Comparative immunogenicity of trivalent influenza vaccine administered by intradermal or intramuscular route in healthy adults

Abstract

The present study was undertaken with controls using equal doses ID and IM plus the standard full dose IM to assess the role of route of vaccine in immunogenicity of inactivated influenza vaccine. The study was a prospective, randomized, active-controlled, open label clinical trial conducted in healthy young adult outpatients to compare the effect of route (IM vs ID) on antibody responses to influenza vaccine. Volunteers received 3, 6 or 9 μg of vaccine by ID or IM route; 15 μg IM was also studied. Low doses of vaccine given by either route were almost as immunogenic as the standard 15 μg IM dose of influenza vaccine. ID route was not superior to IM vaccine at inducing antibodies. ID vaccine induced significantly more local inflammatory response than IM vaccine.

A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59®-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration

“…Minimal use of antigenic material is essential to ensure the widest possible availability of both seasonal and pandemic influenza vaccines when supplies are limited by high-demand and restraints in global manufacturing capacity. Consistent with previous studies, 24,26,29,32,37,42 ID vaccination was associated with an increased frequency of mild to moderate local reactions which accompanied the inflammatory process taking place in the skin. For example, injection site erythema was experienced by 92% of subjects in the ID groups compared with 22% and 34% in the IM non-adjuvanted and IM MF59-adjuvanted groups, respectively.…”

“…21 ID delivery of influenza vaccine may be an alternative to conventional intramuscular (IM) injection because the skin is an important natural barrier and immune organ which contains large numbers of Langerhans cells and resident dermal dendritic cells which, as professional antigen-presenting cells, are able to take up antigens at the site of injection, migrate to the draining lymph nodes, and there trigger an effective immune response by activating antigen-specific T cells. 22,23 Although preliminary results of ID vaccination against influenza are promising and have demonstrated good immunogenicity with lower antigen doses compared with IM administration, [24][25][26][27] the traditional ID technique for vaccine delivery (the Mantoux technique) is not easy to perform correctly and requires trained personnel and fine maneuvering of a needle into a 1-2 mm deep layer of tissue. 28 To overcome these limitations, new ID injection devices have been developed to deliver vaccine more reliably and conveniently, which employ short needles (1.5 mm in length), 14,[29][30][31][32] and microneedles (<1.0 mm in length).…”

Intradermal delivery of vaccines: potential benefits and current challenges

“…In these cases it is possible that a reduced dose delivered by the standard route would also have resulted in an equivalent immune response, as has been reported with some influenza vaccines. 26,27 Furthermore, the majority of dose-sparing trials have for reasons of practical simplicity delivered 10% or 20% of the standard dose intradermally. Finer dose-titrations such as those performed with influenza vaccines have shown that less-dramatic reductions in dose, such as a 40% reduction, might be more realistic.…”

MF59®‐adjuvanted vaccines for seasonal and pandemic influenza prophylaxis

“…Therefore, MF59 appears to enhance the immune response to antigens at a number of specific points. Many of these effects have not been reported for other approaches that have been developed for improving vaccine immunogenicity, including alternative adjuvants, virosomal antigen presentation 31 and intradermal vaccination 32 …”