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
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 stud...
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| Format: | Article |
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Fundação Oswaldo Cruz (FIOCRUZ)
2019-03-01
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| Series: | Memorias do Instituto Oswaldo Cruz |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762019000100314&lng=en&tlng=en |
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| author | Eliane Matos dos Santos Tatiana Guimarães Noronha Isabelle Soares Alves Robson Leite de Souza Cruz Clara Lucy de Vasconcellos Ferroco Ricardo Cristiano Brum Patricia Mouta Nunes de Oliveira Marilda Mendonça Siqueira Mariza Cristina Lima Francisco Luzio de Paula Ramos Camila de Marco Bragagnolo Luiz Antonio Bastos Camacho Maria de Lourdes de Sousa Maia |
| author_facet | Eliane Matos dos Santos Tatiana Guimarães Noronha Isabelle Soares Alves Robson Leite de Souza Cruz Clara Lucy de Vasconcellos Ferroco Ricardo Cristiano Brum Patricia Mouta Nunes de Oliveira Marilda Mendonça Siqueira Mariza Cristina Lima Francisco Luzio de Paula Ramos Camila de Marco Bragagnolo Luiz Antonio Bastos Camacho Maria de Lourdes de Sousa Maia |
| author_sort | Eliane Matos dos Santos |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T18:18:21Z |
| format | Article |
| id | doaj.art-96d368de37c945fda2731b05610b0259 |
| institution | Directory Open Access Journal |
| issn | 1678-8060 |
| language | English |
| last_indexed | 2024-03-12T18:18:21Z |
| publishDate | 2019-03-01 |
| publisher | Fundação Oswaldo Cruz (FIOCRUZ) |
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| series | Memorias do Instituto Oswaldo Cruz |
| spelling | doaj.art-96d368de37c945fda2731b05610b02592023-08-02T09:00:10ZengFundação Oswaldo Cruz (FIOCRUZ)Memorias do Instituto Oswaldo Cruz1678-80602019-03-01114010.1590/0074-02760180517S0074-02762019000100314Immunogenicity and safety of the combined vaccine for measles, mumps, and rubella isolated or combined with the varicella component administered at 3-month intervals: randomised studyEliane Matos dos SantosTatiana Guimarães NoronhaIsabelle Soares AlvesRobson Leite de Souza CruzClara Lucy de Vasconcellos FerrocoRicardo Cristiano BrumPatricia Mouta Nunes de OliveiraMarilda Mendonça SiqueiraMariza Cristina LimaFrancisco Luzio de Paula RamosCamila de Marco BragagnoloLuiz Antonio Bastos CamachoMaria de Lourdes de Sousa MaiaBACKGROUND 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762019000100314&lng=en&tlng=envaccineadverse eventsmeaslesmumpsrubellaimmunogenicitysafetyclinical trial |
| spellingShingle | Eliane Matos dos Santos Tatiana Guimarães Noronha Isabelle Soares Alves Robson Leite de Souza Cruz Clara Lucy de Vasconcellos Ferroco Ricardo Cristiano Brum Patricia Mouta Nunes de Oliveira Marilda Mendonça Siqueira Mariza Cristina Lima Francisco Luzio de Paula Ramos Camila de Marco Bragagnolo Luiz Antonio Bastos Camacho Maria de Lourdes de Sousa Maia 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 Memorias do Instituto Oswaldo Cruz vaccine adverse events measles mumps rubella immunogenicity safety clinical trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | vaccine adverse events measles mumps rubella immunogenicity safety clinical trial |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762019000100314&lng=en&tlng=en |
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