[Immunogenicity and tolerance of a combined hepatitis A/B vaccine. Preliminary results with a candidate vaccine].
OBJECTIVE
Active immunization against hepatitis A having been undertaken in Germany since January 1993, a multicentre study was conducted to test, for the first time, immunogenicity of and tolerance to a candidate vaccine against hepatitis A and B.


METHODS
50 healthy volunteers aged 18-40 years, negative for antibodies against hepatitis A (HAV) and B (HBs), received three intramuscular injections of the candidate vaccine (720 EIU of strain HM 175 and 20 micrograms recombinant HBsAg) in a total volume of 1 ml, on day 1 and then, one month and 6 months later.


RESULTS
Four weeks after the first injection the seroprotection rate (percentage of subjects with protective antibody titres) was 90% for HAV and 28% for HBs. The second injection produced seroconversion rates of 98% and 50%, respectively, and after the third one of 100% and 98%. All reported side effects were minor, of short duration and decreased after each injection. After the first injection, effects at the site of injection occurred in 50% of subjects, decreasing to 6% after the third one. The only systemic side effect, headache, occurred in only 4% of subjects and only after the first injection.


CONCLUSIONS
The test vaccine against hepatitis A and B proved to be highly immunogenic, safe and well tolerated.
Kallinowski
B
B
Medizinische Universitätsklinik, Heidelberg.
Bock
H L
HL
Clemens
R
R
Theilmann
L
L
D000293:Adolescent; D000328:Adult; D005260:Female; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D017957:Hepatitis A Virus, Human / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000096:biosynthesis; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D012907:Smoking / Q000276:immunology; D017778:Vaccines, Combined; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; D014761:Viral Hepatitis Vaccines