User preferences for a mobile application to report adverse events following vaccination.

The passive surveillance system is an important tool in pharmacovigilance of vaccines. However, reporting of adverse events following immunization (AEFI) post-marketing has limitations regarding under-reporting, biased reports and lack of exposure data resulting in imprecise estimates. New mobile application technology may provide an opportunity for an enhanced surveillance. A pre-requisite for the use of new app-based technology is to identify practical challenges and end users' preferences for design of app-features. The objectives were (i) to investigate the recruitment and feasibility of an app-based study in Germany, (ii) to assess individuals' motivation to participate in such a study and (iii) to identify app-features for reporting AEFI. We conducted a cross-sectional study among employees of a financial institution who attended the occupational health office during the seasonal influenza vaccination in November 2017. Participants tested feasibility and assessed an app prototype for AEFI reporting by using a case vignette and a questionnaire. Of the 153 attending employees, 65 (42%) agreed to participate and returned the questionnaire. Twenty-three (63%) rated the experience of reporting AEFI with the app prototype to be positive. Among three features offered for gamification, collecting points was most frequently chosen (n=22, 34%). The main reason for declining participation was the apprehension about data protection (n=28, 43%). Results suggest that the app-based technology was well accepted and is a suitable supplement for AEFI reporting and in our study. A convincing data protection concept is likely to enhance acceptability of such a system.

Immunogenicity and safety of hepatitis A vaccine in liver and renal transplant recipients.

Organ transplant recipients with chronic hepatitis B or hepatitis C virus infection may be at increased risk of fulminant hepatitis A. Liver transplant (LTX) recipients, renal transplant (RTX) recipients, and healthy controls received 2 doses of hepatitis A vaccine 6 months apart. Anti-hepatitis A virus (anti-HAV) seroconversion after the primary dose occurred in 41% of the LTX patients, 24% of the RTX patients, and 90% of the controls. After the booster dose, the respective rates were 97%, 72%, and 100% (P<.001). RTX patients also had significantly lower geometric mean titers (GMTs) of anti-HAV than LTX patients and controls. In the RTX group, the seroconversion rate and GMT were inversely associated with the number of immunosuppressive drugs received by the patients. The vaccine was well tolerated. Hepatitis A vaccine can be recommended to LTX and RTX patients, but the patients should receive a full course of 2 doses before imminent exposure.