Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older

NCT06727058 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: VBS00001U1111-1309-8833
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development. The duration per participant will be approximately 13 months.

Conditions

Influenza Immunization

Keywords

pandemic influenza infection; H5 strain

Outcome Measures

Primary Outcomes (8)

• Presence of immediate adverse events (AEs) within 30 minutes after each/any injection

  Number of participants experiencing immediate AEs

  Within 30 minutes of any/each injections

• Presence of solicited injection site reactions through 7 days after each/any injection

  Number of participants experiencing solicited injection site reactions

  Through 7 days after each/any injections

• Presence of solicited systemic site reactions through 7 days after each/any injection

  Number of participants experiencing solicited systemic site reactions

  Through 7 days after each/any injections

• Presence of unsolicited AEs through 21 days after the first injection and through 28 days after the second injection

  Number of participants experiencing unsolicited AEs

  Through 21 days after the first injection and through 28 days after the second injection

• Presence of medically attended adverse events (MAAEs) through 180 days after the last injection

  Number of participants experiencing MAAEs

  Through 180 days after the last injection

• Presence of adverse events of special interest (AESIs) throughout the study

  Number of participants experiencing AESIs

  Throughout the study, approximately 13 months

• Presence of serious adverse events (SAEs) throughout the study

  Number of participants experiencing SAEs

  Throughout the study, approximately 13 months

• Presence of out-of-range biological test results (including shift from baseline values) through a maximum of 8 days after each injection

  Number of participants with out-of-range biological test results

  Through a maximum of 8 days after each injection

Secondary Outcomes (14)

• Antibody titers measured by Hemagglutination Inhibition (HAI) Assay

  At Day 01, Day 22, Day 43, Day 112, and Day 202

• Individual HAI titer ratio

  At Day 22/Day 01, Day 43/Day 01, Day 112/Day 01, and Day 202/Day 01

• ≥ 4-fold increase in HAI titer [1/dilution])

  At Day 22 or Day 43

• HAI titer ≥ 10 [1/dilution]

  At day 01

• HAI titer ≥ 40 [1/dilution]

  At Day 01, Day 22, Day 43, Day 112, and Day 202

Study Arms (4)

Group 1: Low Dose Pandemic flu H5 mRNA vaccine

EXPERIMENTAL

Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)

Biological: Pandemic flu H5 mRNA vaccine

Group 2: Medium Dose Pandemic flu H5 mRNA vaccine

EXPERIMENTAL

Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)

Biological: Pandemic flu H5 mRNA vaccine

Group 3: High Dose Pandemic flu H5 mRNA vaccine

EXPERIMENTAL

Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)

Biological: Pandemic flu H5 mRNA vaccine

Group 4: Placebo

PLACEBO COMPARATOR

Participants will receive 2 injections of placebo 21 days apart (at Day 01 and Day 22)

Other: Placebo

Interventions

Placebo OTHER

Pharmaceutical Form: Liquid solution for injection Route of Administration: Intramuscular (IM)

Group 4: Placebo

Pandemic flu H5 mRNA vaccine BIOLOGICAL

Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular (IM)

Group 1: Low Dose Pandemic flu H5 mRNA vaccine; Group 2: Medium Dose Pandemic flu H5 mRNA vaccine; Group 3: High Dose Pandemic flu H5 mRNA vaccine

Eligibility Criteria

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

You may qualify if:

• A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
• 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.
• Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration.
• A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the first dose of study intervention.

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 an mRNA vaccine .
• Previous history of myocarditis, pericarditis, and/or myopericarditis.
• Known history of previous episodes of Guillain-Barré Syndrome (GBS), neuritis (including Bell's palsy), convulsions , encephalitis, transverse myelitis, and vasculitis.
• Participants with an electrocardiogram that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results.
• Self-reported thrombocytopenia, 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.
• Moderate or severe acute illness / infection (according to investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion.
• Participant who had acute infectious symptoms or a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase polymerase chain reaction (RT PCR) or antigen test in the past 10 days prior to the first visit (V)01.
• Receipt of any vaccine other than an mRNA vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine other than an mRNA vaccine in the 3 weeks following the second dose of the study intervention .
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration or planned receipt of any mRNA vaccine in the 2 months after the second dose of the study intervention.
• Participation at the time of study enrollment (or in the 4 weeks preceding study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Previous history of participation in an H5 influenza A vaccine study. This includes any influenza subtypes that contain H5 such as H5N1, H5N8, or H5N6.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (14)

Velocity Clinical Research - San Diego- Site Number : 8400013

La Mesa, California, 91942, United States

Location

Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002

DeLand, Florida, 32720, United States

Location

ARSN-Lakeland CRU- Site Number : 8400006

Lakeland, Florida, 33803, United States

Location

Accel Research Sites - St. Petersburg- Site Number : 8400004

Largo, Florida, 33777, United States

Location

Atlanta Clinical Research Center- Site Number : 8400007

Atlanta, Georgia, 30342, United States

Location

Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003

Decatur, Georgia, 30030-2627, United States

Location

QUEST Research Institute- Site Number : 8400014

Bingham Farms, Michigan, 48334, United States

Location

Velocity Clinical Research - Norfolk- Site Number : 8400015

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research - Omaha- Site Number : 8400012

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research - Springdale- Site Number : 8400010

Cincinnati, Ohio, 45246, United States

Location

Coastal Carolina Research Center - North Charleston- Site Number : 8400001

North Charleston, South Carolina, 29405, United States

Location

Olympus Clinical Research - Sugar Land- Site Number : 8400009

Sugar Land, Texas, 77479, United States

Location

Velocity Clinical Research, Salt Lake City- Site Number : 8400011

West Jordan, Utah, 84088, United States

Location

Charlottesville Medical Research- Site Number : 8400005

Charlottesville, Virginia, 22911, United States

Location

Related Links

• VBS00001 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Modified double blind (participants; sites, except for those preparing/administering study intervention; and Sponsor will be blinded). Sponsor's internal safety monitoring team will be unblinded if necessary. "Evaluation of the Safety of the sentinel cohorts will be unmasked for the Sponsor's safety Team".
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 9, 2024
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (14)