An open study of inactivated hepatitis A vaccine (VAQTA) in Taiwanese healthy adult volunteers: safety, tolerability, and immunogenicity.
The safety, tolerability and immunogenicity of inactivated hepatitis A vaccine (VAQTA, Merck and Co. Inc., West Point, PA, USA) were investigated in 28 seronegative healthy adult volunteers. The age range was 25-35 years, and the mean age was 29 years. Two doses of the vaccine, each containing 50 U of hepatitis A virus antigen, were administered into the deltoid region 24 weeks apart. No serious vaccine-related adverse reactions were reported. Four weeks after the first dose, the geometric mean titer (GMT) was 150 mIU/mL, and the seroconversion rate was 100%. Twenty eight weeks after the first dose (4 weeks following the second dose), the GMT was 4576 mIU/mL. This study demonstrated that VAQTA is safe and highly immunogenic in healthy young adults in Taiwan.
Yang
Chin-Ying
CY
Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan, ROC.
Lu
Chun-Yi
CY
Lee
Chin-Yun
CY
Shao
Pei-Lan
PL
Wang
Chung-Yi
CY
Wu
Tsung-Zu
TZ
Huang
Li-Min
LM
D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004361:Drug Tolerance; D005260:Female; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D030041:Hepatitis A virus / Q000276:immunology; D006801:Humans; D008297:Male; D012449:Safety; D013997:Time Factors; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated