A thermostable, dry formulation inactivated Hikojima whole cell/cholera toxin B subunit oral cholera vaccine

• The feared diarrheal disease cholera remains an important global health problem. Use of oral cholera vac-cine (OCV) from a global stockpile against both epidemic and endemic cholera is a cornerstone in the World Health Organisations (WHOs) global program for "Ending cholera by 2030". Three liquid inacti-vated whole-cell OCVs (Dukoral (R), ShancholTM, and Euvichol-Plus (R)) are WHO prequalified and have proved to be safe and effective. However, their multicomponent composition and cold-chain requirement increase manufacturing, storage and transport costs. ShancholTM and Euvichol-Plus (R) OCVs used in WHOs global vaccine stockpile also lack the protective cholera toxin B-subunit (CTB) antigen present in Dukoral (R), which results in suboptimal efficacy.WHOs Global Task Force on Cholera Control (GTFCC) has identified a thermostable, dry formulation vaccine as a priority for further OCV development. We describe here the development of such a vaccine, based on a lyophilized mixture of a single strain of formalin-killed Hikojima bacteria together with a low-cost, recombinantly produced CTB. The new vaccine, which is easy and inexpensive to manufacture, could be stored for at least 26 months at 25 degrees C and for at least 8 months at 40 degrees C with preservation of cell mor-phology and with no loss of protective Ogawa and Inaba lipopolysaccharides or CTB. It also proved to be well tolerated and to have equivalent oral immunogenicity in mice as ShancholTM and Dukoral (R) OCVs with regard to both serum and intestinal-mucosal antibody responses.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Immunology in the medical area (hsv//eng)

Nyckelord

Cholera vaccine

Cholera B subunit

Thermostability

Dry formulation

Mucosal immunity

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