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ISSN 1027-2852 (Electronic)
ISSN 0864-4551 (Print)

2019, Number 2

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Biotecnol Apl 2019; 36 (2)

Virulence in mice of a cryopreserved bank of the toxigenic strain Vibrio cholerae 3008 to be used as challenge in efficacy studies of vaccine candidates in humans

Proenza-Alfonzo LL, Marrero-Domínguez K, Ledón-Pérez TY, Hernandez-Fundora M, Pérez-Sanchidrian E, Paiffer-Baños N, Díaz-Antúnez D, Reyes-Rojas R, Fando-Calzada RA

Language: English
References: 25
Page: 2111-2115
PDF size: 345.02 Kb.


ABSTRACT

Experimental models of Vibrio cholerae infection in humans (challenge studies) allow evaluating the efficacy of cholera vaccine candidates before carrying out phase III trials. To improve the consistency between the challenge studies, models that use an inoculum prepared directly from a cryopreserved standardized bank have been validated. To evaluate the protection conferred by vaccine strains derived from the strains of the Latin American epidemic of 1991, a challenge test was developed with the toxigenic strain V. cholerae 3008, prepared from a fresh culture. The main objective of the present study was to evaluate the virulence of a cryopreserved bank of the V. cholerae 3008 strain, to validate its use in human challenge studies. The viability of the cryopreserved strain was 1.35 ± 0.15 × 109 c.f.u./ mL. The virulence of strain 3008 and the toxigenic controls N16961 and C7258 was evaluated in the cholera suckling mouse model of infection, confirming the death of 100 % of the inoculated animals. The administration of the bank together with two different antacid solutions it also caused a lethal effect in all the inoculated mice. These results indicate that the freezing of V. cholerae does not affect its virulence and that the cryopreserved bank possesses adequate power in the model used. The results achieved, together with previous experiences, support the use of lots of V. cholerae 3008 cryopreserved for challenge studies in humans, as has been described for other El Tor and O139 strains.


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