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.

Abstract

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.

• Authors: 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
• Journal: Memorias do Instituto Oswaldo Cruz (Mem Inst Oswaldo Cruz) Vol. 114 Pg. e180517 (Mar 07 2019) ISSN: 1678-8060 [Electronic] Brazil
• PMID: 30843921 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Chickenpox Vaccine
• Measles-Mumps-Rubella Vaccine
• Vaccines, Combined
• measles, mumps, rubella, varicella vaccine

Topics

• Chickenpox (prevention & control)
• Chickenpox Vaccine (administration & dosage, adverse effects, immunology)
• Double-Blind Method
• Female
• Humans
• Immunization Schedule
• Infant
• Male
• Measles (prevention & control)
• Measles-Mumps-Rubella Vaccine (administration & dosage, adverse effects, immunology)
• Mumps (prevention & control)
• Rubella (immunology, prevention & control)
• Vaccines, Combined (administration & dosage, adverse effects, immunology)