Clinical trial NCT06028347: Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
Official title: Phase 1, Randomized, Placebo-Controlled, Observer Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Investigational Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza, Human
Keywords: Influenza
Vaccine
mRNA
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. 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.
3. Progressive, unstable, or uncontrolled clinical conditions
4. Known hypersensitivity or allergy to any study vaccine component
5. Known history of Guillain-Barré syndrome or other demyelinating disease
6. Condition representing a contraindication to vaccination or blood draw
7. Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
8. Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
9. Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
10. Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.

Primary outcomes:
measure: Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions
timeFrame: up to 60 minutes or within 6 hours post vaccination
measure: Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs
timeFrame: Day 1 to Day 14 of each post vaccination period
measure: Number and percentage of subjects reporting unsolicited AEs
timeFrame: Day 1 to Day 43
measure: 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).
timeFrame: Day 1 to Day 202
measure: Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values
timeFrame: Day 3 to Day 43
measure: Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments
timeFrame: Day 3 to Day 43
measure: Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
timeFrame: Day 1, Day 22, Day 43
measure: Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ])
timeFrame: Day 1, Day 22, Day 43
measure: Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
timeFrame: Day 1, Day 22, Day 43
measure: Seroconversion rate (SCR) by HAI assay
timeFrame: Day 1, Day 22, Day 43
Secondary outcomes:
measure: Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
timeFrame: Day 1, Day 202
measure: Number and percentage of subjects with ≥4-fold increase in post-vaccination HAI titer
timeFrame: Day 1, Day 202
measure: Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (LLOQ)
timeFrame: Day 202
measure: Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
timeFrame: Day 202
measure: Seroconversion rate (SCR) by HAI assay
timeFrame: Day 1, Day 202
measure: Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay
timeFrame: Day 1, Day 22, Day 43, Day 202
measure: Number and percentage of subjects with ≥4-fold increase in post-vaccination ELLA titer
timeFrame: Day 1, Day 22, Day 43, Day 202
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Nucleus Network Brisbane Clinic
state: Queensland
city: Melbourne
country: Australia
facility: Nucleus network Melbourne Clinic
state: Victoria
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References: