RESUMO
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.
Assuntos
Vacinas contra Hepatite A/efeitos adversos , Vacinas contra Hepatite A/normas , Viagem , Adolescente , Adulto , Idoso , Criança , Feminino , Vacinas contra Hepatite A/administração & dosagem , Humanos , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Reino Unido , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/normas , Vacinas Virossomais/administração & dosagem , Vacinas Virossomais/efeitos adversos , Vacinas Virossomais/normasRESUMO
A prospective, randomised, observer-blind, comparative study was performed in healthy adults with a new hepatitis A/typhoid combined vaccine, Viatim, and the marketed Hepatyrix vaccine. Both vaccines induced high levels of protective antibodies, but typhoid responses were higher and hepatitis A responses more rapid with Viatim compared with Hepatyrix. Both vaccines were well tolerated, no serious adverse events (SAEs) occurred, but more Viatim vaccinees had more mild or moderate local reactions (82.7%) than Hepatyrix (53.1%, p < 0.001). In this direct comparison Viatim induced more local reactions, but elicited a more rapid and higher immune response to both antigens than Hepatyrix.