An Open-Label Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as Well as in Specified Risk Groups

Resilience Government Services, Inc.45 sites in 7 countries3,583 target enrollmentAugust 2008

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Resilience Government Services, Inc.
Enrollment: 3583
Locations: 45
Primary Endpoint: Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by microneutralization (MN) assay >= 1:20.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

October 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Resilience Government Services, Inc.

Eligibility Criteria

Inclusion Criteria

•The following inclusion criteria apply to subjects in all three cohorts:
•Male and female subjects will be eligible for participation in this study if they:
•Are 18 years of age or older on the day of screening;
•Have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry;
•Are physically and mentally capable of participating in the study and follow its procedures;
•Agree to keep a daily record of symptoms for the duration of the study;
•If female of childbearing potential - have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.
•The following inclusion criterion applies to subjects in Cohort 1 only:
•Are generally healthy \[1\], as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination.
•(\[1\]) Subjects with controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in Cohort 1 of this study.

Exclusion Criteria

•The following exclusion criteria apply to subjects in all three cohorts:
•Subjects will be excluded from participation in this study if they:
•Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine;
•Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
•Have a history of severe allergic reactions or anaphylaxis;
•Have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
•Have donated blood or plasma within 30 days prior to study entry;
•Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
•Have a known or suspected problem with alcohol or drug abuse;
•Were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product;

Outcomes

Primary Outcomes

Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by microneutralization (MN) assay >= 1:20.

Time Frame: 42 days

Frequency and severity of systemic reactions until 21 days after the first and second vaccinations

Time Frame: 42 days

Antibody response 21 days after the second vaccination as measured by MN assay;

Time Frame: 42 days

Secondary Outcomes

Number of subjects with antibody response associated with protection 21 days after the first and second vaccinations defined as Hemagglutination Inhibition Antibody (HIA) titer >= 1:40 or Single Radial Hemolysis (SRH) area >= 25 mm2(42 days)
Number of subjects with fever, malaise or shivering with onset within 7 days after the first and second vaccinations(7 days)
Antibody response 21 days after the first and second vaccinations as measured by HI and SRH assays(42 days)
Fold increase of antibody response 21 days after the first and second vaccinations as compared to baseline as measured by MN, HI and SRH assays(42 days)
Fold increase of antibody response in the subset of subjects included in the assessment of antibody kinetics 28, 35 and 90 days after the first vaccination as compared to baseline as measured by MN, HI and SRH assays(90 days)
Number of subjects in subset for antibody kinetics evaluation with seroconversion (see definitions above) 28, 35, 90 days after 1st vaccination, measured by MN, HI, SRH(90 days)
T-cell response in the subset of subjects included in the evaluation of cellular immunity after each vaccination as determined by the frequency of cytokine producing T-cells induced by influenza virus antigens(201 days)
Number of subjects with antibody response associated with protection 21 days after the second vaccination defined as titer measured by MN assay >=1:40, >= 1:80, >=1:160(42 days)
Number of subjects in the subset included in the assessment of antibody kinetics with antibody response associated with protection 28, 35 and 90 days after the first vaccination as measured by MN, HI and SRH assays(90 days)
Frequency and severity of injection site reactions until 21 days after the first and second vaccinations(42 days)
Frequency and severity of adverse events observed during the entire study period(11 months)
Antibody response 201 days after the first vaccination as measured by MN, HI and SRH assays(201 days)
Antibody response in the subset of subjects included in the assessment of antibody kinetics 28, 35 and 90 days after the first vaccination as measured by MN, HI and SRH assays(90 days)
Increase in frequency of cytokine producing T-cells induced by influenza virus antigens after each vaccination as compared to baseline(201 days)
Antibody response 21 days after the first vaccination as measured by MN assay(21 days)
Number of subjects with seroconversion (MN/HI: min.4-fold titer increase vs baseline;SRH:post-vacc. hemolysis area >=25mm2 or increased by >=50% for pre-vacc. sample <=4mm2 and >4mm2, resp., 21 days after 1st and 2nd vaccinations, measured by MN,HI,SRH(42 days)
Number of subjects with antibody response associated with protection 201 days after the first vaccination as measured by MN, HI and SRH assays(201 days)
Fold increase of antibody response 201 days after the first vaccination as compared to baseline as measured by MN, HI and SRH assays(201 days)
Number of subjects with antibody response associated with protection 21 days after the first vaccination defined as titer measured by MN assay >=1:20, >=1:40, >=1:80, >=1:160(21 days)