Clinical trial NCT03880474: Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
Official title: A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Barinthus Biotherapeutics
Sponsor class: INDUSTRY
Collaborators: name: Clinical Network Services (CNS) Pty Ltd
First posted: 2019-03-19
Enrollment: 2364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
timeFrame: 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) in line with official Australian influenza season.
Secondary outcomes:
measure: Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
timeFrame: 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
measure: Number and Percentage of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms for 7 Days Following Vaccination (and Occurrence of Serious Adverse Events SAEs)
timeFrame: 7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October)
measure: Number of Participants With Immunogenic Response (Immunogenicity of MVA-NP+M1 in Adjunction With Licensed QIV as Assessed Via Titres of Influenza-specific Neutralizing Antibodies)
timeFrame: Day 28 and Week 26
measure: Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
timeFrame: 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
measure: Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC
timeFrame: 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
measure: Number of Participants With Immunogenic Response to MVA-NP+M1 (as Assessed Via the Frequency of Influenza-specific T-cells)
timeFrame: Day 28 and Week 26
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Paratus Clinical Pty Ltd
state: New South Wales
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Pty Ltd
state: New South Wales
city: Sydney
country: Australia
facility: Scientia Clinical Research
state: New South Wales
city: Morayfield
country: Australia
facility: University of Sunshine Coast (USC)
state: Queensland
city: Sippy Downs
country: Australia
facility: University of Sunshine Coast (USC)
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Research
state: Queensland
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
state: Victoria
Study officials:
affiliation: Paratus Clinical Pty Ltd
name: James Vandeleur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.