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Comparison of the Cellular and the Humoral Immunogenicity, Safety of Different Trivalent Influenza Vaccines (FLUSECUOEKH1)

Primary Purpose

Healthy Volunteers

Status

Unknown status

Phase

Phase 4

Locations

Hungary

Study Type

Interventional

Intervention

influenza vaccine

About this trial

This is an interventional prevention trial for Healthy Volunteers focused on measuring influenza vaccine, cellular immune response, humoral immune response

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adult volunteers > 18 and < 60 years of age, both sexes;
Full contractual capacity of the participants
Are in good health (as determined by vital signs and medical history);
Negative urine or serum pregnancy test for females of childbearing potential.
If the subject is female and of childbearing potential, she must use an acceptable contraception method and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner);
Are able to understand and comply with planned study procedures;
Signed informed consent prior to initiation of study procedures;
Absence of existence of any exclusion criteria

Exclusion Criteria:

Known allergy to eggs OR other components of any of the vaccines (in particular mercury);
History of Guillain-Barré syndrome;
Pregnancy OR breast feeding OR positive pregnancy test prior to vaccination;
Immunosuppressive therapy in the preceding 36 months;
Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
Concomitant corticosteroid therapy, including inhaled corticosteroids. Local corticosteroid or corticosteroid nasal spray are permitted.
Psychiatric illness and/or concomitant psychiatric drug therapy that may have effect on full contractual capacity of the participant;
Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
Vaccine therapy within 4 weeks prior to the study;
Influenza vaccination within 2 years prior to the study;
Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
Documented HIV, HBV or HCV infection;
Acute febrile respiratory illness within one week prior to vaccination;
Experimental drug therapy within 1 month prior to vaccination;
Alcohol or drug abuse

Sites / Locations

National Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

humoral and cellular immune response

reactogenicity

Arm Description

Outcomes

Primary Outcome Measures

Number of seroconversions, > 4-fold increase in Haemagglutination inhibition (HI), mean geometric increase and antibody titre the proportion of subjects achieving an HI titre > 40, virus neutralization assay, Granzyme B, INF-gamma, IL-10, side effects.

There remains substantial uncertainty about the clinical effectiveness of influenza vaccines based on current health care literature. The standard methodology to determine vaccine efficacy is based on hemagglutinin inhibition assay. Assays based on the immune response against the N antigen and based on the cellular immune response are now being designed and validated in the EU-funded Flusecure project. Importantly, recent EMEA regulations for registration of vaccines against avian influenza require an assessment of the cellular and the N-specific immune responses (EMEA/CHMP/VWP/263499/2006).

Secondary Outcome Measures

Side effects

In the course of tolerability assessment the frequency, mean time of appearance, duration and severity of the AEs (local and general) will be assessed according to CPMP/BWP/214/968: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997, Para. 2.4., 2.6., and 3.2.

Full Information

NCT ID

NCT01119157

First Posted

May 4, 2010

Last Updated

May 6, 2010

Sponsor

National Centre for Epidemiology, Hungary

Collaborators

Netherlands Vaccine Institute, National Public Health Institute, Finland

1. Study Identification

Unique Protocol Identification Number

NCT01119157

Brief Title

Comparison of the Cellular and the Humoral Immunogenicity, Safety of Different Trivalent Influenza Vaccines

Acronym

FLUSECUOEKH1

Official Title

Comparison of the Cellular and the Humoral Immunogenicity as Well as the Safety of Different Trivalent Influenza Vaccines in Healthy Adults Between 18 and 60 Years of Age

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Centre for Epidemiology, Hungary

Collaborators

Netherlands Vaccine Institute, National Public Health Institute, Finland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18 and < 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.

Detailed Description

This is a randomized, single-blinded study on vaccines for prevention of influenza. Three study visits will be scheduled for each study subject, at Day 0, Day 9-11 and Day 30-35. Prior to the performance of any protocol procedures, the investigator is will obtain an informed consent from each participant. At the first study visit (Day 0), demographic data, medical history, pre-existing conditions and concomitant medication will be recorded. Physical examination with recording of vital signs will be performed and in case of females of childbearing age, a pregnancy test will be performed. After the subject has qualified eligible, before vaccination, 60 ml venous blood will be taken for base-line immunity tests. Each subject will be randomly allocated to receive one of the three study vaccines, administered as a deep intramuscular (i.m.) injection into the deltoid muscle. The subjects will be blinded for the vaccine regimen. The principal investigator will administer the vaccines filled in ampoule or packed in pre-filled ready-to-use syringes and can thus not be blinded, but the staff and sub-investigators responsible for the routine follow-up and assessments and laboratory personnel will be blinded. A diary card will be given to each subject for recording pre-defined solicited adverse events for the vaccination day and 6 subsequent days and all other adverse events and concomitant medications. At the second study visit (Day 9-11) the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests. A new diary card will be given to each subject for recording adverse events and concomitant medications. At the third study visit (Day 30-35), the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers

Keywords

influenza vaccine, cellular immune response, humoral immune response

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

humoral and cellular immune response

Arm Type

Experimental

Arm Title

reactogenicity

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

influenza vaccine

Other Intervention Name(s)

FluvalAB adjuvanted trivalent seasonal influenza vaccine, Vaxigrip, Influvac

Intervention Description

whole virus influenza vaccine adjuvanted with aluminium phosphate, 3 x 15 μg HA / 0.5 ml, for i.m. administration subunit influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration split influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration

Primary Outcome Measure Information:

Title

Description

Time Frame

Day 35

Secondary Outcome Measure Information:

Title

Side effects

Description

Time Frame

65 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adult volunteers > 18 and < 60 years of age, both sexes; Full contractual capacity of the participants Are in good health (as determined by vital signs and medical history); Negative urine or serum pregnancy test for females of childbearing potential. If the subject is female and of childbearing potential, she must use an acceptable contraception method and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner); Are able to understand and comply with planned study procedures; Signed informed consent prior to initiation of study procedures; Absence of existence of any exclusion criteria Exclusion Criteria: Known allergy to eggs OR other components of any of the vaccines (in particular mercury); History of Guillain-Barré syndrome; Pregnancy OR breast feeding OR positive pregnancy test prior to vaccination; Immunosuppressive therapy in the preceding 36 months; Active neoplasm (i.e. requiring any form of anti-neoplastic therapy); Concomitant corticosteroid therapy, including inhaled corticosteroids. Local corticosteroid or corticosteroid nasal spray are permitted. Psychiatric illness and/or concomitant psychiatric drug therapy that may have effect on full contractual capacity of the participant; Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination; Vaccine therapy within 4 weeks prior to the study; Influenza vaccination within 2 years prior to the study; Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response; Documented HIV, HBV or HCV infection; Acute febrile respiratory illness within one week prior to vaccination; Experimental drug therapy within 1 month prior to vaccination; Alcohol or drug abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ildikó Visontai, MD

Organizational Affiliation

National Centre for Epidemiology

Official's Role

Study Director

Facility Information:

Facility Name

National Health Centre

City

Budapest

ZIP/Postal Code

H-1134

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Cellular and the Humoral Immunogenicity, Safety of Different Trivalent Influenza Vaccines

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