A trial of the reactogenicity and immunogenicity of an inactivated hepatitis A vaccine.
Purified, formaldehyde-inactivated and alum-adjuvanted hepatitis A virus (HAV) vaccines have recently become available for clinical trials. The vaccine is administered intramuscularly in a schedule of 0, 1, and 6 months. The aim of the study was to evaluate the reactogenicity and immunogenicity of an inactivated hepatitis A (HA) vaccine. Three groups of volunteers comprised the study population: 28 volunteers without antibody to HAV were given HA vaccine and, for comparison, 43 subjects received hepatitis B vaccine for possible adverse reactions to the HA vaccine; 12 other subjects received immunoglobulin alone. Each 1 ml dose of HA vaccine contained 720 enzyme units or about 100 ng of antigen. Anti-HAV was determined by means of a commercial assay (Abbott Laboratories: HAV-EIA), and by a more sensitive ELISA. No significant adverse reactions were reported. In the group that received HA vaccine, 4 weeks following the first dose all had detectable antibodies (> or = 20 mIU/ml) by the sensitive ELISA. By commercial HAV-EIA, at 20 weeks following the second dose 75.0% had detectable antibodies, and after the third vaccine all had detectable antibodies. This new inactivated HA vaccine is highly immunogenic and had no significant side effects.
Green
M S
MS
Medical Corps, Israel Defense Forces.
Cohen
D
D
Lerman
Y
Y
Sjogren
M
M
Binn
L N
LN
Zur
S
S
Slepon
R
R
Robin
G
G
Hoke
C
C
Bancroft
W
W
D000328:Adult; D004797:Enzyme-Linked Immunosorbent Assay; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology; D006507:Hepatovirus / Q000276:immunology*; D006801:Humans; D008297:Male; D012449:Safety; D016037:Single-Blind Method; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects / Q000276:immunology*
D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D017325:Hepatitis B Vaccines; D015164:Vaccines, Inactivated; D014761:Viral Hepatitis Vaccines