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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06028347
• Other study ID #: V202_01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 5, 2023
• Est. completion date: September 24, 2024

Study information

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

Clinical Trial Summary

This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of one or 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 128 evaluable subjects will be enrolled in this study; n=96 receiving investigational vaccine and n=32 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: September 24, 2024
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• sa-mRNA vaccine Dose 1
self-amplifying mRNA vaccine
• sa-mRNA vaccine Dose 2
self-amplifying mRNA vaccine
• sa-mRNA vaccine Dose 3
self-amplifying mRNA vaccine
• sa-mRNA vaccine Dose 4
self-amplifying mRNA vaccine
• Placebo
Saline for injection

Locations

Country	Name	City	State
Australia	Nucleus Network Brisbane Clinic	Brisbane	Queensland
Australia	Nucleus network Melbourne Clinic	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs		Day 1 to Day 14 of each post vaccination period
Primary	Number and percentage of subjects reporting unsolicited AEs		Day 1 to Day 43
Primary	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
Primary	Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values		Day 3 to Day 43
Primary	Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments		Day 3 to Day 43
Primary	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
Primary	Number and percentage of subjects with HAI titer =1:10 and <1:10 (lower limit of quantification [LLOQ])		Day 1, Day 22, Day 43
Primary	Number and percentage of subjects with HAI titer =1:40, =1:80, =1:160 and =1:320		Day 1, Day 22, Day 43
Primary	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	Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay		Day 1, Day 202
Secondary	Number and percentage of subjects with =4-fold increase in post-vaccination HAI titer		Day 1, Day 202
Secondary	Number and percentage of subjects with HAI titer =1:10 and <1:10 (LLOQ)		Day 202
Secondary	Number and percentage of subjects with HAI titer =1:40, =1:80, =1:160 and =1:320		Day 202
Secondary	Seroconversion rate (SCR) by HAI assay		Day 1, Day 202
Secondary	Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay		Day 1, Day 22, Day 43, Day 202
Secondary	Number and percentage of subjects with =4-fold increase in post-vaccination ELLA titer		Day 1, Day 22, Day 43, Day 202