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InfluenzaPhase 2INVICTUSNCT03300362

Improved Novel VaccIne CombinaTion InflUenza Study

A Phase 2 study testing Seasonal influenza vaccine, MVA-NP+M1 and Sodium chloride in people with Influenza, run by Barinthus Biotherapeutics at 5 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Seasonal influenza vaccine, MVA-NP+M1 and Sodium chloride
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
862 participants
Where
5 sitesUnited Kingdom
Study dates
13 Oct 2017to 31 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Bicester Health Centre

    Bicester, Oxfordshire, OX26 6AT

  • Centre for Clinical Vaccinology and Tropical Medicine (CCVTM

    Oxford, Oxfordshire, OX3 7LJ

  • The Boathouse Surgery

    Pangbourne, Berkshire, RG8 7DF

  • Windrush Health Centre

    Witney, Oxfordshire, OX28 6JS

  • Wokingham Medical Centre

    Wokingham, Berkshire, RG40 1XS

Other trials in United Kingdom

About this study

Official title: A Phase IIb Study to Determine the Safety and Efficacy of Candidate INfluenza Vaccine MVA-NP+M1 in Combination With Licensed InaCTivated inflUenza Vaccine in adultS Aged 65 Years and Above

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.

Read the detailed description

The efficacy of current seasonal influenza vaccines is limited in the face of antigenic mismatch between circulating viral strains and those in the given vaccine. Additionally vaccination in older adults, a major target group for vaccination, prevents laboratory-confirmed influenza in only 30-40% compared to 70-90% in young adults. The hypothesis in this Phase IIb efficacy study is that a new vaccine MVA-NP+M1 with licensed inactivated influenza vaccine (IIV) in the older age group will be able to induce immune responses that protect individuals against influenza illness, severity of symptoms and reduce viral shedding, thereby increasing the protection conferred by seasonal influenza vaccine alone. A total of 2030 participants who are 65 years of age or over and eligible for annual seasonal influenza vaccination and provide informed consent will be recruited to the study. Potential volunteers will be mailed an invitation to take part by their GPs or recruited by local advertisements. Participants will be randomised to receive either MVA- NP+M1 with licensed IIV or saline placebo with licensed IIV. In the first 28 days after vaccination, participants will record adverse events using an electronic or paper diary. The participants will be contacted by telephone 1 day and 7 days post-vaccination to enquire about any serious adverse events and support follow up. During influenza season participants will record weekly whether or not they have had an influenza like illness (ILI). For every ILI episode experienced, the participants will record the severity of their symptoms daily. Among the participants, a total of 100 volunteers (50 in each group) will be recruited into an immunology sub-cohort. They will have blood samples collected on the day of vaccination, 1 week, 3 weeks and 26 weeks post-vaccination for monitoring of laboratory adverse events and immunogenicity purposes.

Conditions
Influenza
Being tested
Seasonal influenza vaccine, MVA-NP+M1, Sodium chloride
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seasonal influenza vaccineDrug

    Also called Quadrivalent Influenza Vaccine

    Seasonal influenza vaccine

  • MVA-NP+M1Drug

    Trial vaccine

  • Sodium chlorideDrug

    Saline placebo

Study groups in NCT03300362
Study groupRoleWhat they receive
Seasonal influenza & MVA-NP+M1ExperimentalTwo vaccinations will be administered: Seasonal influenza vaccine \& MVA-NP+M1
Receives: Drug: Seasonal influenza vaccine; Drug: MVA-NP+M1
Seasonal influenza & saline placeboPlacebo comparatorTwo vaccinations will be administered: Seasonal influenza vaccine \& sodium chloride
Receives: Drug: Seasonal influenza vaccine; Drug: Sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days with moderate or severe influenza-like symptoms

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

    Measured: 6-7 months

Secondary outcomes (11)

  1. Incidence of influenza-like-illness

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

    Measured: 6-7 months

  2. Severity of influenza-like symptoms

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

    Measured: 6-7 months

  3. Duration of influenza-like-illnes

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

    Measured: 6-7 months

  4. Occurrence of GP consultations from respiratory illness

    Throughout the influenza season - self-reported and Medical Records

    Measured: 6-7 months

  5. Occurrence of hospitalisations and deaths due to respiratory illness

    Throughout the influenza season - self-reported and Medical Records

    Measured: 6-7 months

  6. Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination

    Self-reported symptoms recorded using electronic or paper diaries

    Measured: Day 0-7

  7. Occurrence of serious adverse events during the whole study duration

    Telephone calls on Day 1-3, day 7-9 and every 3-4 weeks throughout volunteers' participation in the trial

    Measured: 6-7 months

  8. Occurrence of unsolicited adverse events for 28 days following vaccination

    Self-reported symptoms recorded using electronic or paper diaries

    Measured: Day 0-28

  9. Frequency of influenza-specific T-cells measured by IFNg ELISpot

    To assess the immunogenicity of MVA-NP+M1 in combination with the recommended licensed inactivated influenza vaccine in adults aged 65 years and above

    Measured: 6-7 months

  10. Geometric mean titre of influenza-specific neutralising antibodies

    To assess the immunogenicity of MVA-NP+M1 in combination with the recommended licensed inactivated influenza vaccine in adults aged 65 years and above

    Measured: 6-7 months

  11. Breadth of influenza-specific T-cells and antibodies

    To assess the immunogenicity of MVA-NP+M1 in combination with the recommended licensed inactivated influenza vaccine in adults aged 65 years and above

    Measured: 6-7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2017
  2. Study start13 Oct 2017
  3. Primary completion31 Oct 2018
  4. Study completion31 Oct 2018

Why it stopped: Change to recommended season flu vaccine in UK

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
862 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03300362
Sponsor's protocol ID
FLU007 INVICTUS
Acronym
INVICTUS
Status last verified
May 2018
First submitted
26 Sep 2017
Last updated
23 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32089822

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Seasonal influenza vaccine, MVA-NP+M1 and Sodium chloride in people with Influenza, run by Barinthus Biotherapeutics at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change to recommended season flu vaccine in UK). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days with moderate or severe influenza-like symptoms (time frame: 6-7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03300362, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.

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