Immunogenicity and safety of the combined vaccine for measles, mumps, and rubella isolated or combined with the varicella component administered at 3-month intervals: randomised study

• Autor(a) principal: Santos, Eliane Matos dos
• Data de Publicação: 2019
• Outros Autores: Noronha, Tatiana Guimarães, Alves, Isabelle Soares, Cruz, Robson Leite de Souza, Ferroco, Clara Lucy de Vasconcelos, Brum, Ricardo Cristiano, Oliveira, Patricia Mouta Nunes de, Siqueira, Marilda Mendonça, Lima, Mariza Cristina, Ramos, Francisco Lúzio de Paula, Bragagnolo, Camila de Marco, Camacho, Luiz Antonio Bastos, Maia, Maria de Lourdes de Sousa
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Digital do Instituto Evandro Chagas (Patuá)
• DOI: 10.1590/0074-02760180517
• Texto Completo: https://patua.iec.gov.br/handle/iec/3619
• topic: Vacinação / métodos; Vacina contra Sarampo-Caxumba-Rubéola / uso terapêutico; Vacina contra Sarampo-Caxumba-Rubéola / efeitos adversos; Imunogenicidade da Vacina / efeitos dos fármacos; Programas de Imunização; Estudos de Validação como Assunto

BACKGROUND Field testing required to license the combined measles, mumps, and rubella (MMR) vaccine must take into account the current recommendation of the vaccine in Brazil: first dose at 12 months and second dose at 15 months of age in combination with a varicella vaccine. OBJECTIVES This study aimed to evaluate the clinical consistency, immunogenicity, and reactogenicity of three batches of MMR vaccine prepared with active pharmaceutical ingredients (API) from Bio-Manguinhos, Fiocruz (MMR-Bio), and compare it to a vaccine (MMR produced by GlaxoSmithKline) with different API. METHODS This was a phase III, randomised, double-blind, non-inferiority study of the MMR-Bio administered in infants immunised at health care units in Pará, Brazil, from February 2015 to January 2016. Antibody levels were titrated by immunoenzymatic assays. Adverse events were recorded in diaries. FINDINGS Seropositivity levels after MMR-Bio were 97.6% for measles, 84.7% for mumps, and 98.0% for rubella. After the MMRV vaccine, seroconversion rates and GMT increased substantially for mumps. In contrast, approximately 35% of the children had no detectable antibodies to varicella. Systemic adverse events were more frequent than local events. CONCLUSION The demonstration of batch consistency and non-inferiority of the Bio-MMR vaccine completed the technology transfer. This is a significant technological achievement with implications for immunisation programs.