Resumo

GONZALEZ GRIEGO, Antonio et al. Study of the phase I of antihepatitis B hyperimmune gammaglobulin with or without exclusion criteria. Rev Cubana Invest Bioméd [online]. 2004, vol.23, n.1, pp.5-10. ISSN 0864-0300.

The phase 1 safety of the hyperimmune gamma produced in Cuba against hepatitis B was evaluated in a sample of persons with and without allergy history. A study was conducted with the 7 batches of hyperimmune gammaglobulin obtained in the National Hemoderivatives Center with all the characteristics to be applied to the human being. The study was divided into 2 phases for each batch. In the first phase, hyperimmune gammaglobulin 200 units was administered concurrently with the first and second dose of the antihepatitis B vaccine to 10 living together persons per batch (70 subjects with no family or personal pathological history of type 1 hypersensitivity). In the second phase, the same procedure was carried out among 20 living together persons per batch (140 individuals) that were administered gamma, but they were persons with type I hypersensitivity. All the collective or individual studies were preceded by lectures conducted by professors that took part in this work, which concluded with the obtention of the individual informed consent for all the participants. No undesirable local or systemic effects were observed in any of the subjects included in the study. The inocuity found will allow to continue developing further phases of clinical studies

Palavras-chave : GAMMAGLOBULINS [inmunology]; HEPATITIS B VIRUS [immunology]; HEPATITIS B [immunology]; HEPATITIS B [transmission]; VIRAL HEPATITIS VACCINES [therapeutic use].