influenza disease MedDRA version: 20.0 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: MVA-NP+M1
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: na
CAS Number: na
Current Sponsor code: MVA-NP+M1
Concentration unit: PFU plaque forming unit
Concentration t
Sponsors
Vaccitech Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females aged =18 and =55 years of age at the point of enrolment. 2. Non-smokers or those who stopped smoking = 3 months prior to screening 1 visit. 3. Willingness to remain in isolation for the duration of the study. 4. A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following: a. 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). b. Of childbearing potential but agrees to practice effective contraception or abstinence from 4 weeks prior to vaccination to 8 weeks after administration of the influenza challenge virus. Acceptable methods of contraception include 1 or more of the following: i. male partner who is sterile prior to the female participants 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) 32. 2. Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness including a history of chronic respiratory illness. 3. History of seasonal hay fever or a seasonal allergic rhinitis (SAR), including the use of symptomatic prescription only medication and non-prescription medication. 4. History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic dermatitis/eczema and atopic rhinitis. 5. Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine. 6. History of lung disease (Asthma, COPD). 7. Current smokers or those who stopped smoking 38.0°C on admission to quarantine. 19. Known close contact with anyone known to have influenza in the past 7 days at the time of quarantine. 20. Known allergy to treatments for influenza (including but not limited to oseltamivir). 21. History of frequent epistaxis (nose bleeds). 22. Any nasal or sinus surgery within 6 months of Viral Challenge or any significant abnormality, either of which results in alteration of the anatomy of the nose or nasopharynx (including significant nasal polyps). 23. Volunteers with household contacts who are at risk for serious or severe complications of influenza disease including, but not limited to, persons > 65 years, presence of significant chronic cardiopulmonary, metabolic, renal, or neurological conditions, immunosuppression due to any condition or therapies, or BMI >40. 24. Subjects that are an employee or family member of the Investigator or study site personnel may not be enrolled. 25. Any other finding that, in the opinion of the Investigator, deems the subject unsuitable for the study Exclusion (Challenge Period only) 1. Abnormal spirometry assessed to be clinically significant. 2. Known close contact wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show that MVA-NP+M1 decreases the viral shedding of influenza virus, as measured by the cumulative area under the curve, following human challenge.;Secondary Objective: Secondary objectives are to show safety, the effect on the incidence of laboratory-confirmed influenza-like illness (ILI), total and individual symptom scores, and mucous production (measured by tissue weight). Immune T cell responses and correlation of these responses with efficacy will also be investigated.;Primary end point(s): Efficacy: Total viral area under the curve (vAUC) for virologic shedding as measured by quantitative PCR (qPCR) for MVA-NP+M1 vs. Placebo groups.;Timepoint(s) of evaluation of this end point: throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence in each group (MVA-NP+M1 and saline Placebo) of laboratory-confirmed ILI (qPCR or culture). - Total AUC for total symptom score (regardless of take rate) for MVA vs. Placebo - Total days of fever for MVA-NP+M1 vs. Placebo - Total mucus weight (regardless of take rate) for MVA vs. Placebo - Correlation of T cell responses (as defined by ELISpot assay) to the primary endpoint, symptom scores, and influenza incidence - The attack rate, defined as percentage of inoculated subjects with at least two consecutive positive swabs as determined by qPCR Safety - Frequency and severity of patient-recorded local and systemic adverse events recorded for the 7 days following vaccination - Frequency and severity of non-solicited adverse events captured throughout the study after vaccination - Frequency and types of serious adverse events - Severity of adverse events in each study group following intranasal challenge with H3N2;Timepoint(s) of evaluation of this end point: throughout the trial | — |
Countries
Belgium
Contacts
Public ContactDalila Karbiche
Vaccitech Ltd
Outcome results
None listed