Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults

NCT ID: NCT03880474

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2020-01-21

Brief Summary

A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults aged 18 years and over. To assess the effect of MVA-NP+M1 on the reduction of laboratory confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV) in adults

Detailed Description

This is a Phase 2b, multicentre, randomised, single-blind study in up to 6000 adults to compare the efficacy, safety and immunogenicity of MVA-NP+M1 when given as an adjunct to a standard, licensed adult dose of QIV. The study will be conducted on an outpatient basis and will run over two consecutive influenza seasons. It is aimed to recruit 2200 participants in Season 1 and 2800-3800 participants in Season 2.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MVA-NP+M1

Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.)

Group Type: EXPERIMENTAL

MVA-NP+M1

Intervention Type: BIOLOGICAL

Trial Vaccine

Saline Placebo

Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%)

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Sodium Chloride Placebo

Interventions

MVA-NP+M1

Trial Vaccine

Intervention Type: BIOLOGICAL

Saline

Sodium Chloride Placebo

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

• Healthy male or female adults aged 18 years and over
• Receipt of a standard-dose licensed influenza QIV vaccine on the day of, or within 28 days prior to, randomisation
• A female participant is eligible for this study if she is not pregnant or breast feeding and one of the following:

1. Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year)

2. Of childbearing potential but agrees to practice effective contraception 8 weeks post-vaccination and has a negative urine pregnancy test pre-vaccination. Acceptable methods of contraception include one or more of the following:

i. Male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for the female participant ii. Implants of levonorgestrel iii. Injectable progestogen iv. An intrauterine device with a documented failure rate of <1% v. Oral contraceptives vi. Double barrier methods including diaphragm or condom vii. Abstinence as long as it is line with the usual and preferred lifestyle of the participant

• Participant is willing and has capacity to provide written informed consent for participation in the study (in the Investigator's opinion)
• Able and willing (in the Investigator's opinion) to comply with all study requirements
• Willing to allow the Investigators to discuss the participant's medical history with their healthcare provider
• Present and able to visit the clinic in the event of an ILI episode during the influenza season

Exclusion Criteria

• Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigator, would either put the participant at risk because of participation in the study, or may influence the result of the study
• Receipt of any investigational product within 6 months prior to study, or prior participation in a clinical study of any Influenza vaccine and agreement not to participate in another clinical study for the duration of study follow-up
• Prior receipt of an investigational vaccine likely to impact on interpretation of the study data
• Active infection with HIV, Hepatitis B or Hepatitis C (from patient history or medical records)
• History of severe allergic reactions (e.g. anaphylaxis)
• History of auto-immune disease e.g. Guillain-Barré syndrome
• Not willing to comply with study procedures
• Immunosuppressed or taking immunosuppressive medications
• Use of warfarin or other blood thinning medications (aspirin is acceptable)
• Tattoos or birthmarks at the vaccination site
• Participant bruises easily, has haematoma or keloid scarring
• Receipt of a licenced inactivated vaccine (e.g. pneumococcal vaccine) within 2 weeks prior to vaccination
• Receipt of an off licensed live vaccine (e.g. herpes zoster vaccine) within 4 weeks prior to vaccination

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Network Services (CNS) Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Barinthus Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Vandeleur, MD

Role: PRINCIPAL_INVESTIGATOR

Paratus Clinical Pty Ltd

Locations

Paratus Clinical Pty Ltd

Blacktown, New South Wales, Australia

Genesis Research Services

Broadmeadow, New South Wales, Australia

Paratus Clinical Pty Ltd

Kanwal, New South Wales, Australia

Scientia Clinical Research

Sydney, New South Wales, Australia

University of Sunshine Coast (USC)

Morayfield, Queensland, Australia

University of Sunshine Coast (USC)

Sippy Downs, Queensland, Australia

Mater Research

South Brisbane, Queensland, Australia

CMAX

Adelaide, South Australia, Australia

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Countries

Australia

References

Evans TG, Bussey L, Eagling-Vose E, Rutkowski K, Ellis C, Argent C, Griffin P, Kim J, Thackwray S, Shakib S, Doughty J, Gillies J, Wu J, Druce J, Pryor M, Gilbert S. Efficacy and safety of a universal influenza A vaccine (MVA-NP+M1) in adults when given after seasonal quadrivalent influenza vaccine immunisation (FLU009): a phase 2b, randomised, double-blind trial. Lancet Infect Dis. 2022 Jun;22(6):857-866. doi: 10.1016/S1473-3099(21)00702-7. Epub 2022 Mar 16.

Reference Type: DERIVED

PMID: 35305317 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FLU009

Identifier Type: -

Identifier Source: org_study_id