Immunogenicity and safety of intradermal influenza vaccine in immunocompromized patients: a meta-analysis of randomized controlled trials

Claudia Pileggi, Francesca Lotito, Aida Bianco, Carmelo G. A. Nobile, Maria Pavia

The primary influenza prevention strategy is focused on annual vaccination according to the categories identified in the various countries as being at greatest risk of complications. Many studies were conducted in order to demonstrate that intradermal (ID) vaccine formulation represents a promising alternative to conventional intramuscular (IM) formulation, especially in subjects with an impaired immune system. However, there is no consensus whether the efficacy and safety of ID is equivalent to IM in these subjects. Therefore, we performed a meta-analysis of Randomized Controlled Trials (RCT) to compare the immunogenicity and safety of ID and IM influenza vaccines in subjects with a depleted immune system. We conducted a search strategy of medical literature published until November 2014 in order to identify RCTs that evaluated the immunogenicity and safety of ID compared with IM influenza vaccines in immunocompromized patients. We identified a total of 269 citations through research in electronic databases and scanning reference lists. Of these, 6 articles were included in the meta-analysis, for a total of 673 subjects. The seroprotection rate induced by the ID vaccine is comparable to that elicited by the IM vaccine. The overall RR was 1.00 (95 % CI = 0.91 -1.10) for A/H1N1 strain, 1.00 (95 % CI = 0.90-1.12) for A/H3N2 and 0.99 (95 % CI = 0.84 -1.16) for B strain. No significant differences in the occurrence of systemic reactions were detected (17.7 % in the ID group vs 18.2 % in the IM group) with a pooled RR = 1.00 (95 % CI = 0.67 -1.51), whereas ID administration caused significantly more injection site reactions with a mean frequency of 46 % in the ID group compared to 22 % in the IM group, with a pooled RR = 1.89 (95 % CI = 1.40 -2.57). The ID influenza vaccine has shown a similar immunogenicity and safety to the IM influenza vaccine in immunocompromized patients, and it may be a valid option to increase compliance to influenza vaccination in these populations.