Aspectos prácticos en la evaluación de ensayos clínicos con vacunas profilácticas frente a enfermedades infecciosas

López, Anna; Montané, Eva

doi:10.1016/j.medcli.2010.09.009

Cited by 2 publications

(1 citation statement)

References 7 publications

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“…Las vacunas, al igual que el resto de medicamentos, se someten a ensayos clínicos previos a su comercialización. Durante las fases I, II, III se evalúa su seguridad, inmunogenicidad y eficacia 22 . En una última fase (IV), denominada postcomercialización y de duración mínima de 5 años tras la comercialización de la vacuna, se realiza un seguimiento más exhaustivo en cuanto a su seguridad en la población.…”

Section: Introductionunclassified

Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional: temporadas 2009-2010 y 2010-2011, Comunitat Valenciana

Ramos

Rodrigo

Alonso

et al. 2012

Rev. Esp. Salud Publica

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Section: Introductionunclassified

Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional: temporadas 2009-2010 y 2010-2011, Comunitat Valenciana

Ramos

Rodrigo

Alonso

et al. 2012

Rev. Esp. Salud Publica

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Influence of the Co-Administration of Heptavalent Conjugate Vaccine PCV7-TT on the Immunological Response Elicited by VA-MENGOC-BC® and Heberpenta®-L in Rabbits

Espinosa-Viñals

García-Rivera

Noda

et al. 2017

Immunological Investigations

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Finlay Vaccine Institute is developing a new heptavalent conjugate vaccine against Streptococcus pneumoniae. As infants are the target population, PCV7-TT will be necessarily co-administered with other vaccines, and then, the interactions represent a concern. The aim of this work is to evaluate the possible immunological interferences in rabbits as animal experimental model. Rabbits were immunized with Heberpenta®-L, VA-MENGOC-BC®, and PCV7-TT. Blood samples were taken fourteen days after final immunization for obtaining sera. Antibody responses to all antigens were evaluated by indirect ELISA. Functional responses against diphtheria and tetanus toxoid were done by in vivo seroneutralization assay. No interference was observed by PCV7-TT over the humoral response against diphtheria toxoid and meningococcal antigens (p > 0.05). A nonstatistically significant reduction (p > 0.05) was observed in the case of the humoral response against Haemophilus influenzae type b oligosaccharide. Concomitant administration of Heberpenta®-L and PCV7-TT increased twice the antibody titers as well as the protective activity against tetanus toxoid, but no statistical differences were found. The co-administration did not induce a reduction in the percent of responders against pneumococcal polysaccharides contained in PCV7-TT vaccine. Concomitant administration of PCV7-TT did not induce interferences over the evaluated antigens of Heberpenta®-L and VA-MENGOC-BC®. Also, no interference was observed on the immune response elicited by PCV7-TT. These preclinical results suggest that PCV7-TT will not result in a serious problem over the immune response elicited by the licensed vaccines Heberpenta®-L and VA-MENGOC-BC®. However, the clinical interference could be strictly studied during clinical trials in infants.

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Aspectos prácticos en la evaluación de ensayos clínicos con vacunas profilácticas frente a enfermedades infecciosas

Cited by 2 publications

References 7 publications

Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional: temporadas 2009-2010 y 2010-2011, Comunitat Valenciana

Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional: temporadas 2009-2010 y 2010-2011, Comunitat Valenciana

Influence of the Co-Administration of Heptavalent Conjugate Vaccine PCV7-TT on the Immunological Response Elicited by VA-MENGOC-BC® and Heberpenta®-L in Rabbits

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