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.
Medical Corps, Israel Defense Forces.
M S
MS
Green
D
D
Cohen
Y
Y
Lerman
M
M
Sjogren
L N
LN
Binn
S
S
Zur
R
R
Slepon
G
G
Robin
C
C
Hoke
W
W
Bancroft
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