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InfluenzaPhase 4NCT01079273

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

A Phase 4 study testing egg-derived A/H1N1 pandemic influenza vaccine in people with Influenza, run by Opera CRO, a TIGERMED Group Company at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
egg-derived A/H1N1 pandemic influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteItaly
Study dates
Dec 2009to Nov 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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);
  • History of or clinically suspected developmental delay;
  • Bleeding diathesis;
  • Surgery planned during the study period that in the Investigator's opinion would interfere with the study;
  • Female subjects who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used any of the "acceptable contraceptive methods" for the 2 months before entering the study or do not plan to use them up to the end of the study;
  • Members of the research staff who have direct access to any study documents containing subject information.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera Universtaria Senese

    Siena, 53100

Other trials in Italy

About this study

Official title: An Open-Label Exploratory Clinical Study to Evaluate the Antibody and Cell Mediated Immunity of One Intramuscular Dose of MF59-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 to 60 Years

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.

Read the detailed description

This will be a Phase IV open-label clinical profiling study. The population to be enrolled will consist of healthy adults aged 18-60 years. A total of approximately 60 subjects are planned for enrolment into this study.

Subjects enrolled in this study will receive 7.5 µg of vaccine + MF59 (9.75 mg/dose). Each subject will receive one 0.5 mL IM dose (deltoid muscle, non-dominant arm) of H1N1sw vaccine at Visit 1, after the blood draw. Up to 70 mL of blood will be drawn for CMI and antibody assessment from all subjects at all study visits.

Subjects will be requested to declare occurrence of influenza-related symptoms during the study period. Whenever appropriate, subjects might be asked to provide throat swab for viral typing. Subjects with laboratory confirmed H1N1sw influenza might be asked to provide one blood sample (70 mL) within 4 weeks after influenza resolution.

Although this study is not designed nor powered to draw conclusions regarding safety and tolerability, all subjects will be followed, but not analyzed, for safety throughout the study. After vaccination, all subjects will remain under medical supervision at the study site for 30 minutes to be monitored and evaluated for possible immediate hypersensitivity reactions. All study subjects will be instructed on the completion of diary cards to record local and systemic reactions for seven days, starting on the day of vaccination and continuing during the 6 following days. The same diary cards will additionally be used to collect any vaccine-related reactions and any changes in the subject's health (including any serious medical problems such as hospitalizations or any life-threatening medical problems) and any medications taken by the subject throughout the study. All serious adverse events and all adverse events will be recorded throughout the entire trial.

Conditions
Influenza
Being tested
egg-derived A/H1N1 pandemic influenza vaccine
Keywords
Influenza, Vaccines, A/H1N1, Influenza Vaccines
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • egg-derived A/H1N1 pandemic influenza vaccineBiological

    Also called Focetria™

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

Study groups in NCT01079273
Study groupRoleWhat they receive
VaccineActive comparatorAll Subjects enrolled in this study will receive the study vaccine (single-arm)
Receives: Biological: egg-derived A/H1N1 pandemic influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: On day 8, 22, 202 after vaccination

Secondary outcomes (2)

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

    In the interpretation of HI immunogenicity results, the following Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96) for healthy adults will be taken in consideration:

    • The proportion of subjects achieving seroconversion or significant increase in HI antibody titer should be > 40%
    • Mean geometric increase should be > 2.5
    • The proportion of subjects achieving an HI titer ≥ 40 should be > 70%.

    Measured: On day 8, 22, 202 after vaccination

  2. Safety and tolerability

    A medical history will be obtained and physical assessment performed for each subject entered into the study at the time of enrolment and then, a brief physical assessment after every subsequent visit. All subjects will be followed for safety throughout the study. All serious adverse events and all adverse events will be collected throughout the entire trial using diary cards.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01079273
Sponsor's protocol ID
V111_06TP_OPERA
Other IDs
2009-017141-58, 2009
Status last verified
May 2012
First submitted
1 Mar 2010
Last updated
1 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22521851

  • 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.

    PubMed 26136476

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing egg-derived A/H1N1 pandemic influenza vaccine in people with Influenza, run by Opera CRO, a TIGERMED Group Company at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: On day 8, 22, 202 after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01079273, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.

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