Progress toward a heat- and freeze-stable hepatitis B vaccine

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.

Dear Sir, Can you plese send me a link to your article in Vaccine and a brief how this technology works, I shall be thankful.Regards, Dr. Omesh BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology) Directorate of Health Safety and Regulation,Himachal Pradesh+91-9418120302 [[email protected]][email protected][/email]; [email protected]

Dear Sir, I believe we all will benefit greatly if we can get the link to the document Vaccine vol 27 issue 1. Could you share the link widely please? Regards Abdul-Aziz

Here is the link: Development of a freeze-stable formulation for vaccines containing aluminum salt adjuvants (Vaccine vol. 27, issue:1) LaToya Jones Brauna, Anil Tyagia, Shalimar Perkinsb, John Carpentera, David Sylvesterb, Mark Guyb, Debra Kristensenb and Dexiang Chenb

Thanks a lot. Dr. Omesh BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology) Directorate of Health Safety and Regulation,Himachal Pradesh+91-9418120302 [[email protected]][email protected][/email]; [email protected]

Dear Moderator. Thanks a lot for this. It would be most helpful in understanding the issues. Abdul-Aziz

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. All the best, Debra D. KristensenGroup Leader, Vaccine Technologies, PATH