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Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

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Sanofi

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers
Influenza Immunization

Treatments

Biological: High Dose Quadrivalent Influenza Vaccine
Biological: mRNA NA vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05426174
FBP00012
U1111-1266-5326 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

233 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

233 participants in 4 patient groups

Group 1 mRNA NA: Low dose Level
Experimental group
Description:
Participants will receive a low dose of mRNA vaccine
Treatment:
Biological: mRNA NA vaccine
Group 2 mRNA NA: Medium dose level
Experimental group
Description:
Participants will receive a medium dose of mRNA vaccine
Treatment:
Biological: mRNA NA vaccine
Group 3 mRNA NA: High dose level
Experimental group
Description:
Participants will receive a high dose of mRNA vaccine
Treatment:
Biological: mRNA NA vaccine
Group 4: QIV-HD
Active Comparator group
Description:
Participants will receive QIV-HD (high dose quadrivalent influenza) vaccine
Treatment:
Biological: High Dose Quadrivalent Influenza Vaccine

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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