Improved Novel VaccIne CombinaTion InflUenza Study

NCT03300362 | Terminated Phase 2 DMC

• 1 other identifier: FLU007 INVICTUS
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 5

Brief Summary

A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100 participants will be recruited to an immunology sub-cohort.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Number of days with moderate or severe influenza-like symptoms

  Throughout the influenza season, self-reported symptoms recorded using electronic or paper diaries

  6-7 months

Secondary Outcomes (11)

• Incidence of influenza-like-illness

  6-7 months

• Severity of influenza-like symptoms

  6-7 months

• Duration of influenza-like-illnes

  6-7 months

• Occurrence of GP consultations from respiratory illness

  6-7 months

• Occurrence of hospitalisations and deaths due to respiratory illness

  6-7 months

Other Outcomes (1)

• Estimated frequency of influenza infection using historical data on the proportion of ILIs that is caused by influenza virus infection.

  6-7 months

Study Arms (2)

Seasonal influenza & MVA-NP+M1

EXPERIMENTAL

Two vaccinations will be administered: Seasonal influenza vaccine \& MVA-NP+M1

Drug: Seasonal influenza vaccine; Drug: MVA-NP+M1

Seasonal influenza & saline placebo

PLACEBO COMPARATOR

Two vaccinations will be administered: Seasonal influenza vaccine \& sodium chloride

Drug: Seasonal influenza vaccine; Drug: Sodium chloride

Interventions

Seasonal influenza vaccine DRUG

Seasonal influenza vaccine

Also known as: Quadrivalent Influenza Vaccine

Seasonal influenza & MVA-NP+M1; Seasonal influenza & saline placebo

MVA-NP+M1 DRUG

Trial vaccine

Seasonal influenza & MVA-NP+M1

Sodium chloride DRUG

Saline placebo

Seasonal influenza & saline placebo

Eligibility Criteria

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

You may qualify if:

• Volunteer is willing and has capacity to provide written informed consent for participation in the trial (in the Investigator's opinion).
• Male or female adults, aged 65 years and above
• Able and willing (in the Investigator's opinion) to comply with all study requirements
• Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
• Eligible to receive seasonal influenza vaccine

You may not qualify if:

• Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine (e.g. egg allergy)
• Ongoing terminal illness with a life expectancy estimated to be approximately \<6 months.
• Continuous use of oral anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
• Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study
• Participation in another clinical trial of an investigational medicinal product in the 30 days preceding enrolment, or planned use during the study period
• Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data
• Receipt of annual seasonal influenza vaccine prior to enrolment (for the same influenza season volunteers are recruited in)
• Not willing to comply with study procedures

Sponsors & Collaborators

• Barinthus Biotherapeutics: lead
• University of Oxford: collaborator

Study Sites (5)

The Boathouse Surgery

Pangbourne, Berkshire, RG8 7DF, United Kingdom

Location

Wokingham Medical Centre

Wokingham, Berkshire, RG40 1XS, United Kingdom

Location

Bicester Health Centre

Bicester, Oxfordshire, OX26 6AT, United Kingdom

Location

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Windrush Health Centre

Witney, Oxfordshire, OX28 6JS, United Kingdom

Location

Related Publications (1)

• Swayze H, Allen J, Folegatti P, Yu LM, Gilbert S, Hill A, Ellis C, Butler CC. A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol. F1000Res. 2019 May 23;8:719. doi: 10.12688/f1000research.19090.1. eCollection 2019.

  PMID: 32089822 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christopher Butler

  University of Sussex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Investigators recording clinical outcomes will also be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 3, 2017
• Study Start: October 13, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)