Rate, intensity, and duration of local reactions to a virosome-adjuvanted vs. an aluminium-adsorbed hepatitis A vaccine in UK travellers

SummaryBackgroundTravellers increasingly require hepatitis A virus (HAV) vaccine for overseas travel to highly endemic areas. While the inactivated HAV vaccines currently in use are all highly immunogenic, studies have shown the aluminium-free, virosome-adjuvanted vaccine Epaxal® to possess a superior local tolerability profile. The objective of this study was to analyse the pattern of local reactions caused by the aluminium-free Epaxal® compared with an aluminium-adjuvanted HAV vaccine.MethodsSubjects recruited from travel health centres were randomised in a 4:1 ratio to receive a single dose of either Epaxal® or Havrix® vaccine. Vaccinees noted adverse reactions on a 7-day diary card that was returned by mail to the centre.Results529 adults (⩾16 years) were vaccinated, and 413 (78.1%) subjects returned diary cards, 338 (76.5%) in the Epaxal group and 75 (86.2%) in the Havrix group. Subjects reported fewer local adverse reactions for Epaxal (23.4% vs. 57.3%; p<0.0001). Injection site pain categorised as Grade 2 (painful on movement) or Grade 3 (spontaneously painful) (4.7% vs. 22.7%, p=0.0001) was less frequent in the Epaxal group and resolved more quickly (⩾3 days of pain, 8.6% vs. 22.7%, p=0.0001).ConclusionsThe lower reactogenicity of the virosome-adjuvanted vaccine is an important feature for travellers.