BACKGROUND: Travellers 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. METHODS:Subjects 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. RESULTS:529 adults (> or =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 (> or =3 days of pain, 8.6% vs. 22.7%, p=0.0001). CONCLUSIONS: The lower reactogenicity of the virosome-adjuvanted vaccine is an important feature for travellers.
RCT Entities:
BACKGROUND: Travellers 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. METHODS: Subjects 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. RESULTS: 529 adults (> or =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 (> or =3 days of pain, 8.6% vs. 22.7%, p=0.0001). CONCLUSIONS: The lower reactogenicity of the virosome-adjuvanted vaccine is an important feature for travellers.