Clinical trial NCT06727058: Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
Official title: A Phase 1/2, Randomized, Modified Double-blind, Placebo-controlled, Multi-center, Dose Escalating Study to Evaluate the Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Influenza Immunization
Keywords: pandemic influenza infection
H5 strain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-12-10
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older on the day of inclusion.
* 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.

OR

• 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.

Exclusion Criteria:

* 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.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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.

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: Presence of immediate adverse events (AEs) within 30 minutes after each/any injection
timeFrame: Within 30 minutes of any/each injections
measure: Presence of solicited injection site reactions through 7 days after each/any injection
timeFrame: Through 7 days after each/any injections
measure: Presence of solicited systemic site reactions through 7 days after each/any injection
timeFrame: Through 7 days after each/any injections
measure: Presence of unsolicited AEs through 21 days after the first injection and through 28 days after the second injection
timeFrame: Through 21 days after the first injection and through 28 days after the second injection
measure: Presence of medically attended adverse events (MAAEs) through 180 days after the last injection
timeFrame: Through 180 days after the last injection
measure: Presence of adverse events of special interest (AESIs) throughout the study
timeFrame: Throughout the study, approximately 13 months
measure: Presence of serious adverse events (SAEs) throughout the study
timeFrame: Throughout the study, approximately 13 months
measure: Presence of out-of-range biological test results (including shift from baseline values) through a maximum of 8 days after each injection
timeFrame: Through a maximum of 8 days after each injection
Secondary outcomes:
measure: Antibody titers measured by Hemagglutination Inhibition (HAI) Assay
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: Individual HAI titer ratio
timeFrame: At Day 22/Day 01, Day 43/Day 01, Day 112/Day 01, and Day 202/Day 01
measure: ≥ 4-fold increase in HAI titer [1/dilution])
timeFrame: At Day 22 or Day 43
measure: HAI titer ≥ 10 [1/dilution]
timeFrame: At day 01
measure: HAI titer ≥ 40 [1/dilution]
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: Detectable HAI titer ≥ 10 [1/dilution]
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: Antibody titers measured by Seroneutralization (SN) test
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: Individual SN titer ratio
timeFrame: Day 22/Day 01, Day 43/Day 01, Day 112/Day 01, and Day 202/Day 01
measure: SN titer ≥ 20 (1/dilution)
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: SN titer ≥ 40 (1/dilution)
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: SN titer ≥ 80 (1/dilution)
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: Detectable SN titer ≥ 10 (1/dilution)
timeFrame: At Day 01, Day 22, Day 43, Day 112, and Day 202
measure: 2-fold rise in SN titer
timeFrame: At Day 22 and Day 43
measure: 4-fold rise in SN titer
timeFrame: At Day 22 and Day 43
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Velocity Clinical Research - San Diego- Site Number : 8400013
state: California
city: DeLand
country: United States
facility: Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002
state: Florida
city: Lakeland
country: United States
facility: ARSN-Lakeland CRU- Site Number : 8400006
state: Florida
city: Largo
country: United States
facility: Accel Research Sites - St. Petersburg- Site Number : 8400004
state: Florida
city: Atlanta
country: United States
facility: Atlanta Clinical Research Center- Site Number : 8400007
state: Georgia
city: Decatur
country: United States
facility: Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003
state: Georgia
city: Bingham Farms
country: United States
facility: QUEST Research Institute- Site Number : 8400014
state: Michigan
city: Norfolk
country: United States
facility: Velocity Clinical Research - Norfolk- Site Number : 8400015
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research - Omaha- Site Number : 8400012
state: Nebraska
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Springdale- Site Number : 8400010
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - North Charleston- Site Number : 8400001
state: South Carolina
city: Sugar Land
country: United States
facility: Olympus Clinical Research - Sugar Land- Site Number : 8400009
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City- Site Number : 8400011
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research- Site Number : 8400005
state: Virginia
Study officials:
References: