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Development and implementation of standardized method for detecting immunogenicity of acellular pertussis vaccines in Korea
Clinical and Experimental Vaccine Research ; : 35-42, 2019.
Artículo en Inglés | WPRIM | ID: wpr-719489
ABSTRACT

PURPOSE:

There is no standard method for confirming the immunogenicity of acellular pertussis vaccines. We tried to develop a local standard method for evaluating the immunogenicity of the three-component of acellular pertussis vaccines which was developed by a Korean local company. MATERIALS AND

METHODS:

The developed pertussis antigens (pertussis toxin, filamentous hemagglutinin, pertactin) were evaluated by in-house enzyme-linked immunosorbent assay (ELISA) using 189 negative sera, 25 positive sera, and 73 paired sera (pre- and post-Tdap [tetanus, diphtheria, and acellular pertussis] vaccinated sera). ELISA units were calculated by the reference line method, compared with World Health Organization reference sera, and the cut-off value was calculated using negative sera.

RESULTS:

When compared to National Institute for Biological Standards and Control control antigen (NIBSC) control antigens, the developed pertussis toxin (PT) and filamentous haemagglutinin (FHA) antigens were 203.48 and 61.60 IU/µg, respectively. Each in-house ELISA was established by validating the coefficients of variation % (PT, 11.53%; FHA, 8.60%; pertactin [PRN], 9.86%) obtained from the results of inter- and intra-assay variation. Also, the cut-off values of PT, FHA, and PRN were 11.65, 38.95, and 5.66 EU/mL, respectively. The distributions of antibody levels in paired showed that 93.15% (68/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were higher than a 100% increase after vaccination. Additionally, the values of 89.04% (65/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were below each cut-off point.

CONCLUSION:

We established an in-house ELISA method using self-developed antigens, and these immunoassays have provided a way to standardize measuring the immunogenicity of newly developed vaccines, through single- and dual-serology.
Asunto(s)

Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Organización Mundial de la Salud / Inmunoglobulina G / Ensayo de Inmunoadsorción Enzimática / Inmunoensayo / Vacunas / Vacuna contra la Tos Ferina / Tos Ferina / Vacunación / Toxina del Pertussis / Difteria País/Región como asunto: Asia Idioma: Inglés Revista: Clinical and Experimental Vaccine Research Año: 2019 Tipo del documento: Artículo

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Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Organización Mundial de la Salud / Inmunoglobulina G / Ensayo de Inmunoadsorción Enzimática / Inmunoensayo / Vacunas / Vacuna contra la Tos Ferina / Tos Ferina / Vacunación / Toxina del Pertussis / Difteria País/Región como asunto: Asia Idioma: Inglés Revista: Clinical and Experimental Vaccine Research Año: 2019 Tipo del documento: Artículo