ViveBio and Butantan Institute Enter into a Collaboration Agreement for Research in Sample Stabilization Technology to Support Phase III Dengue Vaccine Studies
ALPHARETTA, Ga., March 14, 2016 /PRNewswire/ -- ViveBio, a leader in biological specimen stabilization technologies, announced today it has signed a Collaboration Agreement with the Butantan Institute of Sao Paolo, Brazil to support clinical research related to their Phase III study of a live attenuated tetravalent dengue vaccine.1 ViveST technology will be used to collect and ship specimens in a dried shelf stable format throughout 14 clinical sites in Brazil. The Institute will study the efficacy of using ViveST as an alternative to traditional specimen collection and transport using cold chain logistics. Both frozen and ViveST stabilized specimens will then be tested for the presence of dengue virus RNA using the CDC RT-PCR assay. A dried specimen stabilization technology would be advantageous in Brazil to support a scenario where wide vaccination coverage and monitoring is required in the public health system.
"As a leader in sample stabilization technology we are pleased to collaborate with the highly respected Butantan Institute of Brazil. We believe this collaboration will help further support the use of ViveST technology and fulfills our mission to make healthcare accessible to regions where it was previously unavailable," said Timothy W. Murray, President of ViveBio, LLC. "Brazil is facing an unprecedented health crisis due to the combination of vector borne viral infections of dengue, chikungunya and now the Zika. The ViveBio sample collection and transport products are uniquely positioned to aid in the response to this crisis," added Murray. Last year the Brazilian Ministry of Health declared a "dengue fever epidemic", with over 1.4 million Brazilian citizens reportedly sickened by the virus.2 Already in 2016 the MoH reported 74,000 probable cases of Dengue for the period of January 3 to January 23, 2016.3 This is a 50% increase from the same period in 2015.
The Butantan Institute is a non-profit producer of immunobiologic products in Brazil and licensed the TV003 vaccine from the NIH - National Institute of Allergy and Infectious Diseases (NIAID). The Institute is sponsoring the placebo-controlled, multi-center Phase 3 trial using test vaccine produced in Sao Paulo.4 The goal of the trial is to determine if the candidate vaccine prevents dengue fever and to provide additional information about its safety. The study is scheduled to be conducted over 5 years and aims to enroll almost 17,000 healthy people. The investigators hope to have early indications of the potential efficacy of the vaccine in less than two years.
"Sending samples from remote areas to reference laboratories is needed to establish accurate surveillance of infectious diseases. ViveST appears to provide a solution to solve this issue and we will assess it in the field during our phase III dengue vaccine clinical," said Dr. Marcelo De Franco, Deputy Director of Butantan Institute.
About ViveBio, LLC.
ViveBio, LLC is a biotechnology company focused on providing high quality yet cost-effective solutions for specimen transportation, storage and blood component separation, along with cutting edge clinical diagnostics. ViveBio's mission is to expand access to healthcare and extend life through these cost effective solutions and other breakthrough technologies. The company's manufacturing and corporate office are located in Alpharetta, Georgia. For more information regarding ViveST and recent scientific publications and posters, please visit the ViveBio website at www.vivebio.com. Company Contact: Brad Nelson, Investor Relations: [email protected] or 877-814-7004.
About Instituto Butantan
Instituto Butantan is the main producer of immunobiological products in Brazil. Butantan carries out scientific missions domestically and abroad through the Pan American Health Organization, the World Health Organization, UNICEF and the United Nations. The institute collaborates with other agencies of the São Paulo State Secretariat of Health and the Brazilian Ministry of Health for the improvement of overall health in Brazil. It acts in partnership with various universities and entities such as the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation for the achievement of its institutional objectives. For more information please visit the Institute website at www.butantan.gov.br or contact the press office at (+55 11) 2627-9606 / 9428 or email to [email protected]
1Precioso AR, Palacios R, Thomé B, et al. Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine. Vaccine 2015;33(50):7121-5.
2Secretaria de Vigilância em Saúde − Ministério da Saúde. Epidemiological Bulletin - Volume 46 - No. 24-2015 - Monitoring of cases of dengue fever and chikungunya. Epidemiological Week 36, 2015. Available at: http://portalsaude.saude.gov.br/images/pdf/2015/outubro/15/svsbe-denchikzik-v46-n31.pdf - Accessed 21 October 2015.
3Secretaria de Vigilância em Saúde − Ministério da Saúde. Epidemiological Bulletin - Volume 47 - No. 6-2016 - Monitoring of cases of dengue, chikungunya fever and fever by Zika virus through Week Epidemiologic 3 , 2016. http://combateaedes.saude.gov.br/images/pdf/2016-004-Dengue-SE3.pdf
4https://clinicaltrials.gov/ct2/show/NCT02406729
SOURCE ViveBio, LLC
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