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Phase 1

• Conditions: Prophylactic H3N2(A/Brisbane/10/2007) monovalent influenza vaccine, Bris10 M2SR, for protection against influenza disease caused by seasonal influenza A viruses.; MedDRA version: 20.0 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-004971-30-BE
• Lead Sponsor: FluGen, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-28
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Give written informed consent to participate.
2. Age 18 – 55 years old, inclusive.
3. Judged suitable by the Principal Investigator, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
4. Negative test for pregnancy at screening visit, on Day-28 and at Day -2.
5. Negative test for alcohol (breath) and drugs of abuse (urine).
6. Negative test for influenza prior to vaccination.
7. Female subjects should fulfill one of the following criteria:
a. Post-menopausal status defined as no menses for 12 months without an alternative medical cause and/or high follicle-stimulating hormone (FSH) level (>30 mIU/mL) prior to screening.
b. Surgically sterile.
c. Willing to use oral, implantable, transdermal or injectable contraceptives, as outlined in inclusion criteria 8, from screening and until 28 days after challenge infection.
8. Female subjects of childbearing potential must agree to use a reliable form of contraception approved by the Investigator (e.g., oral, implantable, transdermal, or injectable contraception, combined oral, intrauterine device [IUD], or a sterile sexual partner) from screening and until 28 days after challenge infection. Non-surgically sterile male subjects who are sexually active with a female partner(s) of childbearing potential (i.e. males who have not been sterilized by vasectomy for at least 6 months prior to screening) must be willing to use condoms from screening and until 28 days after challenge infection.
9. Willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study.
10. Willing to be confined during the challenge portion of the study.
11. Non-smoker (including prior smokers having stopped smoking for more than 1 year at time of screening) or non-habitual smoker (non-habitual smokers are persons who smoke fewer than 4 cigarettes or other tobacco products on a weekly basis) who agrees to not use tobacco products during the challenge phase of the study.
12. Absent or low levels of detectable pre-existing antibodies to influenza virus H3N2 subtype, strain A/Belgium/4217/2015, as determined by a MN titer of =20 at screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Any subject who is a family member of a) study site personnel, b) personnel involved in conduct or monitoring of study, or c) Sponsor.
2.Has a BMI at screening of less than or equal to 19.0 kg/m2 or greater than or equal to 32.0 kg/m2.
3.Any condition that would limit the subject’s ability to complete the study based on the opinion of the Investigator
4.Abnormal screening hematology or chemistry value per the FDA
5.Pulse rate, blood pressure, or ECG outside the reference range for this study population and considered as clinically significant by the Investigator.
6.Has an acute or chronic medical condition or history of a medical condition
7. Has been vaccinated against influenza within the last 6 months or plans to be inoculated with an influenza vaccine (other than study vaccine) until one month after completion of in-person follow up.
8.Had a flu-like illness, influenza treatment, or prophylactic influenza viral drug administered in the previous 6 months before screening.
9Positive screening test or known infection with HIV, HBV and HCV.
10.History of cancer within 5 years prior to screening
11.Presence or history of lung disease, asthma, chronic obstructive pulmonary disease, or otherwise poor lung function. Childhood asthma that resolved by age 12 years is not criteria for exclusion.
12.Having a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <0.70 and FEV1 <80 % at screening. The interpretation of the spirometry result is at the investigator’s discretion. At the discretion of the investigator or designee, subjects with up to 10% deviation from these values may be included.
13.Any significant abnormality altering the anatomy of the nose or nasopharynx. A test swabbing by mock swab may be performed at screening at the Investigator’s discretion.
14.Any confirmed or suspected immunosuppressive or immunodeficient state including: asplenia, recurrent severe infections and chronic immunosuppressant medication within the last 6 months.
15.Use of immunosuppressive medications, such as allergy shots, immune globulin, interferon, immunomodulators, in the past 6 months or planned to be used during the course of the trial.
16.Use of intranasal corticosteroids within the last 7 days before screening.
17.Significant adulthood history of seasonal hay fever, a seasonal allergic rhinitis, perennial allergic rhinitis, chronic nasal or sinus condition such as sinusitis, at the discretion of the investigator.
18.Received any licensed vaccine within 1 month before screening or planned receipt during the 30 days post challenge.
19. Received or planned administration of another investigational vaccine or drug during the period from 90 days prior to Day 1 to 1 month after completion of in-person follow up.
20.History of allergy/hypersensitivity to any vaccine or virus challenge component challenge agent component or material in nasal delivery device
21.Experienced a life-threatening reaction(s) after a previous administration of any vaccine, or experienced an allergic reaction after a previous administration of any influenza vaccine or component.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified