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

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

sa-mRNA vaccine Dose 1

sa-mRNA vaccine Dose 2

sa-mRNA vaccine Dose 3

sa-mRNA vaccine Dose 4

Placebo

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Vaccine, mRNA

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 . Exclusion Criteria: 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.

Sites / Locations

Nucleus Network Brisbane Clinic
Nucleus network Melbourne ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

sa-mRNA vaccine dose 1

sa-mRNA vaccine dose 2

sa-mRNA vaccine dose 3

sa-mRNA vaccine dose 4

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

Number and percentage of subjects reporting unsolicited AEs

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).

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

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

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

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

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

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

Secondary Outcome Measures

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

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

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

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

Seroconversion rate (SCR) by HAI assay

Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay

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

Full Information

NCT ID

NCT06028347

First Posted

August 31, 2023

Last Updated

October 10, 2023

Sponsor

Seqirus

1. Study Identification

Unique Protocol Identification Number

NCT06028347

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 5, 2023 (Actual)

Primary Completion Date

September 24, 2024 (Anticipated)

Study Completion Date

September 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seqirus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human

Keywords

Influenza, Vaccine, mRNA

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sa-mRNA vaccine dose 1

Arm Type

Experimental

Arm Title

sa-mRNA vaccine dose 2

Arm Type

Experimental

Arm Title

sa-mRNA vaccine dose 3

Arm Type

Experimental

Arm Title

sa-mRNA vaccine dose 4

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

sa-mRNA vaccine Dose 1

Intervention Description

self-amplifying mRNA vaccine

Intervention Type

Biological

Intervention Name(s)

sa-mRNA vaccine Dose 2

Intervention Description

self-amplifying mRNA vaccine

Intervention Type

Biological

Intervention Name(s)

sa-mRNA vaccine Dose 3

Intervention Description

self-amplifying mRNA vaccine

Intervention Type

Biological

Intervention Name(s)

sa-mRNA vaccine Dose 4

Intervention Description

self-amplifying mRNA vaccine

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Saline for injection

Primary Outcome Measure Information:

Title

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

Time Frame

up to 60 minutes or within 6 hours post vaccination

Title

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

Time Frame

Day 1 to Day 14 of each post vaccination period

Title

Number and percentage of subjects reporting unsolicited AEs

Time Frame

Day 1 to Day 43

Title

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).

Time Frame

Day 1 to Day 202

Title

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

Time Frame

Day 3 to Day 43

Title

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

Time Frame

Day 3 to Day 43

Title

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

Time Frame

Day 1, Day 22, Day 43

Title

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

Time Frame

Day 1, Day 22, Day 43

Title

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

Time Frame

Day 1, Day 22, Day 43

Title

Seroconversion rate (SCR) by HAI assay

Description

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

Time Frame

Day 1, Day 22, Day 43

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 1, Day 202

Title

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

Time Frame

Day 1, Day 202

Title

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

Time Frame

Day 202

Title

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

Time Frame

Day 202

Title

Seroconversion rate (SCR) by HAI assay

Time Frame

Day 1, Day 202

Title

Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay

Time Frame

Day 1, Day 22, Day 43, Day 202

Title

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

Time Frame

Day 1, Day 22, Day 43, Day 202

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 . Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Trial Disclosure Manager

Phone

+1 855 358 8966

Email

seqirus.clinicaltrials@seqirus.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Program Director

Organizational Affiliation

Seqirus

Official's Role

Study Director

Facility Information:

Facility Name

Nucleus Network Brisbane Clinic

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristi McLendon, MD

Phone

+61 1800 243 733

Facility Name

Nucleus network Melbourne Clinic

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christina Chang, MD

Phone

+61 390 768 900

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])).

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

http://www.seqirus.us/partnering

Influenza, Human

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial