The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03880474




Registration number
NCT03880474
Ethics application status
Date submitted
21/02/2019
Date registered
19/03/2019
Date last updated
17/07/2019

Titles & IDs
Public title
Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
Scientific title
A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over
Secondary ID [1] 0 0
FLU009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MVA-NP+M1
Treatment: Drugs - Saline

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

Placebo Comparator: Saline Placebo - Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%)


Other interventions: MVA-NP+M1
Trial Vaccine

Treatment: Drugs: Saline
Sodium Chloride Placebo

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate laboratory confirmed influenza - Using reverse transcription polymerase chain reaction (RT-PCR) on deep nasal swap samples to record confirmed cases of influenza.
Timepoint [1] 0 0
210 days
Secondary outcome [1] 0 0
Severity of influenza-like illness (ILI) during influenza season - Participant completion of electronic Diaries over the Influenza Season to record symptom severity
Timepoint [1] 0 0
210 days
Secondary outcome [2] 0 0
Incidence of influenza-like illness (ILI) during influenza season - Participant completion of electronic Diaries over the Influenza Season to record all incidences of ILI
Timepoint [2] 0 0
210 days
Secondary outcome [3] 0 0
Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination and occurrence of Serious Adverse Events (SAEs) - Completion of electronic Diaries post vaccination to record listed local and systemic reactogenicity and ongoing recording of SAEs throughout the study
Timepoint [3] 0 0
210 days
Secondary outcome [4] 0 0
To look at the immunogenicity of study drug - By measuring the frequency of influenza-specific T-cells by IFN-?/granzyme B ELISpot and the Geometric mean titre of influenza-specific neutralising antibodies
Timepoint [4] 0 0
210 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd - Blacktown
Recruitment hospital [2] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [3] 0 0
Paratus Clinical Pty Ltd - Kanwal
Recruitment hospital [4] 0 0
Scientia Clinical Research - Sydney
Recruitment hospital [5] 0 0
University of Sunshine Coast (USC) - Morayfield
Recruitment hospital [6] 0 0
University of Sunshine Coast (USC) - Sippy Downs
Recruitment hospital [7] 0 0
Mater Research - South Brisbane
Recruitment hospital [8] 0 0
CMAX - Adelaide
Recruitment hospital [9] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2031 - Sydney
Recruitment postcode(s) [5] 0 0
4506 - Morayfield
Recruitment postcode(s) [6] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaccitech Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Clinical Network Services (CNS) Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT03880474
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Vandeleur, MD
Address 0 0
Paratus Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications