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1.
Jpn J Infect Dis ; 72(5): 299-305, 2019 Sep 19.
Artigo em Inglês | MEDLINE | ID: mdl-31155600

RESUMO

Human papillomavirus (HPV)-associated disease is common among men with HPV infection. A quadrivalent HPV (qHPV) vaccine has demonstrated 85.9% efficacy against HPV6/11/16/18-related, persistent (≥ 6 month) infection in a study of Japanese men aged 16-26 years old. Here, we report the results of an open-label study of the immunogenicity and tolerability of the qHPV vaccine (NCT02576054), conducted to bridge findings from Japanese men to Japanese boys aged 9-15 years old. A total of 100 boys completed a three-vaccination regimen (Day 1, and Months 2 and 6), and 99 boys were included in the primary analysis population. The rate of seroconversion at one month after vaccine Dose 3 (Month 7) was high for each type of HPV (anti-HPV6/11/16/18 seroconversion rates [95% CI]: 94.9% [85.5%, 98.3%], 99.0% [94.4%, 100.0%], 99.0% [94.5%, 100.0%], and 99.0% [94.4%, 100.0%], respectively). Moreover, anti-HPV6/11/16/18 geometric mean titers were 482.9 mMU/mL, 1052.8 mMU/mL, 3878.3 mMU/mL, and 1114.5 mMU/mL, respectively. Immune responses to the qHPV vaccine were non-inferior among Japanese boys included in the current study and compared with young Japanese men from a separate study. Injection-site reactions were the most common adverse events, and administration of the vaccine was well tolerated in Japanese boys.


Assuntos
Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18/efeitos adversos , Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18/imunologia , Infecções por Papillomavirus/prevenção & controle , Adolescente , Anticorpos Antivirais/sangue , Grupo com Ancestrais do Continente Asiático , Criança , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18/administração & dosagem , Humanos , Masculino , Soroconversão
2.
J Infect Chemother ; 25(7): 520-525, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30879979

RESUMO

This study for the first time assessed quadrivalent human papillomavirus (qHPV) vaccine effectiveness against HPV6/11/16/18-related high-grade cervical disease in Japanese women (16-26 years old), as previously demonstrated in overseas trials, and vaccine safety in a longer term (48-month) open-label study (NCT01544478). Participants received three doses of qHPV vaccine (Day 1, Month 2, Month 6). Effectiveness endpoints, assessed in the per-protocol population, included incidence of HPV6/11/16/18-related cervical intraepithelial neoplasia (CIN) Grade 2 or worse (CIN Grade 2 and 3, adenocarcinoma in situ, and/or cervical cancer) as primary endpoint and incidence of external genital lesions (EGLs). Disease related to other high-risk HPV types was also assessed. Adverse events (AEs) and serious AEs (SAEs) were collected from Days 1-15 after any vaccination; vaccine-related SAEs, deaths, and new medical conditions were collected throughout the study. A total of 1030 women received at least one vaccination. No cases of CIN2 or worse or EGLs were reported in the per-protocol population. Injection site-related AEs were reported in 14.5% of participants; most were mild and resolved within 15 days. Vaccine-related systemic AEs occurred in 8.6% of participants, most commonly headache (2.3%), malaise (1.7%), and pyrexia (1.3%). There were no vaccine-related SAEs; one participant discontinued due to a vaccine-related AE of mild uticaria. Overall, qHPV vaccine effectiveness against HPV6/11/16/18-related high-grade cervical disease and EGLs was indicated in Japanese women. The vaccine was well-tolerated, without new safety signals throughout the 48-month study period. Findings are consistent with overseas qHPV vaccine pivotal trials. CLINICAL TRIAL REGISTRY: clinicaltrials.gov; NCT01544478.


