Clinical Study to Evaluate Antibody and Cell Mediated Immunity of A/H1N1 Influenza Vaccine in Healthy Subjects

NCT01079273 | Completed Phase 4

• 2 other identifiers: V111_06TP_OPERA2009-017141-58
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is explore the antibody and cell mediated immune responses to one injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.

Conditions

Influenza

Keywords

Influenza; Vaccines; A/H1N1; Influenza Vaccines

Outcome Measures

Primary Outcomes (1)

• Antibody and cell mediated immune responses to one 0.50 mL IM injection of egg-derived Focetria™ pandemic influenza vaccine in terms of quality and quantity of the antigen-specific T- and B-cell response

  Cell Mediated Immunity (CMI) assessed by frequencies and fold increases of antigen-specific CD4+ T-cells and B-lymphocytes on Day 0,8,22,202. Immunogenicity, i.e. Haemagglutination Inhibition (HI), Single Radial Haemolysis (SRH) and Microneutralization (MN), assessed as follows: 1. Geometric mean titer (GMT)/Geometric mean area (GMA) on Day 0,8,22,202. 2. Geometric mean ratio (GMR) at each time-point vs. Day 0. 3. Percentage of subjects achieving seroconversion or significant increase on Day 8,22,202. 4. Percentage of subjects with HI (or MN) titer≥40 and SRH≥25 mm2 on Day 0,8,22,202.

  On day 8, 22, 202 after vaccination

Secondary Outcomes (2)

• Antibody responses to one injection of egg-derived Focetria™ pandemic influenza vaccine according to CHMP criteria

  On day 8, 22, 202 after vaccination

• Safety and tolerability

  Within 30 minutes after vaccination (Day 0) and on day 8, 22 and 202 after vaccination

Study Arms (1)

Vaccine

ACTIVE COMPARATOR

All Subjects enrolled in this study will receive the study vaccine (single-arm)

Biological: egg-derived A/H1N1 pandemic influenza vaccine

Interventions

egg-derived A/H1N1 pandemic influenza vaccine BIOLOGICAL

One 0.50 mL IM dose injection (7.5 µg of vaccine + 9.75 mg MF59)

Also known as: Focetria™

Vaccine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent obtained;
• Males and females from 18 years to 60 years of age on the day of enrolment;
• Subjects in good health as determined by the outcome of medical history, physical assessment and clinical judgment by the Investigator;
• Subjects are able to comply with all study procedures and are available for all clinic visits scheduled in the study;
• Willingness to allow for blood samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

You may not qualify if:

• Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;
• Subjects with history or any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
• Subjects with any serious chronic or progressive disease according to judgment of the Investigator (including, but not limited to malignant neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
• History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins;
• Subjects who have had seasonal influenza vaccine or documented confirmed seasonal influenza disease within 2 weeks prior to Day 1;
• Receipt of another investigational agent within 4 weeks prior to enrolment, or before completion of the safety follow-up period in this or in another study; subjects unwilling to refuse participation in another clinical study throughout the end of this study;
• Subjects who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until 2 weeks before and over 2 weeks after the study vaccination;
• Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks or plan to receive these products during the full length of the study;
• Subjects with axillary temperature ≥ 38°C (≥ 100.4°F) or oral temperature ≥ 38.5°C (≥ 101.3°F) within 3 days of intended study vaccination;
• Known or suspected impairment/alteration of immune function, for example resulting from:
• receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis (10 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800µg/day or fluticasone 750µg/day) within 60 days prior to Visit 1,
• cancer chemotherapy within 5 years,
• receipt of immunostimulants within 60 days prior to Visit 1,
• history of HIV infection or HIV-related disease;
• History of progressive or severe neurological disorders (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions);

Sponsors & Collaborators

• Opera CRO, a TIGERMED Group Company: lead

Study Sites (1)

Azienda Ospedaliera Universtaria Senese

Siena, 53100, Italy

Location

Related Publications (2)

• Faenzi E, Zedda L, Bardelli M, Spensieri F, Borgogni E, Volpini G, Buricchi F, Pasini FL, Capecchi PL, Montanaro F, Belli R, Lattanzi M, Piccirella S, Montomoli E, Ahmed SS, Rappuoli R, Del Giudice G, Finco O, Castellino F, Galli G. One dose of an MF59-adjuvanted pandemic A/H1N1 vaccine recruits pre-existing immune memory and induces the rapid rise of neutralizing antibodies. Vaccine. 2012 Jun 8;30(27):4086-94. doi: 10.1016/j.vaccine.2012.04.020. Epub 2012 Apr 19.

  PMID: 22521851 RESULT

• Ahmed SS, Volkmuth W, Duca J, Corti L, Pallaoro M, Pezzicoli A, Karle A, Rigat F, Rappuoli R, Narasimhan V, Julkunen I, Vuorela A, Vaarala O, Nohynek H, Pasini FL, Montomoli E, Trombetta C, Adams CM, Rothbard J, Steinman L. Antibodies to influenza nucleoprotein cross-react with human hypocretin receptor 2. Sci Transl Med. 2015 Jul 1;7(294):294ra105. doi: 10.1126/scitranslmed.aab2354.

  PMID: 26136476 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

focetria

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Franco Laghi Pasini, MD

  Azienda Ospedaliera Universitaria Senese

  PRINCIPAL INVESTIGATOR

• Laura Michellini

  Opera CRO, a TIGERMED Group Company

  STUDY CHAIR

• Fabio Montanaro, DSc

  Opera CRO, a TIGERMED Group Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: December 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

IT (1)