Intradermal 2011/2012 Trivalent Influenza Vaccination - Full Text View

Purpose

Despite the WHO International Health Regulations Emergency Committee declared an end to the 2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has affected more than 214 countries with at least 18000 deaths [http://www.who.int/csr/don/2009_12_30/en/index.html]. Patients with chronic underlying illness and extreme of ages are at risk of developing severe disease and complications [Echevarria-Zuno S 2009, Louie 2009, Jain 2009]. Resistance to oseltamivir has also been reported [Chen 2009]. Therefore, vaccination with the 2011/2012 trivalent influenza vaccine (TIV) with the 2009 H1N1-like virus incorporated will be the best protection against the influenza infection, especially among the at risk population. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination [Van Damme 2009]. The investigators therefore performed a prospective, randomized study to compare the safety and immunogenicity between conventional full dose intramuscular immunization and low dose intradermal immunization of the 2011/2012 TIV.

The investigators plan to evaluate the safety and immunogenicity of low-dose intradermal (ID) 2011/2012 TIV delivered via a novel microneedle device (Intanza 15) and compare this to the full-dose standard intramuscular injection. The investigators hypothesize that ID vaccination will enhance the immunogenicity of the influenza vaccination.

Condition	Intervention
Chronic Illness	Biological: influenza vaccine Drug: Imiquimod Drug: Aqueous cream

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Safety and Efficacy of Intradermal 2011/2012 Trivalent Influenza Vaccination

Resource links provided by NLM:

MedlinePlus related topics: Coping with Chronic Illness Flu

Drug Information available for: Imiquimod Influenza Vaccines

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:

Seroconversion rate [ Time Frame: day 21 ] [ Designated as safety issue: No ]
The percentage of subjects with an hemagglutination inhibition antibody titre <10 at baseline and a post-vaccination titre of ≥40 or a titre >10 at baseline and at least a four-fold increase in titre post-vaccination on day 21

Secondary Outcome Measures:

Geometric mean titer old increase in influenza antibody titer [ Time Frame: day 21 ] [ Designated as safety issue: No ]
The GMT fold increase in influenza antibody titer by hemagglutination inhibition antibody test on day 21 compared to day 0
Seroprotection rate [ Time Frame: day 21 ] [ Designated as safety issue: No ]
The percentage of subjects achieving an antibody titer achieving an influenza antibody titer of 1:40 or above by hemagglutination inhibition antibody test on day 21
Adverse events [ Time Frame: 30 minutes after vaccination ] [ Designated as safety issue: Yes ]
Patients who develop systemic or local adverse events within 30 minutes of vaccination

Enrollment:	91
Study Start Date:	January 2012
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: IM vaccine and placebo cream A single dose of intramuscular influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with aqueous cream	Biological: influenza vaccine single dose of intramuscular 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine Other Name: Vaxigrip Drug: Aqueous cream pretreatment with topical aqueous cream to the injection site before vaccination
Active Comparator: ID vaccine and placebo cream A single dose of intradermal influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with aqueous cream	Biological: influenza vaccine single dose of intradermal 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine Other Name: Intanza 15 Drug: Aqueous cream pretreatment with topical aqueous cream to the injection site before vaccination
Experimental: ID vaccine and imiquimod cream A single dose intradermal influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with imiquimod cream applied to the skin before vaccination	Biological: influenza vaccine single dose of intradermal 15 mcg non-adjuvanted 2011/2012 trivalent influenza vaccine Other Name: Intanza 15 Drug: Imiquimod pretreatment with topical imiquimod cream to the injection site before vaccination Other Name: Aldara

Detailed Description:

See below

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All adult patients at the age of 21 or above with chronic illness and given written informed consent
Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria:

Clinically significant immune-related diseases or significant recent co-morbidities
Inability to comprehend and to follow all required study procedures
History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
Have received 2011/2012 TIV
Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients.
Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
Female of childbearing potential, not using any acceptable contraceptive methods for at least 2 months prior to study entry or that do not plan to use acceptable birth control measures during the first 3 weeks after vaccination.
Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
Have an active neoplastic disease or a history of any hematologic malignancy.
Have long-term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed).
Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
Have known active human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection or autoimmune hepatitis and cirrhosis.
Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
History of progressive or severe neurological disorders Have received any licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination (only exception being unadjuvanted seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations).
Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination
Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule
Have a history of alcohol or drug abuse in the last 5 years.
Have a history of Guillain-Barré Syndrome. Have any condition that the investigator believes may interfere with successful completion of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508884

Locations

Hong Kong
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong

Sponsors and Collaborators

The University of Hong Kong

Investigators

Principal Investigator:

Ivan FN Hung, MD FRCP

The University of Hong Kong

More Information

No publications provided

Responsible Party:	Dr Ivan FN Hung, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT01508884 History of Changes
Other Study ID Numbers:	HKU-2012-432
Study First Received:	January 9, 2012
Last Updated:	April 16, 2013
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:

intradermal
influenza
vaccination

Additional relevant MeSH terms:

Chronic Disease
Influenza, Human
Disease Attributes
Pathologic Processes
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on May 19, 2013