An open-label randomized study was undertaken to compare a 2-dose regimen (Months 0 and 6) of hepatitis B surface antigen (HBsAg) vaccine formulated with a novel adjuvant (HBsAg/AS04) with a standard 3-dose regimen (Months 0, 1 and 6) of licensed recombinant HBsAg vaccine in terms of immunogenicity and reactogenicity when administered to healthy subjects aged between 15 and 40 y. At 1 and 6 months after the full vaccination course there was a 100% seroprotection rate (anti-HBs > or = 10 mIU/ml) with the HBsAg/AS04 vaccine, compared with a 99% response rate with the licensed vaccine. The corresponding geometric mean titres were significantly higher for the novel vaccine compared to the standard vaccine: 15,468 and 2,745 mIU/ml at Months 7 and 12 vs. 6,274 and 1,883 mIU/ml, respectively. There was a higher prevalence of local symptoms with the adjuvant vaccine (90% of doses) than with the standard vaccine (48% of doses). However, these symptoms (pain, swelling and redness) were predominantly of mild-to-moderate intensity and resolved rapidly without treatment. A 2-dose regimen of the new HBsAg/AS04 adjuvant vaccine therefore compared favourably to the standard regimen in healthy young adults. It is anticipated that the simplified vaccination schedule may improve compliance and reduce costs.
The aim of the study was to investigate present and past morbidity in drug addicts, 25 years after hospitalisation for acute hepatitis B or hepatitis nonA-nonB. The hospital records for 214 consecutively admitted patients were analysed, and a follow-up study on 66 of the 144 patients still alive was performed. At follow-up, 1 of 54 (1.8%) hepatitis B patients was still HBsAg positive. Twelve patients originally diagnosed as hepatitis nonA-nonB were all among 54 found to be anti-hepatitis C virus (anti-HCV) positive, and the total anti-HCV prevalence was 81.8%. Twelve (22.2%) of the HCV cases were unknown before the follow-up examination. Four (6.1%) participants were anti-human immunodeficiency virus positive, only 1 was on antiretroviral therapy, and none had developed AIDS. Other chronic somatic diseases were a minor problem, whereas drug users reported skin infections as a frequent complication. Forty-three patients (65%) had abandoned addictive drugs since the hospital stay. Serious mental disorders were reported by 19 patients (28.8%), and 17 (25.8%) regarded themselves as present (9) and former (8) compulsive alcohol drinkers. A large proportion of the participants were granted disability pension (39%), a majority because of psychiatric disorders, drug and alcohol abuse.
Viral hepatitis has been known to occur among the Greenland population endemically as well as in smaller and larger epidemics. A large epidemic of acute hepatitis comprising around 9% of the entire population, viz. more than 4000 notified cases, swept through Greenland between October 1970 and December 1972. 996 verified cases were seen in the Godthaab district and subjected to more detailed studies. Most of the Godthaab cases were seen among children and adolescents, and no disease was observed in children less than one year of age. Out of 996 diagnosed cases 9 showed acute hepatic failure with coma. Two further cases of hepatic coma were referred for treatment from outside the district. Three of these 11 patients recovered spontaneously. Of the residual 8 cases 6 were treated with exchange transfusions and steroids. Four of these survived and recovered completely. No lasting sequelae had been registered in any of the surviving cases of the epidemic up to June 1975 (2 1/2 years after cessation of the epidemic). Prophylaxis with gamma-globulin was undertaken in a medium-sized settlement in which practically the entire population received gamma-globulin when the first case of hepatitis was diagnosed. In this settlement only 7 out of 297 inhabitants contracted hepatitis. By contrast, in a similar settlement where no gamma-globulin was given, more than 30% of the population developed icteric hepatitis. The clinical features and the prophylactic effect of gamma-globulin seem to indicate that the epidemic was caused by the hepatitis A virus. In accordance with this, transitory Australia-antigenaemia was demonstrated in the acute phase in only 2.6% of the cases, possibly inidicating a small admixture of acute hepatitis type B to the epidemic predominantly caused by hepatitis A virus.