Assuntos
Neoplasia Intraepitelial Cervical/epidemiologia , Infecções por Papillomavirus/epidemiologia , Vacinas contra Papillomavirus/administração & dosagem , Neoplasias do Colo do Útero/epidemiologia , Vacinação/métodos , Adolescente , Adulto , Neoplasia Intraepitelial Cervical/prevenção & controle , Neoplasia Intraepitelial Cervical/virologia , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Esquemas de Imunização , Incidência , Japão/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/virologia , Vacinas contra Papillomavirus/efeitos adversos , Fatores de Tempo , Neoplasias do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/virologia , Vacinação/efeitos adversos , Adulto Jovem
3.
Vaccine ; 37(12): 1651-1658, 2019 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-30797638

RESUMO

BACKGROUND: The quadrivalent (q) human papillomavirus (HPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, and 18. We report efficacy, immunogenicity, and safety of qHPV vaccine in a Phase 3 study in Japanese men. METHODS: In this randomized, double-blind trial (NCT01862874), Japanese men (aged 16-26 years) were randomized in a 1:1 ratio to receive three doses of qHPV vaccine or placebo (Day 1, Month 2, Month 6). The primary efficacy endpoint was the combined incidence of HPV6/11/16/18-related persistent anogenital infection (detected at ≥2 consecutive visits ≥6 months apart), assessed in the per-protocol population of men who received all three vaccinations, and were seronegative at Day 1 and PCR negative from Day 1 to Month 7 to the relevant HPV type. Results are from the interim and final analyses. RESULTS: In total, 1124 participants were randomized. The vaccine demonstrated 83.3% (95% confidence interval: 24.9, 98.2; p = 0.007) and 85.9% (95% confidence interval: 52.7, 97.3; p < 0.001) efficacy against HPV6/11/16/18-related persistent infection in the interim and final analyses, respectively. Two cases of HPV6/11/16/18-related external genital lesions (condyloma and PIN 1) were observed in the placebo group and none in the qHPV vaccine group at study end. At Month 7, >97% of participants who received qHPV vaccine seroconverted to each of the vaccine HPV types. Most participants remained seropositive at Month 36, although the seropositivity rate declined between Months 7 and 36. Vaccination-related adverse events were reported in 60.8% and 56.5% of participants in the qHPV vaccine and placebo groups, respectively; most commonly mild to moderate injection-site pain, erythema, and swelling. Injection-site pain and swelling were more common with qHPV vaccine than placebo (each p < 0.05). CONCLUSIONS: Results suggest qHPV vaccine is efficacious against HPV6/11/16/18-related persistent infections, immunogenic, and well-tolerated in Japanese men. Clinical trial registration identifier: NCT01862874.

4.
Hum Vaccin Immunother ; 14(8): 1931-1938, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29580133

RESUMO

In the previous study, revaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in a total of 161 elderly subjects (≥70 years of age) who had received the initial vaccination at least 5 years before (range: 5 to11 years) showed an acceptable safety profile and induction of immune responses to the serotypes in PPSV23. The optimal interval between the initial vaccination and revaccination with PPSV23 is of interest to protect elderly from pneumococcal disease over the long-term. In this post-hoc analysis, we analyzed that the immunogenicity and safety of revaccination with PPSV23 by time interval after the initial vaccination. The level of serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic killing activity (OPA) geometric mean titers (GMTs) at 4 weeks after revaccination with PPSV23 in each subgroup based on time interval (5, 6, 7, 8 and 9-11 years) after the initial vaccination were comparable to those after the primary vaccination and vaccine-induced serotype-specific IgG and OPA levels were similar regardless of the time interval after the initial vaccination. There was no difference in the safety profiles among the subgroups. In conclusion, administration of a second dose of PPSV23 at least 5 years after the initial vaccination was immunogenic and well-tolerated in the elderly ≥70 years of age regardless of the time interval after the initial vaccination.


