Dose B2

EXPERIMENTAL

Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose B2 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Sentinel Cohort: RSV Vaccine Dose C1

EXPERIMENTAL

Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose C1 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Sentinel Cohort: RSV Vaccine Dose C2

EXPERIMENTAL

Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose C2 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Sentinel Cohort: Placebo

PLACEBO COMPARATOR

Participants enrolled in the Sentinel Cohort received 0.5 mL placebo matched to RSV vaccine as an IM injection on Day 1 of Stage 1.

Other: Placebo

Stage 1: Main Cohort: RSV Vaccine Dose A1

EXPERIMENTAL

Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose A1 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Main Cohort: RSV Vaccine Dose A2

EXPERIMENTAL

Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose A2 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Main Cohort: RSV Vaccine Dose B1

EXPERIMENTAL

Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose B1 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Main Cohort: RSV Vaccine Dose B2

EXPERIMENTAL

Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose B2 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Main Cohort: RSV Vaccine Dose C1

EXPERIMENTAL

Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose C1 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Main Cohort: RSV Vaccine Dose C2

EXPERIMENTAL

Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose C2 as an IM injection on Day 1 of Stage 1.

Biological: RSV vaccine candidate

Stage 1: Main Cohort: Placebo

PLACEBO COMPARATOR

Participants enrolled in the Main Cohort received 0.5 mL placebo matched to RSV vaccine as an IM injection on Day 1 of Stage 1.

Other: Placebo

Stage 2: RSV Vaccine Dose C2

EXPERIMENTAL

Participants received 0.5 mL RSV vaccine dose C2 as an IM injection on Day 1 of Stage 2.

Biological: RSV vaccine candidate

Stage 2: RSV Vaccine Dose D

EXPERIMENTAL

Participants received 0.5 mL RSV vaccine dose D as an IM injection on Day 1 of Stage 2.

Biological: RSV vaccine candidate

Stage 2: Placebo

PLACEBO COMPARATOR

Participants received 0.5 mL placebo matched to RSV vaccine as an IM injection on Day 1 of Stage 2.

Other: Placebo

Interventions

Placebo OTHER

Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection

Stage 1: Main Cohort: Placebo; Stage 1: Sentinel Cohort: Placebo; Stage 2: Placebo

RSV vaccine candidate BIOLOGICAL

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

Stage 1: Main Cohort: RSV Vaccine Dose A1; Stage 1: Main Cohort: RSV Vaccine Dose A2; Stage 1: Main Cohort: RSV Vaccine Dose B1; Stage 1: Main Cohort: RSV Vaccine Dose B2; Stage 1: Main Cohort: RSV Vaccine Dose C1; Stage 1: Main Cohort: RSV Vaccine Dose C2; Stage 1: Sentinel Cohort: RSV Vaccine Dose A1; Stage 1: Sentinel Cohort: RSV Vaccine Dose A2; Stage 1: Sentinel Cohort: RSV Vaccine Dose B1; Stage 1: Sentinel Cohort: RSV Vaccine Dose B2; Stage 1: Sentinel Cohort: RSV Vaccine Dose C1; Stage 1: Sentinel Cohort: RSV Vaccine Dose C2; Stage 2: RSV Vaccine Dose C2; Stage 2: RSV Vaccine Dose D

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 was eligible to participate if she was not pregnant or breastfeeding and:
• Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been postmenopausal for at least 1 year or surgically sterile OR
• Was 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 was eligible to participate if she was not pregnant or breastfeeding and:
• Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been 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 was 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, was 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 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
• Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
• The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

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

Related Links

• VAE00010 Plain Language Results Summary

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 5, 2026
• Results First Posted: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

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