Clinical trial NCT02436928: A Study to Evaluate the Safety and Immunogenicity of H7N9 Influenza Vaccine (AT-501) in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: H7N9 Influenza Vaccine
Keywords: H7N9 Influenza
Avian influenza A
cell culture derived
Lead sponsor: Medigen Vaccine Biologics Corp.
Sponsor class: INDUSTRY
First posted: 2015-05-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the safety and immunogenicity of an inactivated cell culture derived H7N9 vaccine in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Subject within the age limit range, is free of obvious health problems as judged by the investigator before entering the study.
2. Female subjects must be:

   * either of non-childbearing potential, or one year post-menopausal;
   * or, if of childbearing potential, must be abstinent or have used adequate contraceptive precautions for 30 days prior to receiving the study vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
3. Subject is willing and able to comply with all required study visits and follow-up required by this protocol.
4. Subject must provide written informed consent or the Subjects' legal representative must understand and consent to the procedure.

Exclusion Criteria:

1. Subjects with previous known or potential exposure to avian influenza virus H7N9 HA antigen and any other avian influenza including H5N1.
2. Subjects who have had seasonal influenza vaccine within 6 months prior to enrolment or who will have seasonal influenza vaccine at any time during the study period
3. Subjects administered with any other vaccine during the period within 6 weeks before the first administration of study vaccine.
4. Subjects with confirmed or suspected abnormal immune function, immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
5. Subjects with a history of hypersensitivity to vaccines or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
6. Subjects with a history of inflammatory or degenerative neurological disease .
7. Subjects receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. Inhaled and topical steroids are allowed.
8. Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity.
9. Subjects, judged by the investigator, with any clinically significant medical illness including acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history, physical examination and/or laboratory screening tests.
10. The subjects would not be suitable for the vaccination if the screening laboratory tests show any of the follows

    * ALT or AST \> upper limit of normal range (ULN);
    * Serum creatinine \> upper limit of normal range (ULN);
    * Any significant laboratory abnormality as judged by the investigator
11. Subjects receiving administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or at any time during the study.
12. Subjects with acute disease at the time of enrolment.
13. Use of any investigational or non-registered product other than the study vaccine within 30 days prior to the first vaccination, or planned use of the abovementioned product during the entire study period.
14. Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance.
15. Any clinically relevant disease and/or abnormal laboratory findings (, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
16. Breast feeding or pregnant women or refusal to submit to a urine test to rule out pregnancy prior to enrolment and during the study.

Primary outcomes:
measure: Safety of AT-501 vaccine measured by Adverse Event
timeFrame: 1 year from the start of study enrolment
measure: Immunogenicity of AT-501 vaccine measured by HI titers
timeFrame: 1 year from the start of study enrolment
Secondary outcomes:
measure: Immunogenicity of AT-501 vaccine measured HI and neutralizing antibody titers
timeFrame: 1 year from the start of study enrolment
measure: Safety of AT-501 vaccine measured by Adverse Event
timeFrame: 1 year from the start of study enrolment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shan-Chwen Chang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu UI, Hsieh SM, Lee WS, Wang NC, Kung HC, Ou TY, Chen FL, Lin TY, Chen YC, Chang SC. Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults: A phase I/II, prospective, randomized, open-label trial. Vaccine. 2017 Jul 24;35(33):4099-4104. doi: 10.1016/j.vaccine.2017.06.044. Epub 2017 Jun 28.