TY - JOUR
T1 - Immunogenicity and reactogenicity of a combined hepatitis A-hepatitis B vaccine in adolescents
AU - Thompson, S C
AU - Norris, M
PY - 1998/10/8
Y1 - 1998/10/8
N2 - OBJECTIVE: To evaluate the immunogenicity and reactogenicity of two lots of a combined hepatitis A-hepatitis B vaccine (HAV, HBV) in healthy 15 to 18 year olds.DESIGN: This was a double-blind, randomized clinical study. Vaccine was administered into the deltoid at 0, 1, and 6 months. Immunogenicity was assessed by anti-HAV and anti-HBs antibody levels at 2, 6, and 7 months after the first vaccine dose. Reactogenicity was assessed through use of 3-day diary cards following each vaccination, plus recording other unsolicited reactions.RESULTS: A total of 160 adolescents were vaccinated; 155 who were seronegative for hepatitis A and B at baseline and who completed the study were included in the immunogenicity analysis. The vaccine was well tolerated; most side effects were local, of low intensity and short duration. Good immunogenicity was determined by antibody titers. High rates of seropositivity (99.4%) were achieved after two doses against HAV, and after three doses for anti-HBs (seroprotection = 98.7%).CONCLUSIONS: This combination vaccine will be useful for immunizing selected high-risk groups in developed countries. In countries where endemicity is low for both diseases, targeting students prior to risk of acquisition would be a feasible preventive strategy.
AB - OBJECTIVE: To evaluate the immunogenicity and reactogenicity of two lots of a combined hepatitis A-hepatitis B vaccine (HAV, HBV) in healthy 15 to 18 year olds.DESIGN: This was a double-blind, randomized clinical study. Vaccine was administered into the deltoid at 0, 1, and 6 months. Immunogenicity was assessed by anti-HAV and anti-HBs antibody levels at 2, 6, and 7 months after the first vaccine dose. Reactogenicity was assessed through use of 3-day diary cards following each vaccination, plus recording other unsolicited reactions.RESULTS: A total of 160 adolescents were vaccinated; 155 who were seronegative for hepatitis A and B at baseline and who completed the study were included in the immunogenicity analysis. The vaccine was well tolerated; most side effects were local, of low intensity and short duration. Good immunogenicity was determined by antibody titers. High rates of seropositivity (99.4%) were achieved after two doses against HAV, and after three doses for anti-HBs (seroprotection = 98.7%).CONCLUSIONS: This combination vaccine will be useful for immunizing selected high-risk groups in developed countries. In countries where endemicity is low for both diseases, targeting students prior to risk of acquisition would be a feasible preventive strategy.
KW - Adolescent
KW - Double-Blind Method
KW - Hepatitis A/immunology
KW - Hepatitis A Antibodies
KW - Hepatitis A Vaccines
KW - Hepatitis Antibodies/blood
KW - Hepatitis B/immunology
KW - Hepatitis B Antibodies/blood
KW - Hepatitis B Vaccines/adverse effects
KW - Humans
KW - Sexually Transmitted Diseases, Viral/prevention & control
KW - Time Factors
KW - Vaccines, Combined/adverse effects
KW - Viral Hepatitis Vaccines/adverse effects
M3 - Article
C2 - 9763500
SN - 1201-9712
VL - 2
SP - 193
EP - 196
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
IS - 4
ER -
