Rate, intensity, and duration of local reactions to a virosome-adjuvanted vs. an aluminium-adsorbed hepatitis A vaccine in UK travellers.
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.
Clarke
Paul D
PD
MASTA Travel Health Centre, 52 Margaret Street, London W1W 8SQ, UK.
Adams
Phillip
P
Ibáñez
Rubén
R
Herzog
Christian
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D005260:Female; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000592:standards*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D014195:Travel; D006113:United Kingdom; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards; D022721:Vaccines, Virosome / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards
D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated; D022721:Vaccines, Virosome