重组疫苗:HEPLISAV-B（hepatitis B vaccine[Recombinant],Adjuvanted）在美国25年来第一款获批的乙肝疫苗，也是唯一一个用于成人的双剂量乙肝疫苗。

  近日，美国食品药品监督管理局（FDA）批准其乙型肝炎重组疫苗hepatitis B vaccine（商标名 Heplisav-B，Dynavax公司）用于预防所有已知的HBV亚型引起的18岁以上成年人感染。
　关于Heplisav-B
  Heplisav-B是一种HBV表面抗原与Dynavax专有的Toll样受体9（TLR9）激动剂的组合疫苗，可以增强免疫应答。Heplisav-B在一个月内注射两次，在更短时间内以更少的注射次数完成乙肝疫苗接种。
  相关研究
  Heplisav-B的获批是基于三项3期非劣效性试验的数据，三项试验共纳入了约10 000名接种Heplisav-B的成年受试者，比较了一个月内接种两次Heplisav-B和六个月内接种三次Engerix-B的效果。
  研究结果显示，在最大的一项纳入了6,665名受试者的3期临床试验中，与Engerix-B相比，Heplisav-B的保护率显著提高（95% vs 81%）；同样，在纳入了961例2型糖尿病患者的亚组分析中，Heplisav-B的保护率为90%，显著高于Engerix-B的6%。
　3期临床试验中最常见的局部反应是注射部位疼痛（23%至39%），最常见的全身反应包括疲劳（11%至17%）和头痛（8%至17%）。
  关于对其他疫苗应答率低的特殊人群来说，包括老年患者、糖尿病患者、肥胖者和吸烟者，研究结果表明，在所有小组中，Heplisav小组的保护率明显较高，尤其是在那些对其他疫苗无应答的小组中。
  Dynavax预计将在2018年第一季度在美国商业化推出Heplisav-B。

HEPLISAV-B（hepatitis B vaccine (Recombinant), Adjuvanted）Solution for Intramuscular Injection
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Important Safety Information
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).
INDICATIONS
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. HEPLISAV-B is approved for use in adults 18 years of age and older.
DOSAGE AND ADMINISTRATION
For intramuscular administration.
Dose And Regimen
Administer two doses (0.5 mL each) of HEPLISAV-B one month apart.
Administration
HEPLISAV-B is a clear to slightly opalescent, colorless to slightly yellow solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
Administer HEPLISAV-B by intramuscular injection in the deltoid region using a sterile needle and syringe.
HOW SUPPLIED
Dosage Forms And Strengths
HEPLISAV-B is a sterile solution for injection available in 0.5 mL single-dose vials. [see How Supplied].
Storage And Handling
•Package of 5 single dose vials (NDC number: 43528-002-05)
The vial stoppers are not made with natural rubber latex.
Storage Conditions
Store in a refrigerator at 2°C to 8°C (35°F to 46°F).