IMMUNOGENICITY OF LOW-DOSE INTRAMUSCULAR AND INTRADERMAL VACCINATION WITH RECOMBINANT HEPATITIS B VACCINE

• Published in: Revista do Instituto de Medicina Tropical de São Paulo
• Main Authors: Marília Dalva TURCHI, Celina Maria Turchi MARTELLI, Maria Lúcia FERRAZ, Antonio Eduardo SILVA, Divina das Dores de Paula CARDOSO, Pierpaolo MARTELLI, Lilian Joy W. Antunes OLIVEIRA
• Format: Article in Journal/Newspaper
• Language: English
• Published: Universidade de São Paulo (USP) 1997
• Subjects: Hepatitis B vaccination; Immunzation; Low doses; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic; Pasteur
• Online Access: https://doi.org/10.1590/S0036-46651997000100004; https://doaj.org/article/842f30809a8948f080d779e782fabb72

The study is a randomized trial using recombinant DNA vaccine to determine whether an intramuscular 10 µg dose or intradermal 2 µg induces satisfactory anti-HBs levels compared to the standard dose of intramuscular 20 µg. participants were 359 healthy medical and nurse students randomly allocated to one of the three groups: Group I - IM 20 µg; Group II - IM 10 µg; Group III - ID 2 µg at 0, 1 and 6 months. Anti-HBs titres were measured after complete vaccine schedule by ELISA/Pasteur. Baseline variables were similar among groups and side effects were mild after any dose. Vaccinees in the IM-10 µg group had seroconversion rate and geometric mean titre (GMT 2344 IU L-1), not significant different from the IM-20 µg group (GMT 4570 IU L-1). On the contrary, 21.4% of the ID - 2 µg recipients mount antibody concentration below 10 IU L1 and GMT of 91 IU L-1, a statiscally significant difference compared with the standard schedule IM-20 µg (p < 0.001). A three dose regimen of half dosse IM could be considered an appropriate schedule to prevent hepatitis B in young health adults which is of relevance to the expansion of hepatitis B vaccine programme São relatados os resultados de um ensaio randomizado utilizando vacina de DNA recombinante com o objetivo de determinar se doses de 10 µg intramuscular (IM) ou 2 µg intradérmica (ID) induzem resposta protetora em comparação com a dose padrão 20 µg IM. 359 estudantes de Medicina e Enfermagem que não apresentaram marcador viral da hepatite B foram aleatoriamente alocados para um dos três grupos: Grupo I - 20 µg IM; Grupo II - 10 µg IM; Grupo III - 2 µg ID com esquema vacinal de 0, 1 e 6 meses. Os títulos de anti-HBs foram medidos após completar o esquema vacinal empregando técnica de ELISA (Pasteur). As características de base entre os grupos foram semelhantes e os efeitos colaterais foram leves após qualquer das doses. Os vacinados com 10 µg IM apresentaram taxa de soroconversão e média geométrica de títulos (GMT 2344 IU L-1) não significante diferentes do grupo que recebeu ...