ABSTRACT
This phase II clinical trial was conducted to compare the immunogenicity and safety of a newly developed tetanus-reduced diphtheria (Td) vaccine (GC1107-T5.0 and GC1107-T7.5) and control vaccine. This study was also performed to select the proper dose of tetanus toxoid in the new Td vaccines. Healthy adolescents aged between 11 and 12 yr participated in this study. A total of 130 subjects (44 GC1107-T5.0, 42 GC1107-T7.5 and 44 control vaccine) completed a single dose of vaccination. Blood samples were collected from the subjects before and 4 weeks after the vaccination. In this study, all subjects (100%) in both GC1107-T5.0 and GC1107-T7.5 groups showed seroprotective antibody levels (> or = 0.1 U/mL) against diphtheria or tetanus toxoids. After the vaccination, the geometric mean titer (GMT) against diphtheria was significantly higher in Group GC1107-T5.0 (6.53) and GC1107-T7.5 (6.11) than in the control group (3.96). The GMT against tetanus was 18.6 in Group GC1107-T5.0, 19.94 in GC1107-T7.5 and 19.01 in the control group after the vaccination. In this study, the rates of local adverse reactions were 67.3% and 59.1% in GC1107-T5.0 and GC1107-7.5, respectively. No significant differences in the number of adverse reactions, prevalence and degree of severity of the solicited and unsolicited adverse reactions were observed among the three groups. Thus, both newly developed Td vaccines appear to be safe and show good immunogenicity. GC1107-T5.0, which contains relatively small amounts of tetanus toxoid, has been selected for a phase III clinical trial.
Subject(s)
Child , Female , Humans , Male , Antibodies, Bacterial/blood , Arthralgia/etiology , Diphtheria/prevention & control , Diphtheria-Tetanus Vaccine/adverse effects , Double-Blind Method , Headache/etiology , Pain/etiology , Tetanus/prevention & control , Treatment Outcome , VaccinationABSTRACT
Estudo longitudinal prospectivo sobre avaliação da ocorrência de reações no sítio de aplicação da vacina dupla adulto contra difteria e tétano (dT) realizado no município de Três Lagoas, MS, no período de setembro a outubro de 2008. Participaram 1291 trabalhadores de uma empresa de construção civil, com idade de 18 a 68 anos, cujas vacinas foram administradas sem antissepsia prévia do local de aplicação. As reações adversas foram avaliadas 48 horas após o procedimento. Diante das avaliações, não se constataram eventos adversos locais pós-vacinação sendo que em apenas dois casos houve relato de linfadenopatia na região axilar. O estudo apresentou evidências que corroboram as recomendações do Ministério da Saúde relativas a essa prática vacinal.
This longitudinal prospective study aimed at assessing the occurrence of reactions to adult diphtheria-tetanus vaccine (dT) in the application site, carried out in Três Lagoas,MS, Brazil between September and October, 2008 Participants totaled 1,291 workers from a civil construction enterprise aged between 18 and 68, who were vaccinated without previous skin antisepsis of the application site. Adverse reactions were evaluated 48 hours after the procedure. The assessment did not show adverse events on the site after vaccination, and only two cases were reported for lymphadenopathy in the axillary region. The study presented evidence that support the recommendations of the Ministry of Health related to this vaccination practice.
Estudio longitudinal prospectivo que objetivó evaluar la ocurrencia de reacciones en el sitio de aplicación de la vacuna doble adulto (dT), realizado en la ciudad de Três Lagoas, MS, Brasil, entre setiembre y octubre de 2008. Participaron 1291 trabajadores de una empresa de construcción civil, con edad entre 18 y 68 años, cuyas vacunas fueron aplicadas sin antisepsia previa del sitio de aplicación. Las reacciones adversas fueron evaluadas 48 horas después del procedimiento. Ante las evaluaciones, no se constataron eventos adversos locales post-vacunación, siendo que solo en dos casos hubo relato de linfadenopatía en la región axilar. El estudio presentó evidencias que corroboran las recomendaciones del Ministerio de la Salud relativas a esa práctica de vacunación.
Subject(s)
Humans , Adult , Communicable Disease Control/methods , Occupational Health Nursing/methods , Injections, Intramuscular/nursing , Occupational Health Services/methods , Diphtheria-Tetanus Vaccine/adverse effects , Antisepsis , Brazil , Prospective Studies , Occupational GroupsABSTRACT
This study was conducted to evaluate the immunogenicity and safety of diphtheria-tetanus (Td) vaccine in adults over 40 yr old who had never received a diphtheria-tetanus-pertussis (DTP) vaccination. A total of 242 subject completed three-doses of Td vaccination and subsequent assays for immunogenicity. Before vaccination, 33.9% and 96.7% participants showed antibody levels of diphtheria and tetanus, respectively, which were below protective level ( or =0.1 U/mL) for diphtheria and tetanus, with an increase to 99.6% and 100% after the third dose. Local and systemic adverse events occurred in 37.9% and 15.5% of the subjects. No serious adverse event requiring an unscheduled hospital visit occurred. In conclusion, three-doses of Td vaccination to unimmunized adults are safe and effective in inducing protective immunity against diphtheria and tetanus.