Giuseppe
Emeritus
Abstract | Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial
Research article
Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial
Jiri Beran, Arvydas Ambrozaitis, Alvydas Laiskonis, Narseta Mickuviene, Patrick Bacart, Yvan Calozet, Etienne Demanet, Stephane Heijmans, Paul Van Belle, Francoise Weber and Camille Salamand
BMC Medicine 2009, 7:13
doi:10.1186/1741-7015-7-13
Published: 2 April 2009
Abstract (provisional)
Background
Intradermal vaccination provides direct and potentially more efficient access to the immune system via specialised dendritic cells and draining lymphatic vessels. We investigated the immunogenicity and safety during 3 successive years of different dosages of a trivalent, inactivated, split-virion vaccine against seasonal influenza given intradermally using a microinjection system compared with an intramuscular control vaccine.
Methods
In a randomised, partially blinded, controlled study, healthy volunteers (1150 aged 18 to 57 years at enrolment) received three annual vaccinations of intradermal or intramuscular vaccine. In Year 1, subjects were randomised to one of three groups: 3ug or 6ug haemagglutinin/strain/dose of inactivated influenza vaccine intradermally, or a licensed inactivated influenza vaccine intramuscularly containing 15ug/strain/dose. In Year 2 subjects were randomised again to one of two groups: 9ug/strain/dose intradermally or 15ug intramuscularly. In Year 3 subjects were randomised a third time to one of two groups: 9ug intradermally or 15ug intramuscularly. Randomisation lists in Year 1 were stratified for site. Randomisation lists in Years 2 and 3 were stratified for site and by vaccine received in previous years to ensure the inclusion of a comparable number of subjects in a vaccine group at each centre each year. Immunogenicity was assessed 21 days after each vaccination. Safety was assessed throughout the study.
Results
In Years 2 and 3, 9ug intradermal was comparably immunogenic to 15ug intramuscular for all strains, and both vaccines met European requirements for annual licensing of influenza vaccines. The 3ug and 6ug intradermal formulations were less immunogenic than intramuscular 15ug. Safety of the intradermal and intramuscular vaccinations was comparable in each year of the study. Injection site erythema and swelling was more common with the intradermal route.
Conclusions
An influenza vaccine with 9ug of haemagglutinin/strain given using an intradermal microinjection system showed comparable immunogenic and safety profiles to a licensed intramuscular vaccine, and presents a promising alternative to intramuscular vaccination for influenza for adults younger than 60 years.
Trial registration: Clinicaltrials.gov NCT00703651.
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<cite cite="http://www.biomedcentral.com/1741-7015/7/13/abstract">Abstract | Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial</cite>Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial
Jiri Beran, Arvydas Ambrozaitis, Alvydas Laiskonis, Narseta Mickuviene, Patrick Bacart, Yvan Calozet, Etienne Demanet, Stephane Heijmans, Paul Van Belle, Francoise Weber and Camille Salamand
BMC Medicine 2009, 7:13
doi:10.1186/1741-7015-7-13
Published: 2 April 2009
Abstract (provisional)
Background
Intradermal vaccination provides direct and potentially more efficient access to the immune system via specialised dendritic cells and draining lymphatic vessels. We investigated the immunogenicity and safety during 3 successive years of different dosages of a trivalent, inactivated, split-virion vaccine against seasonal influenza given intradermally using a microinjection system compared with an intramuscular control vaccine.
Methods
In a randomised, partially blinded, controlled study, healthy volunteers (1150 aged 18 to 57 years at enrolment) received three annual vaccinations of intradermal or intramuscular vaccine. In Year 1, subjects were randomised to one of three groups: 3ug or 6ug haemagglutinin/strain/dose of inactivated influenza vaccine intradermally, or a licensed inactivated influenza vaccine intramuscularly containing 15ug/strain/dose. In Year 2 subjects were randomised again to one of two groups: 9ug/strain/dose intradermally or 15ug intramuscularly. In Year 3 subjects were randomised a third time to one of two groups: 9ug intradermally or 15ug intramuscularly. Randomisation lists in Year 1 were stratified for site. Randomisation lists in Years 2 and 3 were stratified for site and by vaccine received in previous years to ensure the inclusion of a comparable number of subjects in a vaccine group at each centre each year. Immunogenicity was assessed 21 days after each vaccination. Safety was assessed throughout the study.
Results
In Years 2 and 3, 9ug intradermal was comparably immunogenic to 15ug intramuscular for all strains, and both vaccines met European requirements for annual licensing of influenza vaccines. The 3ug and 6ug intradermal formulations were less immunogenic than intramuscular 15ug. Safety of the intradermal and intramuscular vaccinations was comparable in each year of the study. Injection site erythema and swelling was more common with the intradermal route.
Conclusions
An influenza vaccine with 9ug of haemagglutinin/strain given using an intradermal microinjection system showed comparable immunogenic and safety profiles to a licensed intramuscular vaccine, and presents a promising alternative to intramuscular vaccination for influenza for adults younger than 60 years.
Trial registration: Clinicaltrials.gov NCT00703651.
-