Progress toward a heat- and freeze-stable hepatitis B vaccine
Posted: Wed Aug 05, 2009 1:21 am
In partnership with Arecor and the University of Colorado Denver School of Pharmacy, PATH published findings in this month’s issue of Human Vaccines (volume 5, issue 8) that describe a new hepatitis B vaccine formulation exhibiting nine week stability at 55°C and at least six month stability at both 37°C and 45°C. The data indicate that the new hepatitis B vaccine formulation will be better able to withstand disruption in the cold chain and could potentially be stored at controlled room temperature for a significant part of its shelf life.
Additionally, PATH scientists and partners combined the heat-stable hepatitis B vaccine formulation with the freeze-protection technology developed earlier this year. In collaboration with Arecor and the University of Colorado Denver School of Pharmacy, PATH tested this new hepatitis B vaccine formulation and found it to be heat-stable for 12 months at 37°C in addition to proving freeze-stable at −20°C. According to research findings recently published in Vaccine (volume 27, issue 34), this freeze- and heat-stable formulation was found to be well tolerated in animal models without any significant local or systemic side effects.
To date, PATH and collaborators have completed additional laboratory and preclinical studies validating the science and technology behind the new heat- and freeze-stable hepatitis B vaccine formulations. A commercial vaccine producer is in the process of applying the formulation methods to the development of a second-generation hepatitis B vaccine. Key clinical trials of this new product are scheduled for early 2010.
The development of these formulation methods and the research described in both published studies were conducted in conjunction with PATH’s broad project work in vaccine stabilization, funded by the Bill & Melinda Gates Foundation.
Progress toward a heat- and freeze-stable hepatitis B vaccine
Posted: Wed Aug 12, 2009 2:13 am
In reply to Dr. Bharti's question about the applicability of the stabilization technologies to DPT and pentavalent vaccine:
The freeze stabilization technology should be broadly applicable to any vaccine containing aluminum adjuvant. We have preliminary laboratory data validating this for DPT and pentavalent vaccines. At the beginning of 2009, we published an article in Vaccine (volume 27, issue 1) on the technology that includes these data. The article is entitled "Development of a freeze-stable formulation for vaccines containing aluminum salt adjuvants". We especially hope that vaccine producers will consider this technology when formulating new vaccines with aluminum adjuvant as it should not add cost to the vaccines and PATH has placed the technology in the public domain for broad access.
Heat stabilization is more complex, especially with a multivalent vaccine. We are working on heat stabilization improvements to pentavalent vaccine, but the stability will always be limited by the least stable component - usually pertussis or Hib. We continue to work on stabilizing these vaccines with collaborators.
Last edited by moderator on Mon Aug 17, 2009 8:22 am; edited 1 time in total
Progress toward a heat- and freeze-stable hepatitis B vaccine
Posted: Tue Sep 01, 2009 7:47 am
This is very exciting news. It would be helpful to understand the requirements for the clinical trials for 2nd generation products. Are these small non-inferiority studies or larger trials? In other words, are the financial barriers relatively small or large to developing such heat stable 2nd gen products? Thanks, Steven Wiersma, WHO
Progress toward a heat- and freeze-stable hepatitis B vaccine
Posted: Wed Sep 09, 2009 5:26 am
Dear Steve:
Good question. Phase 3 bridging studies comparing the immunogenicity and safety of the new vaccine to the reference vaccine should be the norm to make these types of changes to second-generation vaccine products. We are looking at trials involving between 300 and 500 subjects. Yes, this is a costly endeavor. However, it is important that the stabilization methods be applied to at least a few existing products to pave the way for others. We strongly recommend that the stabilization approaches be considered during the initial development of vaccines to avoid having to reformulate.
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