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Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years

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ClinicalTrials.gov Identifier: NCT01928472
Recruitment Status : Completed
First Posted : August 26, 2013
Results First Posted : May 21, 2015
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Description
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Brief Summary:
Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Condition or disease Intervention/treatment Phase
H7N9 Influenza Biological: H7N9c low dose with adjuvant Biological: H7N9c medium dose with adjuvant Biological: H7N9c high dose with adjuvant Biological: H7N9c high dose without adjuvant Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza Virus Vaccine (H7N9c) in Adults 18 to <65 Years
Study Start Date : August 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
H7N9c low dose with adjuvant
 Biological: H7N9c low dose with adjuvant
Experimental: Group B
H7N9c medium dose with adjuvant
 Biological: H7N9c medium dose with adjuvant
Experimental: Group C
H7N9c high dose with adjuvant
 Biological: H7N9c high dose with adjuvant
Experimental: Group D
H7N9c high dose without adjuvant
 Biological: H7N9c high dose without adjuvant


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) [ Time Frame: Day 1 and 43 ]
    Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination

  2. Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) [ Time Frame: Day 43 ]
    Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.

  3. Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) [ Time Frame: Day 43 ]

    Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.

    Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.


  4. Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) [ Time Frame: Day 1 and 43 ]
    Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.

  5. Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine [ Time Frame: Day 1 to Day 43 ]
    Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.

  6. Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine [ Time Frame: Day 1 to Day 366. ]
    The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.

  7. Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine [ Time Frame: Day 1 through Day 7 after each vaccination. ]
    Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.


Secondary Outcome Measures :
  1. Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) [ Time Frame: Day 1 and 22 ]
    Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.

  2. Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) [ Time Frame: Day 22 ]
    GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.

  3. Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) [ Time Frame: Day 22 ]

    Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.

    Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.


  4. Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) [ Time Frame: Day 1 and 22. ]
    Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.

  5. Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) [ Time Frame: Day 183 and 366. ]
    The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.

  6. Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) [ Time Frame: Day 183 and 366 ]
    GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.

  7. Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) [ Time Frame: Day 183 and 366 ]

    Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.

    Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10.


  8. Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) [ Time Frame: Day 183 and 366 ]
    Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult subject ages 18-64 years.
  2. Individuals willing to provide written informed consent
  3. Individuals in good health.
  4. Individuals who can comply with study procedures and follow-up.

Exclusion Criteria:

  1. Individuals with history of cognitive or behavioral impairment or psychiatric disease,
  2. Individuals unable to understand and follow study procedures,
  3. History of significant illness,
  4. History of chronic medical condition or progressive disease,
  5. Allergy to any vaccine component or adverse event related to a vaccine component,
  6. Impairment/alteration of the immune system,
  7. Presence of progressive or severe neurological disorder,
  8. Pregnant or breast-feeding,
  9. Female of Child-bearing potential unwilling to use acceptable method of birth control,
  10. Presence of medically significant cancer,
  11. Receipt of investigational product within 30 day prior to entry into the study,
  12. History of previous or suspected illness from avian flu caused by H7N9 virus,
  13. History of H7 vaccination,
  14. Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
  15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
  16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
  17. History of drug or alcohol abuse within the past 2 years,
  18. Body Mass Index (BMI) greater than or equal to 35kg/m2,
  19. Individuals conducting the study or their immediate family members.
Contacts and Locations
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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): NCT01928472


Locations
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United States, California
Site 04: Accelovance
San Diego, California, United States, 92108
United States, Florida
Site 01: Accelovance
Melbourne, Florida, United States, 32935
United States, Illinois
Site 02: Accelovance
Peoria, Illinois, United States, 61602
United States, Maryland
Site 03: Accelovance
Rockville, Maryland, United States, 20850
United States, Utah
Site 05: Janet Lewis
Salt Lake City, Utah, United States, 84109
Site 06: Janet Lewis
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
More Information
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01928472    
Other Study ID Numbers: V131_01
First Posted: August 26, 2013    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: June 11, 2019
Last Verified: May 2019
Keywords provided by Novartis ( Novartis Vaccines ):
Influenza, H7N9, Vaccine
Additional relevant MeSH terms:
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Influenza, Human
Influenza in Birds
Respiratory Tract Infections
Infections
 Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases