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2.
Artigo em Inglês | IMSEAR | ID: sea-135561

RESUMO

Background & objective: A phase 1 trial of adeno-associated virus based HIV-1 subtype C vaccine (tgAAC09) was conducted at two sites in Germany and Belgium and one site in India. This paper reports the safety and immunogenicity of tgAAC09 in healthy adult Indian volunteers. Methods: Between January 2005 and December 2006, 30 consenting volunteers were enrolled in the placebo controlled double-blind dose-escalation trial [3x109, 3x1010 and 3x1011 DNase resistant particles (DRPs)/ml]. Single injection of the candidate vaccine was administered to ten volunteers randomized in 8:2 ratio in vaccine and placebo arms at each dosage level. Results: The mean age of study volunteers (16 men and 14 women) was 34 yr. Six local reactogenicity events and 14 systemic reactogenicity events like malaise, fever, headache and myalgia were reported, both were dose-dependent. The difference between the adverse events reported by vaccine and placebo recipients (79 and 67%) was not significant. A modest IFN-γ ELISPOT response [248 spot forming units (SFU)/million cells] was detected in one volunteer from high dose group and low response (56 and 75 SFU/million cells) in two volunteers in low and mid-dose groups. A post-vaccination dose-dependent increase was observed in anti AAV2 neutralizing titres. None of the volunteers showed a positive antibody response to HIV-1. Interpretation & conclusions: The trial was a benchmark in phase I clinical evaluation of HIV candidate vaccines in India. The vaccine was generally well tolerated and raised no safety concerns. The vaccine was found to be weakly immunogenic. It is essential to understand the role of pre-existing immunity against vectors and significance of evaluation in a prime-boost strategy.


Assuntos
Vacinas contra a AIDS/efeitos adversos , Vacinas contra a AIDS/imunologia , Adulto , Dependovirus/imunologia , Relação Dose-Resposta a Droga , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Ensaio de Imunoadsorção Enzimática , ELISPOT , Feminino , HIV-1/imunologia , Humanos , Índia , Masculino , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/imunologia
4.
J Cancer Res Ther ; 2007 Apr-Jun; 3(2): 92-5
Artigo em Inglês | IMSEAR | ID: sea-111384

RESUMO

Gardasil is the first quadrivalent human papillomavirus (HPV)-types 6, 11, 16, 18 recombinant vaccine approved by the FDA on June 8, 2006. It induces genotype-specific virus-neutralizing antibodies and prevents infection with HPV. Various clinical trials demonstrated a reduction in the incidence of vaccine-type-specific persistent infections and of associated moderate- and high-grade cervical dysplasias and carcinomas in situ after its use. Gardasil is currently approved by FDA for prevention of genital warts, cancers and precancerous conditions of cervix and vulva in 9-26 year old females. Three doses of 0.5 ml of gardasil each at 0, 2 and 6 months are given intramuscularly. It is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine, patients with bleeding abnormalities or patients on anticoagulant therapy and during pregnancy. However, the vaccine, at an estimated $300-500 per course, is too expensive for many women in developing countries. Moreover, question regarding the longevity of the protection by vaccine is still unsolved. Hence, longer studies are required to establish its real status in cancer prevention.


Assuntos
Adulto , Vacinas Anticâncer/efeitos adversos , Carcinoma/tratamento farmacológico , Ensaios Clínicos como Assunto , Feminino , Humanos , Infecções por Papillomavirus/tratamento farmacológico , Vacinas contra Papillomavirus/efeitos adversos , Prevalência , Neoplasias do Colo do Útero/tratamento farmacológico , Vacinas Sintéticas/efeitos adversos
5.
Mem. Inst. Oswaldo Cruz ; 101(7): 749-754, Nov. 2006. graf, tab
Artigo em Inglês | LILACS | ID: lil-439458

RESUMO

The increasing number of pertussis cases reported on the last twenty years and the existence of new acellular vaccines reinforce the need of research for experimental models to assure the quality of available pertussis vaccines. In this study, allotments of whole-cell and acellular pertussis vaccines were tested through the Intranasal Challenge Model (INM) using conventional NIH mice. The results have been compared to those achieved by the "Gold standard" Intracerebral Challenge Model (ICM). In contrast to ICM, INM results did not show intralaboratorial variations. Statistical analysis by Anova and Ancova tests revealed that the INM presented reproducibility and allowed identification and separation of different products, including three-component and four-component accellular pertussis vaccines. INM revealed differences between pertussis vaccines. INM provides lower distress to the mice allowing the reduction of mice number including the possibility of using conventional mice (less expensive) under non-aseptic environment. Thus, INM may be used as an alternative method of verifying the consistence of allotment production, including acellular pertussis vaccines.


