Matthew Garrett PharmD Candidate 2015
It is estimated that around 20 million hepatitis E infections occur every year. The hepatitis E virus causes liver disease and is usually transmitted through contaminated drinking water. The highest prevalence of hepatitis E is seen in eastern Asia. Hepatitis E infection usually resolves in 4-6 weeks and is mainly self-limiting.1 A study published by the Center for Disease Control and Prevention found that hepatitis E accounted for about 10% of pregnancy-related deaths in southeast Asia. There is no Food Drug Administration approved hepatitis E vaccine at the present time.2
|Title: Long-Term Efficacy of a Hepatitis E Vaccine3|
|Design||Randomized, placebo-controlled, phase 3 clinical trial|
|Objective||The efficacy of the hepatitis E vaccine|
|Study groups||Vaccine group
Patients were randomly assigned to receive three doses of either the hepatitis E vaccine (vaccine group) or a hepatitis B vaccine (Beijing Tiantan Biological Products) (control group) and were followed for the occurrence of hepatitis E and serious adverse events.
|Duration||54 months||Primary Outcome Measure||To determine the short-term efficacy of the hepatitis E vaccine|
|Baseline Characteristics||Adults 16 to 65 years|
|Results||The cumulative incidence of hepatitis E was significantly lower in the vaccine group than in the control group (P<0.001 in the modified intention-to-treat analysis). From the study 7 cases were confirmed in the vaccine group (0.3 cases per 10,000 person-years), and 53 cases in the control group (2.1 cases per 10,000 person-years), representing a vaccine efficacy of 86.8%.|
|Adverse Events||Common Adverse Events: Gastrointestinal disorders 1.7%, procedural complications 1.7%, Musculoskeletal and connective tissue disorders 1.4%|
|Serious Adverse Events: : Neoplasms benign, malignant and unspecified 1.6%, Nervous system disorders 0.6%|
|Percentage that Discontinued due to Adverse Evens: Not reported|
|Study Author Conclusions||Immunization with the hepatitis E vaccine induced a sustained level of antibodies and protection against hepatitis E for up to 4.5 years|
After 4.5 years, this phase 3 clinical trial has shown that the hepatitis e vaccine has long-term efficacy versus placebo in preventing hepatitis e infection.
1. WHO | Hepatitis E. 2015. Available at: http://www.who.int/mediacentre/factsheets/fs280/en/. Accessed March 13, 2015.
2. Hepatitis E, a Vaccine-Preventable Cause of Maternal Deaths – Volume 18, Number 9—September 2012 – Emerging Infectious Disease journal – CDC. 2015. Available at: http://wwwnc.cdc.gov/eid/article/18/9/12-0241_article. Accessed March 13, 2015.
3. Zhang J, Zhang XF, Huang SJ, et al. Long-term efficacy of a hepatitis E vaccine. N Engl J Med. 2015;372(10):914-22.