Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium

Costa, Wagner Augusto da; Cunha, Ricardo Siqueira; Bolzan, Vera Lucia; Silva, Andrea de Cássia R.; Caporale, Graciane Maria Medeiros; Chaves, Luciana Botelho; Oselka, Gabriel Wolf; Junqueira, Dulce A.; Panachão, Maria Rosana Issberner; Dias, Ricardo Augusto; Takaoka, Neide Yumie

doi:10.1016/j.vaccine.2007.09.043

Cited by 13 publications

(8 citation statements)

References 17 publications

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“…The losses in some clinical studies with the NIP vaccines were variable (0-54%), having as causes the occurrence of diseases in participants, post-vaccination adverse effects, change of municipality, abandonment of participation in the study, difficulties in finding the family, the administration of other vaccines than the ones scheduled for the study, among others (6)(7)(8)(9)(23)(24)(25) . In studies developed in HCs, the follow-up failures were either zero or very little, even in that study with one thousand participants followed by at least seven months.…”

Section: Discussionmentioning

confidence: 99%

“…In this perspective, several products have been developed in the country, such as the recombinant hepatitis B vaccine (VrHB-IB) produced by the Butantan Institute (BI), the combined vaccines against diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Bio-Manguinhos/Fiocruz/ RJ and BI) and the rabies vaccine produced in Vero cells (BI). Clinical trials that aimed to demonstrate the immunogenicity and safety of these vaccines have shown satisfactory results, allowing the incorporation of these products to the NIP (6)(7)(8)(9) .…”

Section: Introductionmentioning

confidence: 99%

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Estratégias de campo em ensaios clínicos com novas vacinas produzidas no Brasil

Carniel

Antônio

Zanolli

et al. 2012

Rev. paul. pediatr.

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OBJETIVO: Relatar as estratégias de campo utilizadas em dois ensaios clínicos com vacinas desenvolvidas pelo Instituto Butantan, em 2004 e 2006. MÉTODOS: Estudo do tipo relato de experiência, em que se descreve o planejamento e a operacionalização dos ensaios clínicos, que avaliaram a imunogenicidade e a segurança da vacina BCG combinada com a vacina da hepatite B (VrHB-IB) e da tetravalente bacteriana modificada pela extração do lipopolissacarídeo (LPS) do componente pertussis (DTPm/Hib). RESULTADOS: As principais estratégias de campo utilizadas foram: a) Parceria entre os pesquisadores e os gestores da Secretaria Municipal de Saúde e b) Realização dos procedimentos da pesquisa nos domicílios ou nos Centros de Saúde frequentados pelos participantes. No primeiro estudo, foram vacinados 552 recém-nascidos na maternidade com a BCG/VrHB-IB (combinadas ou separadas) e nos domicílios, com as duas doses subsequentes de VrHB-IB. O segundo estudo incluiu 241 lactentes em Centros de Saúde da rede municipal, vacinados com tetravalente bacteriana (com componente pertussis total ou modificado). Em ambos os estudos, amostras de sangue foram colhidas nas residências. Não houve relatos de eventos adversos. A adesão foi de 90,2% para o primeiro estudo e 93,8%, para o segundo. As vacinas foram administradas nas datas preconizadas pelo Programa Nacional de Imunizações e as coletas de sangue, de acordo com o cronograma dos estudos. CONCLUSÕES: As estratégias utilizadas facilitaram o recrutamento das crianças e garantiram cumprir o protocolo da pesquisa com alta adesão, sem interferir no vínculo da família com o Serviço de Saúde, no calendário vacinal ou no seguimento pediátrico dos participantes.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Estratégias de campo em ensaios clínicos com novas vacinas produzidas no Brasil

Carniel

Antônio

Zanolli

et al. 2012

Rev. paul. pediatr.

