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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05426174
• Other study ID #: FBP00012
• Secondary ID: U1111-1266-5326
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2022
• Est. completion date: January 3, 2024

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• mRNA NA vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
• High Dose Quadrivalent Influenza Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Locations

Country	Name	City	State
United States	Synexus Clinical Research_Site 8400003	Cincinnati	Ohio
United States	AES - DRS - Optimal Research_Site 8400007	Huntsville	Alabama
United States	AES - DRS - Optimal Research_Site 8400002	Melbourne	Florida
United States	AES - DRS - Optimal Research_Site 8400001	Peoria	Illinois
United States	Central Phoenix Medical Clinic, LLC_Site: 8400010	Phoenix	Arizona
United States	Optimal Research San Diego, LLC_Site: 8400009	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with immediate adverse events	Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination	Within 30 minutes after vaccination
Primary	Number of participants with solicited injection site or systemic reaction		From Day 1 to Day 8
Primary	Number of participants with unsolicited adverse events	Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions	From Day 1 to Day 29
Primary	Number of participants with serious adverse events	Serious adverse events are collected throughout the study	From Day 1 to Day 366
Primary	Number of participants with adverse events of special interest	Adverse events of special interest are collected throughout the study	From Day 1 to Day 366
Primary	Number of patients with clinically significant changes in clinical laboratory tests	Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen	From Day 1 to Day 8
Secondary	Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29	Antibody are expressed as GMTs at baseline and post-baseline	Day 1 and 29
Secondary	Individual Neuraminidase inhibition (NAI) titer	Antibody titers are expressed as GMTs at baseline and post-baseline	Day 1 and Day 29
Secondary	2-fold and 4-fold rise in NAI antibody titers	Expressed as percentage post-baseline	From Day 1 to Day 29
Secondary	Percentage of participants with detectable antibody titers greater than or equal to (=) 10 [1/dil]	Expressed as percentage at baseline and post-baseline	Day 1 and Day 29