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Inactivation of hepatitis B virus by three methods: treatment with pepsin, urea, or formalin
Abstract:
Dilutions of human sera containing between 10(3) and 10(5) chimpanzee infectious doses of hepatitis B virus per ml, subtype adr or ayw, were treated with either 1 microgram/ml pepsin at pH 2.0 for 18 hours, 8 M urea for four hours, or 1:4,000 formalin for 72 hours. One ml of the serum containing hepatitis B virus subjected to each of the procedures was inoculated intravenously into one or two susceptible chimpanzees (total of eight chimpanzees). No evidence of hepatitis B infection was detected in weekly serum samples from the chimpanzees during six months of observation. These three procedures are currently applied during manufacture to inactivate HBV which might be present in the hepatitis B vaccine licensed in the United States. The data from this study combined with data documenting that the physical purification of the vaccine is capable of removing hepatitis B virus provide assurance that there is no residual live hepatitis B virus in the vaccine.
Insights
Hepatitis B virus (HBV) in vaccines is inactivated using pepsin, urea, or formalin treatments. Studies show these methods, combined with purification, effectively eliminate infectious HBV, ensuring vaccine safety.
Area of Science:
- Virology
- Vaccinology
- Biotechnology
Background:
- Hepatitis B virus (HBV) poses a significant public health risk.
- Ensuring the safety of the hepatitis B vaccine is paramount.
- Manufacturing processes must inactivate any potential viral contaminants.
Purpose of the Study:
- To evaluate the efficacy of specific inactivation methods for hepatitis B virus.
- To provide data supporting the safety of the United States licensed hepatitis B vaccine.
- To confirm the absence of infectious HBV in the final vaccine product.
Main Methods:
- Human sera containing known titers of HBV were treated with pepsin, urea, or formalin.
- Treated serum was inoculated into susceptible chimpanzees.
- Chimpanzees were monitored for six months for evidence of hepatitis B infection.
Main Results:
- No chimpanzees developed hepatitis B infection after inoculation with treated virus.
- Pepsin, urea, and formalin treatments demonstrated effective inactivation of HBV.
- These methods are currently used in the hepatitis B vaccine manufacturing process.
Conclusions:
- The manufacturing processes, including pepsin, urea, and formalin treatments, effectively inactivate hepatitis B virus.
- Physical purification further removes any residual HBV.
- The hepatitis B vaccine licensed in the United States is free of residual live hepatitis B virus.