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.
Subject(s)
Chickenpox Vaccine/administration & dosage , Measles-Mumps-Rubella Vaccine/administration & dosage , Chickenpox/prevention & control , Chickenpox Vaccine/adverse effects , Chickenpox Vaccine/immunology , Double-Blind Method , Female , Humans , Immunization Schedule , Infant , Male , Measles/prevention & control , Measles-Mumps-Rubella Vaccine/adverse effects , Measles-Mumps-Rubella Vaccine/immunology , Mumps/prevention & control , Rubella/immunology , Rubella/prevention & control , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunologyABSTRACT
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.
Subject(s)
Humans , Rubella , Bacterial Vaccines/supply & distribution , Immunogenicity, Vaccine/immunology , Measles virus , Clinical TrialABSTRACT
The purpose of this study was to investigate the phylogenetic relationship of the Juquitiba virus (JUQV) carried by Oligoryzomys nigripes in endemic and non-endemic areas of Brazil. Wild rodents infected with the Juquitiba virus (JUQV) were sampled from a non-Hantavirus Cardiopulmonary Syndrome endemic area in Brazil. Three strains from O. nigripes were identified by the sequencing of the complete S segment and compared to previous studies of JUQV available in GenBank. The phylogenetic analysis of the complete S segment revealed two distinct clades; the first clade was composed of the JUQV from two non-endemic areas in Brazil and the second clade contained JUQV strains from Argentina, Paraguay and other Brazilian endemic areas.
Subject(s)
Arvicolinae/virology , Orthohantavirus/classification , Viral Proteins/genetics , Amino Acid Sequence , Animals , Bayes Theorem , Brazil , Orthohantavirus/genetics , Molecular Sequence Data , Phylogeny , Sequence AlignmentABSTRACT
An ecological assessment of reservoir species was conducted in a rural area (Jaborá) in the mid-west of the state of Santa Catarina in southern Brazil, where hantavirus pulmonary syndrome is endemic, to evaluate the prevalence of hantavirus infection in wild rodents. Blood and tissue samples were collected from 507 rodents during seven field trips from March 2004 to April 2006. Some of the animals were karyotyped to confirm morphological identification. Phylogenetic reconstructions of rodent specimens, based on the mitochondrial DNA cytochrome b gene sequences, were also obtained. Hantavirus antibody was found in 22 (4.3%) of the 507 rodents: 5 Akodon montensis, 2 Akodon paranaensis, 14 Oligoryzomys nigripes, and 1 Sooretamys angouya. Viral RNAs detected in O. nigripes and A. montensis were amplified and sequenced. O. nigripes virus genome was 97.5% (nt) and 98.4% (nt) identical to sequences published for Araucaria (Juquitiba-like) virus based on N and G2 fragment sequences. Viral sequences from A. montensis strain showed 89% and 88% nucleotide identities in a 905-nt fragment of the nucleocapsid (N) protein-coding region of the S segment when it was compared with two other Akodontine rodent-associated viruses from Paraguay, A. montensis and Akodon cursor, respectively. Phylogenetic analysis showed the cocirculation of two genetic hantavirus lineages in the state of Santa Catarina, one from O. nigripes and the other from A. montensis, previously characterized in Brazil and Paraguay, respectively. The hantavirus associated with A. montensis, designed Jaborá virus, represents a distinct phylogenetic lineage among the Brazilian hantaviruses.
Subject(s)
Antibodies, Viral/blood , Endemic Diseases , Hantavirus Pulmonary Syndrome/epidemiology , Orthohantavirus/genetics , Rodent Diseases/virology , Sigmodontinae , Animals , Base Sequence , Brazil/epidemiology , Capsid Proteins/genetics , Cytochromes b/genetics , DNA, Mitochondrial/chemistry , DNA, Mitochondrial/genetics , Disease Reservoirs/virology , Female , Genetic Variation , Orthohantavirus/classification , Orthohantavirus/immunology , Hantavirus Pulmonary Syndrome/virology , Male , Molecular Sequence Data , Phylogeny , Prevalence , RNA, Viral/blood , Rodent Diseases/epidemiology , Sequence Analysis, DNA , Sigmodontinae/classification , Sigmodontinae/genetics , Sigmodontinae/virology , Viral Core Proteins/genetics , Viral Proteins/geneticsABSTRACT
A cross-sectional serosurvey was conducted to assess the proportion of persons exposed to hantaviruses in a virus-endemic area of the state of Minas Gerais, Brazil. Findings of this study suggested the presence of > or =1 hantaviruses circulating in this region causing hantavirus pulmonary syndrome, mild disease, or asymptomatic infection.
