Your browser doesn't support javascript.
loading
Immune response to hepatitis B vaccine with high antigen content in non-responders after standard primary vaccination in Chinese adults.
Pan, Hong-Xing; Zeng, Ying; Song, Xue-Fang; Zhang, Yi-Ju; Xu, Ke; Liang, Zheng-Lun; Zhu, Feng-Cai.
Afiliação
  • Pan HX; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu, PR China.
  • Zeng Y; Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen 518057, Guangdong, PR China.
  • Song XF; Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen 518057, Guangdong, PR China.
  • Zhang YJ; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu, PR China.
  • Xu K; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu, PR China.
  • Liang ZL; National Institute for Food and Drug Control, Beijing 100050, PR China. Electronic address: lzlun@yahoo.com.
  • Zhu FC; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu, PR China. Electronic address: jszfc@vip.sina.com.
Vaccine ; 32(29): 3706-12, 2014 Jun 17.
Article em En | MEDLINE | ID: mdl-24681228
ABSTRACT
CONTEXT Alternative schedules are needed to provide greater immunogenicity in adults who fail to respond to the standard hepatitis B (HB) vaccine regimen.

OBJECTIVE:

To evaluate the immunogenicity and safety of high antigen content HB vaccine formulations administered to non-responders after routine primary vaccination. DESIGN SETTING, AND

PARTICIPANTS:

This was a phase III, double-blind, controlled clinical trial in China. We enrolled healthy participants (16-60 years old) seronegative for HB surface (HBs) antigen after primary vaccination, who had HBs antibody (anti-HBs) titres <10 mIU/ml at 28 days following routine vaccination with licensed HB vaccine containing 10 µg of antigen. Participants were randomised (221) to receive three booster doses of HB vaccine formulations containing 60 µg, 30 µg or 10 µg of antigen per dose 28 days apart. Blood samples were obtained pre-vaccination and 28 days after each dose to assess immunogenicity. Reactogenicity and safety were evaluated up to 28 days after each vaccine dose.

RESULTS:

Seroconversion rates were ≥ 92.1% and ≥ 87.1% as from the second dose of the 60 µg and 30 µg HB vaccine formulations, respectively, with geometric mean concentrations (GMCs) of ≥ 286.0 mIU/ml and ≥ 164.0 mIU/ml. In the 10 µg HB vaccine group the seroconversion rates were ≥ 83.0% and the GMCs ≥ 110.1 mIU/ml as from the second vaccine dose. All HB vaccine formulations were well tolerated 352/1091 (32.3%) participants reported at least one injection-site or systemic adverse reaction (145/434 [33.4%] from the 60µg group; 138/435 [31.7%] from the 30 µg group and 69/222 [31.1%] from the 10 µg group). Most reactions were mild or moderate and resolved within 24h. No serious adverse events were reported.

CONCLUSION:

Booster vaccination with a three-dose schedule of a high antigen content HB vaccine formulation was immunogenic and well tolerated in healthy adults. Clinicaltrialsgov Identifier NCT01203319.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Imunização Secundária / Vacinas contra Hepatite B / Formação de Anticorpos Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Vaccine Ano de publicação: 2014 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Imunização Secundária / Vacinas contra Hepatite B / Formação de Anticorpos Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Vaccine Ano de publicação: 2014 Tipo de documento: Article