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

NCT03880474 | Terminated Phase 2 Results DMC

• 1 other identifier: FLU009
• Study Type: interventional
• Target: 2,364
• Locations: 1 country
• Sites: 9

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR).

  The measure used reverse transcription polymerase chain reaction (RT-PCR) on deep nasal/mid-turbinate swab samples to record confirmed cases of influenza. If influenza symptoms are experienced at any time during the Follow Up period, after the vaccination, participants will attend the clinic on two occasions, the first as soon as possible and at least within 72 hours of the onset of symptoms for deep nasal swabs to be taken. Both swabs must be taken within 96 hours of symptom onset. The incidence rate of laboratory confirmed influenza using RT-PCR will be estimated for each vaccine group. The 95% CI for the incidence rate will be estimated by mid-p exact method. The difference in incidence rate between vaccine groups will be compared by Fisher's exact method.

  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 (6)

• Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary

  210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)

• 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)

  7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October)

• 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)

  Day 28 and Week 26

• Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary

  210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)

• Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC

  210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)

Study Arms (2)

MVA-NP+M1

EXPERIMENTAL

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

Biological: MVA-NP+M1

Saline Placebo

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

MVA-NP+M1 BIOLOGICAL

Trial Vaccine

MVA-NP+M1

Saline DRUG

Sodium Chloride Placebo

Also known as: Placebo

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barinthus Biotherapeutics: lead
• Clinical Network Services (CNS) Pty Ltd: collaborator

Study Sites (9)

Paratus Clinical Pty Ltd

Blacktown, New South Wales, 2148, Australia

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Paratus Clinical Pty Ltd

Kanwal, New South Wales, 2259, Australia

Location

Scientia Clinical Research

Sydney, New South Wales, 2031, Australia

Location

University of Sunshine Coast (USC)

Morayfield, Queensland, 4506, Australia

Location

University of Sunshine Coast (USC)

Sippy Downs, Queensland, 4556, Australia

Location

Mater Research

South Brisbane, Queensland, 4101, Australia

Location

CMAX

Adelaide, South Australia, 5000, Australia

Location

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 35305317 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Tom Evans, MD
• Organization: Vaccitech Ltd.

enquiries@vaccitech.co.uk

+44 01865 591 445

Study Officials

• James Vandeleur, MD

  Paratus Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 19, 2019
• Study Start: March 18, 2019
• Primary Completion: October 15, 2019
• Study Completion: January 21, 2020
• Last Updated: April 26, 2021
• Results First Posted: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9)