A randomized, placebo-controlled, double-blind Phase 2 trial comparing the reactogenicity and immunogenicity of a single ≥2x10(8) colony forming units [cfu] standard-dose versus a ≥2x10(9) cfu high-dose of CVD 103-HgR live attenuated oral cholera vaccine, with Shanchol inactivated oral vaccine as an open label immunologic comparator.

A randomized, placebo-controlled, double-blind Phase 2 trial comparing the reactogenicity and immunogenicity of a single ≥2x10(8) colony forming units [cfu] standard-dose versus a ≥2x10(9) cfu high-dose of CVD 103-HgR live attenuated oral cholera vaccine, with Shanchol inactivated oral vaccine as an open label immunologic comparator. Clin Vaccine Immunol. 2017 Oct 11;: Authors: Sow SO, Tapia MD, Chen WH, Haidara FC, Kotloff KL, Pasetti MF, Blackwelder WC, Traoré A, Tamboura B, Doumbia M, Diallo F, Coulibaly F, Onwuchekwa U, Kodio M, Tennant SM, Reymann M, Lam DF, Gurwith M, Lock M, Yonker T, Smith J, Simon JK, Levine MM Abstract Reactive immunization with a single-dose cholera vaccine that could rapidly (within days) protect immunologically-naïve individuals during "virgin soil" epidemics would facilitate cholera control. One dose of attenuated Vibrio cholerae O1 classical Inaba vaccine CVD 103-HgR (Vaxchora™) containing ≥2x10(8) colony forming units (cfu) induces vibriocidal antibody seroconversion (correlate of protection) in >90% of U.S. adults. A previous CVD 103-HgR commercial formulation required ≥2x10(9) cfu to elicit high seroconversion in developing country populations. We compared vibriocidal responses of Malians (18-45 years old) randomized to ingest a single ≥2x10(8) cfu standard-dose (N=50) or ≥2x10(9) cfu high-dose (N=50) of PaxVax CVD 103-HgR with buffer, or two doses (N=50) of Shanchol™ inactivate...
Source: Clinical and Vaccine Immunology - Category: Allergy & Immunology Authors: Tags: Clin Vaccine Immunol Source Type: research