Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults

NCT06028347 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: V202_01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults. Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo. The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).

Conditions

Influenza, Human

Keywords

Influenza; Vaccine; mRNA

Outcome Measures

Primary Outcomes (10)

• Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions

  up to 60 minutes or within 6 hours post vaccination

• Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs

  Day 1 to Day 14 of each post vaccination period

• Number and percentage of subjects reporting unsolicited AEs

  Day 1 to Day 43

• Number and percentage of subjects reporting AEs leading to study withdrawal, Adverse Events of Special Interest (AESIs), medically attended AEs (MAAEs), and serious adverse events (SAEs).

  Day 1 to Day 202

• Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values

  Day 3 to Day 43

• Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments

  Day 3 to Day 43

• Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay

  Day 1, Day 22, Day 43

• Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ])

  Day 1, Day 22, Day 43

• Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320

  Day 1, Day 22, Day 43

• Seroconversion rate (SCR) by HAI assay

  SCR defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in post-vaccination

  Day 1, Day 22, Day 43

Secondary Outcomes (7)

• Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay

  Day 1, Day 202

• Number and percentage of subjects with ≥4-fold increase in post-vaccination HAI titer

  Day 1, Day 202

• Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (LLOQ)

  Day 202

• Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320

  Day 202

• Seroconversion rate (SCR) by HAI assay

  Day 1, Day 202

Study Arms (4)

sa-mRNA vaccine dose 1

EXPERIMENTAL

Biological: sa-mRNA vaccine Dose 1

sa-mRNA vaccine dose 2

EXPERIMENTAL

Biological: sa-mRNA vaccine Dose 2

sa-mRNA vaccine dose 3

EXPERIMENTAL

Biological: sa-mRNA vaccine Dose 3

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

sa-mRNA vaccine Dose 1 BIOLOGICAL

self-amplifying mRNA vaccine

sa-mRNA vaccine dose 1

sa-mRNA vaccine Dose 2 BIOLOGICAL

self-amplifying mRNA vaccine

sa-mRNA vaccine dose 2

sa-mRNA vaccine Dose 3 BIOLOGICAL

self-amplifying mRNA vaccine

sa-mRNA vaccine dose 3

Placebo BIOLOGICAL

Saline for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
• Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
• Individuals who can comply with study procedures including follow-up .

You may not qualify if:

• Female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study.
• Male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner.
• Progressive, unstable, or uncontrolled clinical conditions
• Known hypersensitivity or allergy to any study vaccine component
• Known history of Guillain-Barré syndrome or other demyelinating disease
• Condition representing a contraindication to vaccination or blood draw
• Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
• Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
• Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
• Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (2)

Nucleus Network Brisbane Clinic

Brisbane, Queensland, 4006, Australia

Location

Nucleus network Melbourne Clinic

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Program Director

  Seqirus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: October 5, 2023
• Primary Completion: October 13, 2024
• Study Completion: October 13, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
• Access Criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.

Locations

AU (2)