Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01508884
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2012-01-09
Brief Title:
Intradermal Trivalent Influenza Vaccine With Imiquimod
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Efficacy and Effectiveness of Intradermal Trivalent Influenza Vaccine With Topical Imiquimod a Double Blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 1 Patients with chronic underlying illness and extreme of ages are at risk of developing severe disease and complications 2-3 Resistance to oseltamivir has also been reported 4 Therefore vaccination with the 20102011 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 6 Poor immunogenicity of the H1N1 2009 component of the trivalent influenza has been reported 7
Study has also suggested the combined intradermal vaccination with local stimulation of dermal antigen presenting cells by applying imiquimod cream Aldara to the injection site which activate antigen presenting cells APC through the toll-like receptor 7 TLR7 may produce better immunogenicity 8
Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma Scientific evidence has demonstrated that after treatment with imiquimod the antigen is processed and presented to cells of the adaptive immune system leading to clearance of the virus and subsequent clearance of the lesions 9 In addition to functional maturation imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes 1011 Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with the antigen of interest has shown to induce enhanced responses towards the administered antigen 12
We therefore performed a prospective double blind randomized controlled study to compare the safety and immunogenicity between intradermal 20112012 TIV immunization with pretreatment of imiquimod cream and conventional full dose intramuscular 20112012 TIV immunization with pretreatment of aqueous cream as control
Study has also suggested the combined intradermal vaccination with local stimulation of dermal antigen presenting cells by applying imiquimod cream Aldara to the injection site which activate antigen presenting cells APC through the toll-like receptor 7 TLR7 may produce better immunogenicity 8
Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma Scientific evidence has demonstrated that after treatment with imiquimod the antigen is processed and presented to cells of the adaptive immune system leading to clearance of the virus and subsequent clearance of the lesions 9 In addition to functional maturation imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes 1011 Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with the antigen of interest has shown to induce enhanced responses towards the administered antigen 12
We therefore performed a prospective double blind randomized controlled study to compare the safety and immunogenicity between intradermal 20112012 TIV immunization with pretreatment of imiquimod cream and conventional full dose intramuscular 20112012 TIV immunization with pretreatment of aqueous cream as control
Detailed Description:
References
1 World Health Organization Influenza A H1N1 - update 95 cited 2010 April 10 Available from httpwwwwhointcsrdon2009_12_30enindexhtml
2 Echevarria-Zuno S Mejia-Arangure JM Mar-Obeso AJ et al Infection and death from influenza A H1N1 virus in Mexico a retrospective analysis Lancet 2009 374 2072-9
3 Louie JK Acosta M Winter K et al Factors associated with death or hospitalization due to pandemic 2009 influenza AH1N1 infection in California JAMA 2009 302 1896-902
4 Jain S Kamimoto L Bramley AM et al Hospitalized patients with 2009 H1N1 influenza in the United States April-June 2009 N Engl J Med 2009 3611935-44
5 Chen H Cheung CL Tai H et al Oseltamivir-resistant influenza A pandemic H1N1 2009 virus Hong Kong China Emerg Infect Dis 2009151970-2
6 Van Damme P Oosterhuis-Kafeja F Van der Wielen M et al Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults Vaccine 200927454-9
7 Myers CA Faix DJ Blair PJ Possible reduced effectiveness of the 2009 H1N1 component of live attenuated influenza vaccine Clin Infect Dis 20111553207-89
8 Roukens R Vossen AC Boland GJ et al Intradermal hepatitis B vaccination in non-responders after topical application of imiquimod Aldara Vaccine 20104288-4293
9 Tyring S Conant M Marini M Van Der Meijden W Washenik K Imiquimod an international update on therapeutic uses in dermatology Int J Dermatol 20024111810-6
10 Burns Jr RP Ferbel B Tomai M Miller R Gaspari AA The imidazoquinolines imiquimod and R-848 induce functional but not phenotypic maturation of human epidermal Langerhans cells Clin Immunol 200094113-23
11 Suzuki H Wang B Shivji GM Toto P Amerio P Tomai MA et al Imiquimod a topical immune response modifier induces migration of Langerhans cells J Invest Dermatol 20001141135-41
12 Thomsen LL Topley P Daly MG Brett SJ Tite JP Imiquimod and resiquimod in a mouse model adjuvants for DNA vaccination by particle-mediated immunotherapeutic delivery Vaccine 20042213-141799-809
1 World Health Organization Influenza A H1N1 - update 95 cited 2010 April 10 Available from httpwwwwhointcsrdon2009_12_30enindexhtml
2 Echevarria-Zuno S Mejia-Arangure JM Mar-Obeso AJ et al Infection and death from influenza A H1N1 virus in Mexico a retrospective analysis Lancet 2009 374 2072-9
3 Louie JK Acosta M Winter K et al Factors associated with death or hospitalization due to pandemic 2009 influenza AH1N1 infection in California JAMA 2009 302 1896-902
4 Jain S Kamimoto L Bramley AM et al Hospitalized patients with 2009 H1N1 influenza in the United States April-June 2009 N Engl J Med 2009 3611935-44
5 Chen H Cheung CL Tai H et al Oseltamivir-resistant influenza A pandemic H1N1 2009 virus Hong Kong China Emerg Infect Dis 2009151970-2
6 Van Damme P Oosterhuis-Kafeja F Van der Wielen M et al Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults Vaccine 200927454-9
7 Myers CA Faix DJ Blair PJ Possible reduced effectiveness of the 2009 H1N1 component of live attenuated influenza vaccine Clin Infect Dis 20111553207-89
8 Roukens R Vossen AC Boland GJ et al Intradermal hepatitis B vaccination in non-responders after topical application of imiquimod Aldara Vaccine 20104288-4293
9 Tyring S Conant M Marini M Van Der Meijden W Washenik K Imiquimod an international update on therapeutic uses in dermatology Int J Dermatol 20024111810-6
10 Burns Jr RP Ferbel B Tomai M Miller R Gaspari AA The imidazoquinolines imiquimod and R-848 induce functional but not phenotypic maturation of human epidermal Langerhans cells Clin Immunol 200094113-23
11 Suzuki H Wang B Shivji GM Toto P Amerio P Tomai MA et al Imiquimod a topical immune response modifier induces migration of Langerhans cells J Invest Dermatol 20001141135-41
12 Thomsen LL Topley P Daly MG Brett SJ Tite JP Imiquimod and resiquimod in a mouse model adjuvants for DNA vaccination by particle-mediated immunotherapeutic delivery Vaccine 20042213-141799-809
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None