Assuntos
Esquemas de Imunização , Imunização Secundária/métodos , Imunogenicidade da Vacina , Vacinas Pneumocócicas/administração & dosagem , Pneumonia Pneumocócica/prevenção & controle , Streptococcus pneumoniae/imunologia , Idoso , Idoso de 80 Anos ou mais , Anticorpos Antibacterianos/sangue , Anticorpos Antibacterianos/imunologia , Infecções Comunitárias Adquiridas/imunologia , Infecções Comunitárias Adquiridas/microbiologia , Infecções Comunitárias Adquiridas/prevenção & controle , Feminino , Humanos , Imunização Secundária/efeitos adversos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Japão , Masculino , Vacinas Pneumocócicas/efeitos adversos , Vacinas Pneumocócicas/imunologia , Pneumonia Pneumocócica/imunologia , Pneumonia Pneumocócica/microbiologia , Sorogrupo , Streptococcus pneumoniae/genética , Fatores de Tempo
5.
Hum Vaccin Immunother ; 14(7): 1773-1778, 2018 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-29553862

RESUMO

Hepatitis B vaccines are highly effective in preventing hepatitis B virus infection and have been included in the national immunization program of Japan since 2016. Heptavax®-II is one of two hepatitis B vaccine products licensed in Japan, and its manufacturing process is being modified to reduce variability of manufacturing and optimize immunogenicity. In this study (NCT01463683), the immunogenicity and safety of a modified-process hepatitis B vaccine (mpHBV) were compared to those of the licensed Heptavax®-II. Overall, 722 Japanese adults aged 20-to-35 years old were randomized in a 3:3:1 ratio to either the mpHBV subcutaneous (SC) injection group (mpHBV SC), the Heptavax®-II SC injection group (Heptavax®-II SC), or the mpHBV intramuscular (IM) injection group (mpHBV IM). All participants received a 3-dose series of either mpHBV or Heptavax®-II at Day 1, Month 1, and Month 6. Serum antibody to hepatitis B virus surface antigen (anti-HBs) was assayed on Day 1 prior to the first vaccination and Month 7 (1 month Postdose 3). Seroprotection rates in mpHBV SC were non-inferior to that in Heptavax®-II SC and anti-HBs geometric mean titers were numerically higher in mpHBV SC as compared to Heptavax®-II SC. The incidences of injection-site and systemic adverse events (AEs) observed in mpHBV SC were comparable to those in Heptavax®-II SC, except for erythema which was higher in mpHBV SC than in Heptavax®-II SC. Most injection-site and systemic AEs were mild-to-moderate in intensity and there were no reports of vaccine-related serious AEs in any group. IM administration of mpHBV was well-tolerated and more immunogenic compared to SC administration. In conclusion, mpHBV and Heptavax®-II were well-tolerated and elicited satisfactory immune responses for the prevention against hepatitis B virus-associated diseases.


Assuntos
Vacinas contra Hepatite B/imunologia , Imunogenicidade da Vacina , Adulto , Feminino , Hepatite B/prevenção & controle , Anticorpos Anti-Hepatite B/sangue , Antígenos de Superfície da Hepatite B/imunologia , Vacinas contra Hepatite B/administração & dosagem , Humanos , Injeções Intramusculares , Injeções Subcutâneas , Japão , Masculino , Adulto Jovem
6.
J Infect Chemother ; 24(2): 123-129, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29097028

