Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03880474
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Clinical Network Services (CNS) Pty Ltd
Information provided by (Responsible Party):
Vaccitech Limited

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

Condition or disease Intervention/treatment Phase
Influenza Biological: MVA-NP+M1 Drug: Saline Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: MVA-NP+M1
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.)
Biological: MVA-NP+M1
Trial Vaccine

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




Primary Outcome Measures :
  1. Incidence rate laboratory confirmed influenza [ Time Frame: 210 days ]
    Using reverse transcription polymerase chain reaction (RT-PCR) on deep nasal swap samples to record confirmed cases of influenza.


Secondary Outcome Measures :
  1. Severity of influenza-like illness (ILI) during influenza season [ Time Frame: 210 days ]
    Participant completion of electronic Diaries over the Influenza Season to record symptom severity

  2. Incidence of influenza-like illness (ILI) during influenza season [ Time Frame: 210 days ]
    Participant completion of electronic Diaries over the Influenza Season to record all incidences of ILI

  3. Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination and occurrence of Serious Adverse Events (SAEs) [ Time Frame: 210 days ]
    Completion of electronic Diaries post vaccination to record listed local and systemic reactogenicity and ongoing recording of SAEs throughout the study

  4. To look at the immunogenicity of study drug [ Time Frame: 210 days ]
    By measuring the frequency of influenza-specific T-cells by IFN-γ/granzyme B ELISpot and the Geometric mean titre of influenza-specific neutralising antibodies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880474


Contacts
Layout table for location contacts
Contact: General Enquiries 01865818808 enquiries@vaccitech.co.uk
Contact: Thomas Evans, MD 01865819220 tom.evans@vaccitech.co.uk

Locations
Layout table for location information
Australia, New South Wales
Paratus Clinical Pty Ltd Recruiting
Blacktown, New South Wales, Australia, 2148
Contact: Ushma Narsai, MD         
Genesis Research Services Recruiting
Broadmeadow, New South Wales, Australia, 2292
Contact: Marc Russo, MD         
Paratus Clinical Pty Ltd Recruiting
Kanwal, New South Wales, Australia, 2259
Contact: James Vandeleur, MD       james.vandeleur@paratusclinical.com   
Principal Investigator: James Vandeleur         
Scientia Clinical Research Recruiting
Sydney, New South Wales, Australia, 2031
Contact: James Kuo, MD         
Australia, Queensland
University of Sunshine Coast (USC) Recruiting
Morayfield, Queensland, Australia, 4506
Contact: Nova Evans, MD         
University of Sunshine Coast (USC) Recruiting
Sippy Downs, Queensland, Australia, 4556
Contact: Susan Lynn Thackwray, MD         
Mater Research Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Paul Griffin, MD         
Australia, South Australia
CMAX Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Sepher Shakib, MD         
Australia, Victoria
Nucleus Network Pty Ltd Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Niquita Tugiono, MD         
Sponsors and Collaborators
Vaccitech Limited
Clinical Network Services (CNS) Pty Ltd
Investigators
Layout table for investigator information
Principal Investigator: James Vandeleur, MD Paratus Clinical Pty Ltd

Layout table for additonal information
Responsible Party: Vaccitech Limited
ClinicalTrials.gov Identifier: NCT03880474     History of Changes
Other Study ID Numbers: FLU009
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs