Is the skin sensitivity test required for administering equine rabies immunoglobulin.

Background. Rabies immunoglobulins are life-saving in patients with severe exposure to rabies. Despite the high degree of purification of equine rabies immunoglobulin (ERIG), the product inserts still recommend a skin sensitivity test before administration of this heterologous serum. A recent WHO recommendation states that there are no scientific grounds for performing a skin test before administering ERIG because testing does not predict reactions and it should be given irrespective of the result of the test. In this conflicting situation, we assessed the use of the skin sensitivity test in predicting adverse events to ERIG. Methods. The data analysed were from the Antirabies Clinic of the Kempegowda Institute of Medical Sciences Hospital, Bengaluru, India. The period of study was 26 months (June 2008–July 2010). The skin sensitivity test was validated by evaluating its sensitivity, specificity, predictability, falsepositive and false-negative results. Results. A total of 51 (2.6%) adverse events were reported in 31 (1.5%) subjects. Most of these were mild to moderate in nature and subsided without medication. There was no serious adverse event. The sensitivity and specificity of the skin sensitivity test to predict an adverse event was 41.9% and 73.9%, respectively. Conclusion. Our experience with the skin sensitivity test suggests that it may not be required before administering ERIGs, as recommended by WHO.

Guillain - Barre syndrome occurring after rabies vaccination

A variety of events are associated with the onset of Guillain-Barre syndrome, including vaccinations and vaccines. These are the swine influenza vaccine, oral poliovirus vaccine and rabies vaccine. Rabies is a uniformly fatal disease. It is preventable if World Health Organization [WHO] guidelines for post exposure treatment [PET] are followed. These include local treatment of wound, passive immunization with rabies immunoglobulins and administration of a efficacious vaccine. Cell culture vaccines are highly immunogenic with fewer side effects, but are costly. For that reason neurotissue vaccines are still widely used in Pakistan, although they are less immunogenic with higher incidence of neuroparalytic complications. We report a case of Guillain-Barre syndrome secondary to sheep brain anti-rabies vaccine in a young boy, who presented with lower limb weakness with total recovery after treatment

Biphasic demyelination of the nervous system following anti-rabies vaccination.

Acute disseminated encephalomyelitis (ADEM) is an acute or subacute condition characterized by widespread multifocal neurological deficits of variable severity. We report a case of a 45-year-old man with ADEM following anti-rabies vaccine (ARV).

Neurological complications of rabies vaccines.

The rabies vaccines containing neural elements are used in some countries including India. We report three cases that presented with various neurological complications following the use of these vaccines. The presenting manifestations included those of encephalitis, radiculitis and acute inflammatory demyelinating polyradiculoneuropathy. These neurological complications are highlighted so that scientific evidence compels the community to discontinue the use of the neural tissue rabies vaccines. Newer generation cell culture rabies vaccines should be preferred over the neural tissue rabies vaccines for post-exposure prophylaxis.

Evaluation of two intradermal vaccination regimens using purified chick embryo cell vaccine for post-exposure prophylaxis of rabies.

BACKGROUND: Post-exposure prophylaxis for rabies with cell culture vaccines by the conventional intramuscular regimen is very expensive. The World Health Organization has advocated two cost-effective intradermal regimens with cell culture vaccines for use in developing countries. We evaluated these two regimens--the 2-site and the 8-site regimens--in terms of immunogenicity, safety and tolerance in people with category I exposure to rabies. METHOD: Eighty-two subjects who had mild category I exposure to rabies were immunized using a purified chick embryo cell vaccine. The first regimen given to 43 subjects, consisted of intradermal administration of 0.2 ml of vaccine at 2 sites on days 0, 3 and 7 and at one site on days 28 and 90. The second regimen, given to 39 subjects, consisted of intradermal administration of 0.1 ml of vaccine at 8 sites on day 0, at 4 sites on day 7 and at one site on days 28 and 90. The mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination. The subjects were followed up for 1 year. RESULTS: Both regimens produced adequate neutralizing antibody titres from day 14 onwards, though the second regimen produced a more rapid antibody response and significantly higher titres (p < 0.001) on all days tested. There were minimal side-effects and both regimens were well tolerated. CONCLUSION: Both the 2-site and 8-site intradermal regimens with purified chick embryo cell vaccine produce adequate levels of neutralizing antibodies but the 8-site regimen appears to be more immunogenic. The feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in India.

Reacciones al tratamiento antirrábico en Ciego de Avila, Cuba. Revisión de 17 años / Reactions to antirabic treatment in Ciego de Avila, Cuba Review of 17 years

Se evaluaron las reacciones al tratamiento antirrábico en la provincia Ciego de Ávila, Cuba, durante el periodo 1981-1997. Se consideraron reacciones vacunales a las manifestadas en pacientes que recibieron o no suero, presentaron pruebas de sensibilidad positiva e incrementaron el cuadro clínico durante la vacunación.Las pruebas de sensibilidad definidas al suero antirrábico en pacientes a los que se les aplicó este biológico resultaron positivas y no se aumentó el cuadro clínico durante la inmunización por vacuna. En la etapa analizada, el sistema de vigilancia detectó 114 reacciones, de ellas 39 (34 por ciento) tuvieron su origen en la aplicación de la vacuna y 75 (66 por ciento) se debieron al suero antirrábico heterólogo. Los inmunógenos utilizados fueron la vacuna antirrábica tipo Fuenzalida (CLR) producida por el Instituto Finlay, de la República de Cuba; el suero heterólogo equino del Instituto Mesnikov, de Rusia; y la gammaglobulina antirrábica homóloga de los laboratorios Berna, de Suiza. Predominaron las reacciones vacunales locales sobre las sistémicas. Se presentaron cuatro reacciones neuroparalíticas; uno de los pacientes falleció.De las reacciones al suero, 52 por ciento fueron locales y 48 por ciento sistémicas. No se presentaron reacciones a la gammaglobulina antirrábica humana.

Immunogenicity and safety of purified Vero-cell rabies vaccine in severely rabies-exposed patients in China.

The immunogenicity and safety of a purified Vero-cell rabies vaccine (PVRV, VERORAB; Aventis Pasteur, France) were evaluated in 171 patients treated for severe exposure to rabies (WHO category III contacts) at the Shandong Provincial Antiepidemic Station in Jinan and an EPI center in Ping Yin, China. Post-exposure treatment consisted of a single dose of equine rabies immunoglobulin (ERIG, 40 IU/kg body weight) on Day (D) 0, and intra-muscular administration of PVRV on D 0, 3, 7, 14 and 28. Antirabies antibody levels were evaluated on D 0, 7, 14, 28, 90 and 180 using the rapid fluorescent focus inhibition test. By D 14 all subjects had seroconverted (> or = 0.5 IU/ml), with a geometric mean titer of 50.3 IU/ml. Antibody titers remained above the seroprotection threshold in all patients for 3 months, and in 98.2% of subjects for 6 months. All patients were still alive 6 months after the start of treatment. PVRV and ERIG were shown to be well tolerated and no serious adverse events were observed. Following PVRV administration, 12 patients (7.0%) had at least one local reaction (mostly pruritus, erythematous rash and pain). Fourteen patients (8.2%) developed local reactions at the site of ERIG administration. Twelve patients (7.0%) developed systemic reactions following post-exposure treatment, the most frequent of which were pruritus, rash and vertigo. This study demonstrates that PVRV is immunogenic and safe in Chinese patients treated according to WHO recommendations for severe rabies exposure.

Gelastic epilepsy possibly following antirabies vaccine.

A case of child with gelastic epilepsy following administration of antirabies vaccine is presented. No associated structural brain could be identified in the patient. Possibility of relationship between antirables vaccine and gelastic epilepsy is discussed.

Post-exposure prophylaxis with purified vero cell rabies vaccine during pregnancy--safety and immunogenicity.

This study was conducted with the main objective of determining the safety and immunogenicity of purified vero cell rabies vaccine (PVRV) during pregnancy. Twenty nine pregnant women exposed to rabies were vaccinated with PVRV as per the Essen regimen advocated by World Health Organization. None of the women experienced any adverse side effects to the vaccine. The intrauterine growth and development monitored by ultrasound examination was found to be normal and the outcome of pregnancy was satisfactory. There were no congenital anomalies in any of the infants born and they were healthy and had normal growth and development during the one year follow-up period. The rabies neutralizing antibody titers from day 14 to day 365 following vaccination in these women was adequate and well above the minimum protective level of 0.5 iu/ml of serum. Protective levels of antibodies were also present in serum of some of the babies tested, for up to 3 months of age. The mothers and infants followed for one year period were doing well at the end of the study period. Consequently, PVRV was found safe and immunogenically efficacious during pregnancy.