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“…Rabies vaccine was produced by Butantan for many years, using basic Pasteur process and using suckling mice to isolate brains [48][49]. The rabies virus inactivation used an ultraviolet lamp.…”

Section: Rabies Vaccine For Human Usementioning

confidence: 99%

Developing Countries Can Innovate and Produce Vaccines: The Case of Butantan in Brazil

Raw¹

2019

Vaccines - The History and Future

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Since the introduction of vaccines, governments learn that they are the most efficient and inexpensive tool to avoid the spreading of infectious diseases. It resulted in the creation of public research institutes to develop new vaccines, which gave birth to the vaccine industry, that is, growing in size by acquisition of competitors, which estimate that in 2019 they will sell $58 billion, where developing countries represent 80% of the world population, submitted to be dependent of production and prices from large producers. Incapable or not willing to assume the responsibility to produce, accept to purchase vaccines in bulk for filling and labeling as "producers." Butantan, a public not for profit institute became the first producer of specific anti-venoms and anti-rabies sera. In 1985, Butantan Center of Biotechnology attracted 25 young PhD, which accepted to carry on inovations and technical developments, setting dedicated plants to produce vaccines at affordable cost, aiming self-sufficiency to distribute free through the Ministry of Health. This chapter describes problems and solutions that must be faced to produce vaccine at a cost that developing countries can afford. Keywords: vacines control epidemics, developing coutries 80% of world population, developing countries self-sufficiency, Butantan from innovation to production, anti-venonms and anti-toxinas, encloses production plants, pertussis reduction by DTP vaccine, whole pertussis low in LPS, MPLA from B pertusis as adjuvant, MPLA adjuvant reduce ¼ influenza doses an price of vaccine, vitamines A,D,E, riboflavin as adjuvants, pneumococcus-PSAP3 reduce cost of pneumo vaccine, plasma fractions not for sale, lung surfactant saves neonatals 1. Institute Butantan-research, process development, and production 1.1 Antivenoms and antitoxins Antisnake venoms were the strength of Instituto Butantan and its priority [1-4]. At the New York World Fair, Vital Brazil saved the life of an employee of the Bronx Zoo bitten by a rattlesnake, which induced President Theodore Roosevelt pay a visit to Butantan in 1915. In 1983, Butantan sera production situation was scary: venoms were collected from snakes and administered to horses. The horses were bled and their blood collected in rusted milk drums, precipitated Vaccines-The History and Future 2 with ammonium sulfate, concentrated using a dirty towel, diluted and kept in large bottles until they "mature," and covered with mold! Probable other developing countries producers used the same ancient manufacturing process. Changing the production technology was the first goal of a recent Ph.D. group of researchers supported by the staff from the production laboratories under my supervision (Figures 1-6). The first idea was to replicate the milk industry profile, creating a "hands-off " fully enclosed system using large stainless steel tanks and an industrial plate centrifuge. After snake venom inoculation, horse blood was collected in a 7-liter sterile bag with anticlotting solution, stirred, and kept in a cold room overnight. ...

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“…As a result, this is significant for the efficacy of the vaccine and side effects. Currently, the side effects linked to the vaccine are less severe and very rare, varying according to the origin of the vaccine (18)(19)(20)(21)(22).…”

Section: Introductionmentioning

confidence: 99%

Assessment of Emergency Service Attendance Due to Rabies Suspect Animal Bites in the Van Region

Varışlı¹,

Yıldırım²,

Çelik³

et al. 2019

Eurasian J Emerg Med

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Aim:Rabies is a zoonotic viral disease transmitted by the bite of an animal. In Turkey, 100,000 individuals are administered prophylaxis annually after contact with animals carrying the risk of rabies. In this study, we investigated compliance with treatment and the affecting factors. Materials and Methods:The study assessed data from a total of 813 patients with potential animal bites throughout the year 2013. Results:The mean age of participants in the study was 22.6±16.8 years, and 80.6% (n=655) were male. Participants of both sexes mainly attended in the spring and summer months; however, it was identified that the rate of women attending in winter was higher than men. Also, five doses of vaccination were ordered for nearly all patients, independent of immunoglobulin administration; however, the rate of patients completing all five doses remained at about 30%.Conclusion: Increasing awareness of rabies will aid in the control of the significant public health problem of potential bite cases. As the young population is at risk, it is necessary to take precautions for the childhood age group.

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Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium

Cited by 13 publications

References 17 publications

Estratégias de campo em ensaios clínicos com novas vacinas produzidas no Brasil

Estratégias de campo em ensaios clínicos com novas vacinas produzidas no Brasil

Developing Countries Can Innovate and Produce Vaccines: The Case of Butantan in Brazil

Assessment of Emergency Service Attendance Due to Rabies Suspect Animal Bites in the Van Region

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