ABSTRACT
Importance: Control of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines. Objective: To evaluate the immunogenicity of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in humans, including the kinetics, magnitude, and phenotype of SARS-CoV-2 spike-specific humoral and cellular immune responses. Design, Setting, and Participants: Twenty-five participants were enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up to assess durability will continue for 2 years. This study was conducted at a single clinical site in Boston, Massachusetts, as part of a randomized, double-blind, placebo-controlled phase 1 clinical trial of Ad26.COV2.S. Interventions: Participants were randomized to receive 1 or 2 intramuscular injections with 5 × 1010 viral particles or 1 × 1011 viral particles of Ad26.COV2.S vaccine or placebo administered on day 1 and day 57 (5 participants in each group). Main Outcomes and Measures: Humoral immune responses included binding and neutralizing antibody responses at multiple time points following immunization. Cellular immune responses included immunospot-based and intracellular cytokine staining assays to measure T-cell responses. Results: Twenty-five participants were randomized (median age, 42; age range, 22-52; 52% women, 44% male, 4% undifferentiated), and all completed the trial through the day 71 interim end point. Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively. By day 57, binding and neutralizing antibodies were detected in 100% of vaccine recipients after a single immunization. On day 71, the geometric mean titers of spike-specific binding antibodies were 2432 to 5729 and the geometric mean titers of neutralizing antibodies were 242 to 449 in the vaccinated groups. A variety of antibody subclasses, Fc receptor binding properties, and antiviral functions were induced. CD4+ and CD8+ T-cell responses were induced. Conclusion and Relevance: In this phase 1 study, a single immunization with Ad26.COV2.S induced rapid binding and neutralization antibody responses as well as cellular immune responses. Two phase 3 clinical trials are currently underway to determine the efficacy of the Ad26.COV2.S vaccine. Trial Registration: ClinicalTrials.gov Identifier: NCT04436276.
Subject(s)
Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunity, Cellular , Immunogenicity, Vaccine , Adult , COVID-19/immunology , COVID-19 Vaccines/administration & dosage , Double-Blind Method , Female , Humans , Immunity, Humoral , Male , Middle Aged , Vaccine Potency , Young AdultABSTRACT
ABSTRACT Objective To investigate the histological influence of waterpipe smoke exposure on lung tissues of Swiss mice during the periods of 7, 15, 30, 60, and 90 days. Methods The sample consisted of 60 animals, divided into 6 groups, one control group, exposed only to air, and the other experimental groups, daily submitted to water pipe smoke for 30 minutes through the whole body system, for 7, 15, 30, 60 and 90 days. After these periods, the mice were euthanized to obtain the tissue samples and subsequent preparation and analysis of histological slides. Results In the slide microscopy, the control group presented normal aspects. In experimental groups, exacerbation of inflammation was observed, there was a increased thickness of intra-alveolar septa, reduced alveolar lumen, areas of ciliary loss, and neovascular formation. And as the animals' exposure to smoke was extended, the progressive exacerbation of these pulmonary changes was noted. Conclusions The exposure to waterpipe smoke stimulates inflammation and cellular changes in lung tissues of Swiss mice and suggests that the longer the animals' exposure period, the more exacerbated this picture will appear.
ABSTRACT
That was a convergent-care study, carried out in a maternity ward in the Southern Region of Brazil from April to May 2009, with the purpose to comprehend the meanings of premature mother-child skin-to-skin contact and relevant nursing contributions. Data were collected through participant observation and interviews involving nine mothers. Four categories were identified: a) predelivery orientation surrounding premature mother-child skin-to-skin contact; b) establishing premature mother-child skin-to-skin contact; c) meanings of premature mother-child skin-to-skin contact for the mother; and d) nursing contributions in establishing premature mother-child skin-to-skin contact. It was concluded that the meanings of premature mother-child skin-to-skin contact attributed by these mothers is positive, and that nursing's contribution in establishing such contact is significant.
Subject(s)
Mother-Child Relations , Neonatal Nursing , Object Attachment , Touch , Adolescent , Adult , Humans , Infant, Newborn , Skin , Time Factors , Young AdultABSTRACT
Tratou-se de uma pesquisa convergente-assistencial, realizada numa maternidade da Região Sul do Brasil entre abril e maio de 2009, objetivando compreender o significado do contato precoce pele-a-pele mãe-filho para o ser-mãe, identificar características do estabelecimento desse contato e contribuições da enfermagem. Os dados foram coletados pela observação participante e entrevista, com nove mães, identificando-se quatro categorias: a) orientações acerca do contato pele-a-pele precoce mãe-filho antes do nascimento; b) estabelecimento do contato precoce pele-a-pele mãe-filho; c) significado do contato pele-a-pele precoce mãe-filho para o ser-mãe; e d) contribuições da enfermagem no estabelecimento do contato precoce pele-a-pele mãe-filho. Conclui-se que o significado do contato precoce mãe-filho atribuído pelas mães é positivo, e a contribuição da enfermagem no estabelecimento desse contato é significativa.
That was a convergent-care study, carried out in a maternity ward in the Southern Region of Brazil from April to May 2009, with the purpose to comprehend the meanings of premature mother-child skin-to-skin contact and relevant nursing contributions. Data were collected through participant observation and interviews involving nine mothers. Four categories were identified: a) predelivery orientation surrounding premature mother-child skin-to-skin contact; b) establishing premature mother-child skin-to-skin contact; c) meanings of premature mother-child skin-to-skin contact for the mother; and d) nursing contributions in establishing premature mother-child skin-to-skin contact. It was concluded that the meanings of premature mother-child skin-to-skin contact attributed by these mothers is positive, and that nursing's contribution in establishing such contact is significant.
Se trató de una investigación convergente asistencial, realizada en una maternidad de la Región Sur de Brasil, entre abril y mayo de 2009, cuyo objetivo es comprender el significado que el contacto precoz piel a piel, madre-hijo, tiene para el ser madre, y además, identificar las características de la creación de ese contacto, así como la contribución de la enfermería para esa relación. La recolección de los datos se hizo por medio de la observación participativa y de entrevistas con nueve madres, identificando cuatro categorías, a saber: a) las orientaciones acerca del contacto precoz piel a piel, madre-hijo, antes del nacimiento; b) la realización del contacto precoz piel a piel, madre-hijo; c) el significado que el contacto precoz piel a piel, madre-hijo, tiene para el ser madre, y d) las contribuciones de la enfermería para la realización del contacto precoz piel a piel, madre-hijo. Se concluye que el significado del contacto precoz madre-hijo asignado por las madres es positivo, y la contribución de la enfermería para la realización de ese contacto es significativa.