RESUMO
A live oral Vibrio cholerae O1 El Tor vaccine, Peru-15 was tested in a double-blind, randomized placebo controlled study for safety and immunogenicity in Phase I and Phase II studies in 240 Bangladeshi children aged 9 months-5 years of age. Two different doses (2x10(7) and 2x10(8)cfu) were tested. Vaccination did not elicit adverse events and the strain was genetically stable. Vibriocidal antibody responses developed in 42/50 (84%) toddlers (2-5 years) and 35/50 (70%) of younger children (9-23 months) and overall 77/100 (77%) who received the high dose. LPS-IgA-antibody responses were seen in 60% of toddlers and 34% of infants; 40% responded with IgA antibodies to cholera toxin. The responses to the reduced dose was lower. These studies demonstrate that Peru-15 at a dose of 2x10(8)cfu is safe and immunogenic in children in Bangladesh.
Assuntos
Vacinas contra Cólera/imunologia , Administração Oral , Anticorpos Antivirais/sangue , Pré-Escolar , Vacinas contra Cólera/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Imunoglobulina A/sangue , Lactente , Lipopolissacarídeos/imunologia , Masculino , Vacinas Atenuadas/imunologiaRESUMO
The number of elderly people is increasing in less-developed countries. Although nutritional deficiencies and infectious diseases are generally more prevalent in resource-poor countries, the health and nutritional status of the elderly in South America in general, and in Ecuador, in particular, remains largely unstudied. The objective of the present study was to assess the nutritional, immunological and health status of elderly Ecuadorians. A cross-sectional study was conducted to evaluate a sample of elderly Ecuadorians with 24 h dietary recalls, biochemical and anthropometric measurements, delayed type hypersensitivity skin response and a health questionnaire. The 145 elders who enrolled had a mean age of 74.3 (SD 6.9) years. Of the subjects, 52 % exhibited BMI >or=25 kg/m(2), whereas 9.1 % had BMI Assuntos
Nível de Saúde
, Hipersensibilidade Tardia/epidemiologia
, Estado Nutricional/fisiologia
, Idoso
, Idoso de 80 Anos ou mais
, Antígenos/imunologia
, Índice de Massa Corporal
, Estudos Transversais
, Dieta
, Equador/epidemiologia
, Feminino
, Inquéritos Epidemiológicos
, Humanos
, Hipersensibilidade Tardia/imunologia
, Masculino
, Micronutrientes/administração & dosagem
, Micronutrientes/sangue
, Pessoa de Meia-Idade
, Pobreza
, Testes Cutâneos
, Saúde da População Urbana
, Vitaminas/administração & dosagem
, Vitaminas/sangue
RESUMO
BACKGROUND: A live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults.METHODs. The study was conducted among adults, by use of a double-blind, randomized, placebo-controlled design. A single dose of Peru-15 (approximately 2 x 108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer.RESULTS. Study treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%--88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to <.001). A lower immunological response against cholera toxin B subunit was detected.CONCLUSIONS. The safety and immunogenicity of this Peru-15 vaccine candidate indicates the usefulness of future studies in Bangladesh, where cholera is endemic.