RESUMO

Recurrent Clostridium difficile infection is considered as a significant health care burden. The global study (MODIFY II) of antibody treatment (bezlotoxumab) for the prevention of recurrent C. difficile infection includes Japanese patients (95 subjects); The aim of this subgroup analysis is to report the data obtained from Japanese patients. Patients with C. difficile infection receiving standard of care antibiotic treatment and a single infusion of bezlotoxumab 10 mg/kg, actoxumab 10 mg/kg + bezlotoxumab 10 mg/kg or placebo. Recurrent C. difficile infection through Week 12 was evaluated. In the Full Analysis Set (93 subjects), 91% were older than 65 years of age and 93% were hospitalized at the time of study entry. The standard of care antibiotic for C. difficile infection was metronidazole for 57 subjects and vancomycin for 36 subjects. The recurrent C. difficile infection rate was 46% in the placebo, 21% in the bezlotoxumab (p = 0.0197) and 28% in the actoxumab + bezlotoxumab group. No additive recurrent C. difficile infection-reducing effect with the addition of actoxumab was demonstrated. There were no events representing safety concern in bezlotoxumab. Among 54 clinical isolates of C. difficile as a baseline culture in Japanese patients, the common ribotypes were 052 (28%), 018 (19%), 002 (15%) and 369 (9%). It showed distinctly different distribution from that in the United States and Europe. The superior effect of bezlotoxumab 10 mg/kg in the prevention of recurrent C. difficile infection suggests that the agent will be useful in the rapidly aging Japanese society.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Anticorpos Neutralizantes/uso terapêutico , Infecções por Clostridium/prevenção & controle , Clostridium difficile/imunologia , Idoso , Antibacterianos/uso terapêutico , Anti-Infecciosos/uso terapêutico , Anticorpos Monoclonais/farmacologia , Anticorpos Neutralizantes/farmacologia , Clostridium difficile/efeitos dos fármacos , Método Duplo-Cego , Feminino , Humanos , Japão , Masculino , Metronidazol/uso terapêutico , Placebos , Recidiva , Fatores de Tempo , Vancomicina/uso terapêutico
7.
Jpn J Infect Dis ; 70(4): 368-373, 2017 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-28003597

RESUMO

A 9-valent human papillomavirus (HPV 6/11/16/18/31/33/45/52/58) virus-like particle vaccine (9vHPV) has been proven highly efficacious in preventing anogenital diseases related to HPV, in a pivotal phase III study for women aged 16-26 years. Here, we report the results of an open-label phase III study conducted to bridge the gap between the findings in women aged 16-26 years and Japanese girls aged 9-15 years. All subjects (n = 100) received a 3-dose regimen of 9vHPV vaccine on day 1 and at months 2 and 6. Anti-HPV serological assays were performed on day 1 and at months 7, 12, 24, and 30. At month 7 (4 weeks after the third dose), 100% of the subjects exhibited seroconversion for each type of HPV. Increases in geometric mean of the titers for anti-HPV 6/11/16/18/31/33/45/52/58 in the subjects were similar to those in Japanese women aged 16-26 years in a previous phase III study. Persistence of the anti-HPV response was observed for 2 years after administration of the third dose. In addition, administration of the 9vHPV vaccine was generally well-tolerated in Japanese girls.


Assuntos
Papillomaviridae/imunologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/efeitos adversos , Vacinas contra Papillomavirus/imunologia , Vacinas de Partículas Semelhantes a Vírus/efeitos adversos , Vacinas de Partículas Semelhantes a Vírus/imunologia , Adolescente , Adulto , Anticorpos Antivirais/sangue , Formação de Anticorpos , Grupo com Ancestrais do Continente Asiático , Criança , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Esquemas de Imunização , Vacinas contra Papillomavirus/administração & dosagem , Fatores de Tempo , Vacinas de Partículas Semelhantes a Vírus/administração & dosagem , Adulto Jovem
9.
RNA ; 10(7): 1047-58, 2004 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15208441

