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

Phase 1CompletedNCT01928472

Novartis Vaccines402 enrolled

Overview

Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

402

Conditions

H7N9 Influenza

Interventions

H7N9c low dose with adjuvantBIOLOGICAL

H7N9c medium dose with adjuvantBIOLOGICAL

H7N9c high dose with adjuvantBIOLOGICAL

H7N9c high dose without adjuvant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Site 04: Accelovance

San Diego, California, United States

Site 01: Accelovance

Melbourne, Florida, United States

Site 02: Accelovance

Peoria, Illinois, United States

Site 03: Accelovance

Rockville, Maryland, United States

Outcomes

Primary Outcomes

Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 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

Time frame: Day 1 and 43

Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (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.

Time frame: Day 43

Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (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.

Time frame: Day 43

Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)

Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.

Time frame: Day 1 and 43

Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

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.

Time frame: Day 1 to Day 43

Data from ClinicalTrials.gov

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Secondary Outcomes

Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 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.

Time frame: Day 1 and 22

Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)

GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.

Time frame: Day 22

Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (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.

Time frame: Day 22

Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)

Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.

Time frame: Day 1 and 22.

Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)

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.

Time frame: Day 183 and 366.

Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)

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.

Time frame: Day 183 and 366

Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)

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.

Time frame: Day 183 and 366

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)

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.

Time frame: Day 183 and 366