Análise de tratamento anti-rábico humano pós-exposição em região da Grande São Paulo, Brasil / Analysis of human anti rabic post exposure treatment in an urban region of Southeastern Brazil

O tratamento de seres humanos expostos ao risco de infecção pelo vírus rábico ainda pode incluir a ocorrência de reações pós-vacinais indesejáveis, tanto de ordem local como geral. A análise sistemática dos informes epidemiológicos de pacientes submetidos a este tipo de tratamento poderá oferecer subsídios para a modificação desta situação. Foram analisados os registros de tratamento dessa zoonose visando à melhoria do seu controle. Métodos - Foram analisadas através do programa EPI Info as fichas de investigação epidemiológica da raiva de 8.758 habitantes do Município de Osasco, SP (Brasil), atendidos no período de 1984 a 1994. A vacina utilizada foi do tipo Fuenzalida & Palacios. Resultados - Constatou-se a existência de maior risco de exposição para os indivíduos do sexo masculino, com cinco a nove anos de idade. As agressões ocorreram com maior freqüência no domicílio da vítima e os cães foram os principais responsáveis. Dos cães e gatos envolvidos, respectivamente 51,0 por cento e 73,2 por cento não haviam sido imunizados mais freqüentes foram: cabeça (36,6 por cento) e membros superiores (35,1 por cento); quando a faixa etária ultrapassava os nove anos as áreas mais acometidas foram membros superiores (45,8 por cento) e membros inferiores (43,7 por cento). Dos pacientes analisados, 26,5 por cento já haviam recebido vacinação anti-rábica anterior e 90,7 por cento procurou a orientação médica em até cinco dias da agressão. Para 41,9 por cento foi prescrita unicamente a vacinação e para 0,05 por cento a soro-vacinação. Conclusões - Houve 11,7 por cento de abandonos a tratamentos e 51,3 por cento foram dispensados do mesmo em função da observação animal. Dos pacientes tratados com vacina ou soro-vacinação houve 0,25 por cento de acidentes pós-vacinais, dos quais 0,3 por cento to tipo neutrológico. Os meses de março, julho, agosto e setembro foram os de maior procura.

Adverse effect versus quality control of the Fuenzalida-Palacios antirabies vaccine

Avaliamos os componentes da vacina anti-rabica tipo Fuenzalida-Palacios que e ainda utilizada na maioria dos paises em desenvolvimento na imunizacao humana para o tratamento profilatico. Essa vacina e feita em cerebros de camundongos neonatos diluida a 1 por cento, apesar de ser considerada uma vacina com pouco teor de mielina, no entanto ela nao e totalmente livre de mielina, bem como de outros componentes indesejaveis que podem desencadear efeitos adversos a vacinacao, o efeito mais grave esta relacionado com o acidente neuroparalitico pos vacinal associado a sindrome de Guillain Barre. Neste trabalho demonstramos como as vacinas produzidas e distribuidas pelos diversos laboratorios produtores apresentam padroes diferentes de seus componentes com diversos graus de impurezas e com concentracoes proteicas tambem variadas, demonstrando que os processos de producao podem variar em cada laboratorio e que essas diferencas que poderiam ser controladas por meio de um melhor controle de qualidade podem afetar e comprometer a imunizacao acarretando em riscos e efeitos adversos apos a utilizacao dessas vacinas

Five-year longitudinal study of efficacy and safety of purified Vero cell rabies vaccine for post-exposure prophylaxis of rabies in Indian population.

Three hundred and nine (309) persons, vaccinated against rabies with Purified Vero-cell Rabies (PVR) vaccine from 1991-1995, were included in this five-year longitudinal study. This study was conducted to observe the consistency, immunogenicity, inocuity, safety and efficacy of this vaccine under field conditions. All the 309 persons attended our centre after taking post-exposure vaccination following bites by suspected rabid animals or contact with hydrophobia patients for antirabies antibody titre estimation. The vaccine was very well tolerated by vaccinees with only 7 per cent, complaining of mild to moderate side reactions. On an average, every year 70-100 vaccinees reported at this centre after PVR vaccination. The epidemiological characteristics of rabies based on above data are also discussed in this paper. Serological response, i.e., antirabies antibody titre following vaccination in all these persons were found to be satisfactory with mean antibody titre of 4.25 I.U./ml.