RESUMO

Previously, we identified a gene for a noncoding nuclear RNA, termed Ks-1, that is expressed preferentially in a restricted set of neurons in the honeybee brain. In the present study, we identified another novel gene, termed AncR-1, whose transcripts were localized to nuclei in the whole cortex region of the honeybee brain, as a candidate novel noncoding nuclear RNA gene. RNA fluorescent in situ hybridization revealed that AncR-1 and Ks-1 transcripts were located in a distinct portion of a single neural nucleus, suggesting that they have distinct functions in brain neurons. cDNA cloning revealed that the AncR-1 transcripts were up to 7 kb in size, had mRNA-like structures, and were alternatively spliced. The reporter assay using Drosophila SL-2 cells demonstrated that a TATA box-like sequence located -30 bp upstream of the 5' end of AncR-1 cDNA had promoter activity. None of the alternatively spliced AncR-1 cDNA variants contained significant open reading frames, strongly suggesting that AncR-1 transcripts function as novel noncoding nuclear RNAs. Furthermore, in situ hybridization revealed that AncR-1 was expressed not only in the brain but also in the sex organs in the queen and drones and in the hypopharyngeal glands and oenocytes of the worker bees, suggesting that AncR-1 is involved in diverse organ functions. Some of the AncR-1 transcripts enriched in the nuclei of the hypopharyngeal glands were polyadenylated, indicating the presence of mRNA-like AncR-1 transcripts in the nuclei.


Assuntos
Abelhas/genética , Regiões Promotoras Genéticas/genética , RNA/genética , Transcrição Genética/genética , Animais , Sequência de Bases , Abelhas/fisiologia , Núcleo Celular/genética , DNA Complementar/genética , Feminino , Masculino , Dados de Sequência Molecular , Neurônios/fisiologia , Fases de Leitura Aberta/genética , Caracteres Sexuais
10.
Cell Tissue Res ; 316(2): 281-93, 2004 May.
Artigo em Inglês | MEDLINE | ID: mdl-14999560

RESUMO

We have recently identified a tachykinin-related peptide (AmTRP) from the mushroom bodies (MBs) of the brain of the honeybee Apis mellifera L. by using direct matrix-assisted laser desorption/ionization with time-of-flight mass spectometry and have isolated its cDNA. Here, we have examined prepro-AmTRP gene expression in the honeybee brain by using in situ hybridization. The prepro-AmTRP gene is expressed predominantly in the MBs and in some neurons located in the optic and antennal lobes. cDNA microarray studies have revealed that AmTRP expression is enriched in the MBs compared with other brain regions. There is no difference in AmTRP-expressing cells among worker, queen, and drone brains, suggesting that the cell types that express the prepro-AmTRP gene do not change according to division of labor, sex, or caste. The unique expression pattern of the prepro-AmTRP gene suggests that AmTRPs function as neuromodulators in the MBs of the honeybee brain.


Assuntos
Abelhas/genética , Corpos Pedunculados/metabolismo , Taquicininas/metabolismo , Animais , Encéfalo/metabolismo , Expressão Gênica/genética , Hibridização In Situ , Análise de Sequência com Séries de Oligonucleotídeos , Taquicininas/genética
11.
RNA ; 8(6): 772-85, 2002 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-12088150

RESUMO

We identified a novel gene, Ks-1, which is expressed preferentially in the small-type Kenyon cells of the honeybee brain. This gene is also expressed in some of the large soma neurons in the brain and in the suboesophageal ganglion. Reverse transcription-polymerase chain reaction experiments indicated that Ks-1 transcripts are enriched in the honeybee brain. cDNA cloning revealed that the consensus Ks-1 cDNA is over 17 kbp and contains no significant open reading frames. Furthermore, fluorescent in situ hybridization revealed that Ks-1 transcripts are located in the nuclei of the neural cells, accumulating in some scattered spots. These findings demonstrate that Ks-1 encodes a novel class of noncoding nuclear RNA and is possibly involved in the regulation of neural functions.


Assuntos
Encéfalo/metabolismo , Núcleo Celular/metabolismo , RNA não Traduzido/metabolismo , Animais , Sequência de Bases , Abelhas , DNA Complementar , Feminino , Hibridização In Situ , Masculino , Dados de Sequência Molecular , Neurônios/metabolismo , Fases de Leitura Aberta , RNA Mensageiro/metabolismo , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Transcrição Genética
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