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H7N9 Influenza VaccinePhase 1/2NCT02436928

A Study to Evaluate the Safety and Immunogenicity of H7N9 Influenza Vaccine (AT-501) in Healthy Adult Subjects

A Phase 1/2 study testing AT-501 High Dose vaccine, AT-501 High Dose vaccine with Adjuvant and AT-501 Low Dose vaccine in people with H7N9 Influenza Vaccine, run by Medigen Vaccine Biologics Corp. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the safety and immunogenicity of an inactivated cell culture derived H7N9 vaccine in healthy adult subjects. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
H7N9 Influenza Vaccine
What is being tested?
AT-501 High Dose vaccine, AT-501 High Dose vaccine with Adjuvant and AT-501 Low Dose vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTaiwan
Study dates
Apr 2015to Feb 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject within the age limit range, is free of obvious health problems as judged by the investigator before entering the study.
  • 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.
  • Subject is willing and able to comply with all required study visits and follow-up required by this protocol.
  • Subject must provide written informed consent or the Subjects' legal representative must understand and consent to the procedure.

Who cannot join

  • Subjects with previous known or potential exposure to avian influenza virus H7N9 HA antigen and any other avian influenza including H5N1.
  • 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
  • Subjects administered with any other vaccine during the period within 6 weeks before the first administration of study vaccine.
  • 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.
  • 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.
  • Subjects with a history of inflammatory or degenerative neurological disease .
Show all 19Show fewer
  • 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.
  • Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity.
  • 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.
  • 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
  • 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.
  • Subjects with acute disease at the time of enrolment.
  • 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.
  • Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance.
  • 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.
  • Breast feeding or pregnant women or refusal to submit to a urine test to rule out pregnancy prior to enrolment and during the study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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

Being tested
AT-501 High Dose vaccine, AT-501 High Dose vaccine with Adjuvant, AT-501 Low Dose vaccine, AT-501 Low Dose vaccine with Adjuvant
Keywords
H7N9 Influenza, Avian influenza A, cell culture derived

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AT-501 High Dose vaccineBiological

    Comparison of each dose of vaccine

  • AT-501 High Dose vaccine with AdjuvantBiological

    Comparison of each dose of vaccine

  • AT-501 Low Dose vaccineBiological

    Comparison of each dose of vaccine

  • AT-501 Low Dose vaccine with AdjuvantBiological

    Comparison of each dose of vaccine

Study groups in NCT02436928
Study groupRoleWhat they receive
AT-501 High Dose vaccineExperimentalInactivated H7N9 High Dose Antigen
Receives: Biological: AT-501 High Dose vaccine
AT-501 High Dose vaccine with AdjuvantExperimentalInactivated H7N9 High Dose Antigen with Adjuvant
Receives: Biological: AT-501 High Dose vaccine with Adjuvant
AT-501 Low Dose vaccineExperimentalInactivated H7N9 Low Dose Antigen
Receives: Biological: AT-501 Low Dose vaccine
AT-501 Low Dose vaccine with AdjuvantExperimentalInactivated H7N9 Low Dose Antigen with Adjuvant
Receives: Biological: AT-501 Low Dose vaccine with Adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of AT-501 vaccine measured by Adverse Event

    Phase 1

    • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period after the first and second dose of administered vaccine.
    • Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period after each administered vaccine.
    • Occurrence of overall adverse events and serious adverse events during the entire period of study.

    Measured: 1 year from the start of study enrolment

  2. Immunogenicity of AT-501 vaccine measured by HI titers

    Phase 2

    HI titers as follows:

    • Seroconversion Rate (SCR) at day 22 and 43
    • Seroconversion Factor (SCF) at day 22 and day 43
    • Seroprotection Rate (SPR) at day 22 and day 43

    Measured: 1 year from the start of study enrolment

Secondary outcomes (2)

  1. Immunogenicity of AT-501 vaccine measured HI and neutralizing antibody titers

    Phase 1

    • Change of antibody titers from baseline to day 22 and day 43
    • Geometric Mean Titer (GMT) of both serum HI titers and neutralizing antibody titers, pre-vaccination and day 22 and day 43 post-vaccination

    Measured: 1 year from the start of study enrolment

  2. Safety of AT-501 vaccine measured by Adverse Event

    Phase 2

    • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period after the first and second dose of administered vaccine.
    • Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period after each administered vaccine.
    • Occurrence of overall adverse events and serious adverse events during the entire period of study.

    Measured: 1 year from the start of study enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02436928
Sponsor's protocol ID
CT-MV-21
Status last verified
Mar 2016
First submitted
27 Apr 2015
Last updated
22 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28668573

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AT-501 High Dose vaccine, AT-501 High Dose vaccine with Adjuvant and AT-501 Low Dose vaccine in people with H7N9 Influenza Vaccine, run by Medigen Vaccine Biologics Corp. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of AT-501 vaccine measured by Adverse Event (time frame: 1 year from the start of study enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02436928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.

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