Assuntos
Animais , Masculino , Feminino , Camundongos , Bordetella pertussis/imunologia , Vacina contra Coqueluche/imunologia , Coqueluche/imunologia , Administração Intranasal , Modelos Animais de Doenças , Imunidade Celular , Vacina contra Coqueluche/efeitos adversos , Vacina contra Coqueluche/normas , Reprodutibilidade dos Testes , Fatores de Tempo , Vacinas Acelulares/efeitos adversos , Vacinas Acelulares/imunologia , Vacinas Acelulares/normas , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/imunologia , Vacinas Sintéticas/normas , Coqueluche/prevenção & controle
6.
Rev. cuba. estomatol ; 43(2)mayo-ago. 2006.
Artigo em Espanhol | LILACS, CUMED | ID: lil-458786

RESUMO

A pesar de ser la caries dental una de las enfermedades más prevalentes en el ser humano, la Odontología no ha sido capaz todavía de establecer unos estándares para su diagnóstico y tratamiento; la decisión de cuándo y cómo obturar un diente afectado por caries dental está sujeta a una gran variabilidad. Se realiza una revisión bibliográfica con el objetivo fundamental de profundizar en los conocimientos teóricos y prácticos sobre tratamientos preventivos, curativos no invasivos e invasivos utilizados contra esta enfermedad. Se concluye que se deben potenciar los factores remineralizantes y solo cuando una lesión es activa, debe ser obturada, y que las nuevas técnicas de Biología Molecular pueden acelerar las conquistas de vacunas sintéticas(AU)


In spite of being dental caries one of the most prevailing lesions in individuals, Odontology has not yet been able to set some standards for its diagnosis and treatment since the decision of how and when a tooth with caries should be sealed shows great variability. A literature review was made to delve into the theoretical and practical knowledge on preventive and invasive and non-invasive curative treatment used in this type of illness. It was concluded that re-mineralizing factors should be potentiated, an active lesion is the only one that must be sealed and that new Molecular Biology techniques can accelerate the obtaining of synthetic vaccines(AU)


Assuntos
Humanos , Remineralização Dentária/métodos , Cárie Dentária/diagnóstico , Cárie Dentária/epidemiologia , Biologia Molecular/métodos , Padrões de Referência , Literatura de Revisão como Assunto , Vacinas Sintéticas/efeitos adversos
7.
Artigo em Inglês | IMSEAR | ID: sea-45207

RESUMO

A 17 year-old woman developed progressive quadriparesis with bilateral facial diplegia after immunization with recombinant hepatitis B vaccine 3 days prior. Cerebrospinal fluid analysis revealed acellular fluid with high protein level. The electrodiagnosis was compatible with demyelinating polyneuropathy. Other potential causes of Guillain-Barre' syndrome (GBS) were ruled out. Her motor power gradually improved and returned to normal later. The temporal relationship between GBS and vaccination was suggestive of a vaccine-induced cause. Mechanisms of this very rare complication are proposed with a literature review.


Assuntos
Adolescente , Feminino , Síndrome de Guillain-Barré/etiologia , Vacinas contra Hepatite B/efeitos adversos , Humanos , Vacinas Sintéticas/efeitos adversos
9.
Artigo em Inglês | IMSEAR | ID: sea-95180

RESUMO

A pilot study was conducted to assess the clinical safety and immunogenicity of an indigenously developed recombinant hepatitis B vaccine (Shanvac B) in 18 healthy adults. 20 microg of vaccine was administered at 0, 1 and 2 months. Protective anti HBs titres developed in 22%, 77% and 100% one month after 1st, 2nd and 3rd dose of vaccination, respectively. The geometric mean titre after the 3rd dose was 1015.29 mIu/ml. The vaccine was well tolerated with minor local and systemic side effects in 28% and 22%, respectively. The indigenously developed recombinant hepatitis B vaccine is safe, well tolerated and highly immunogenic.


Assuntos
Adolescente , Adulto , Feminino , Anticorpos Anti-Hepatite B/biossíntese , Vacinas contra Hepatite B/efeitos adversos , Humanos , Masculino , Projetos Piloto , Vacinas Sintéticas/efeitos adversos
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