Clinical trial NCT05426174: Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older
Official title: Phase I, Randomized, Modified Double-blind, Parallel-group, Active-controlled, Multi-arm, Dose-escalation Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza Immunization
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.

Detailed description: This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.

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:

  1. 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
  2. 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
* 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 administration of study intervention.
* Informed consent form has been signed and dated.

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; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration.
* Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy.
* Have any diagnosis, current or past, of autoimmune disease.
* Body mass index of 40 kg/m2 or higher.
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
* Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination.
* Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.

Primary outcomes:
measure: Number of participants with immediate adverse events
timeFrame: Within 30 minutes after vaccination
measure: Number of participants with solicited injection site or systemic reaction
timeFrame: From Day 1 to Day 8
measure: Number of participants with unsolicited adverse events
timeFrame: From Day 1 to Day 29
measure: Number of participants with serious adverse events
timeFrame: From Day 1 to Day 366
measure: Number of participants with adverse events of special interest
timeFrame: From Day 1 to Day 366
measure: Number of patients with clinically significant changes in clinical laboratory tests
timeFrame: From Day 1 to Day 8
Secondary outcomes:
measure: Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29
timeFrame: Day 1 and 29
measure: Individual Neuraminidase inhibition (NAI) titer
timeFrame: Day 1 and Day 29
measure: 2-fold and 4-fold rise in NAI antibody titers
timeFrame: From Day 1 to Day 29
measure: Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]
timeFrame: Day 1 and Day 29
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: AES - DRS - Optimal Research_Site 8400007
state: Alabama
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic, LLC_Site: 8400010
state: Arizona
city: San Diego
country: United States
facility: Optimal Research San Diego, LLC_Site: 8400009
state: California
city: Melbourne
country: United States
facility: AES - DRS - Optimal Research_Site 8400002
state: Florida
city: Peoria
country: United States
facility: AES - DRS - Optimal Research_Site 8400001
state: Illinois
city: Cincinnati
country: United States
facility: Synexus Clinical Research_Site 8400003
state: Ohio
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: