The Zika virus has recently been identified as the cause of a serious epidemic in Latin America and the Caribbean. Concern over the possibility of an international pandemic has led to a multi-national, and multi-lingual effort to develop the first candidate Zika virus vaccine to be approved for human clinical trials. As a result, translation services for clinical research must be provided across many languages.
When global epidemics hit, it is imperative for the best minds from all over the world to come together and come up with solutions. Such instances result in the need for international collaboration on clinical trials. Working across boundaries will require sophisticated knowledge of the disease, as well as translation services for clinical research. This is exactly the situation occurring with the current effort to push forward Zika virus clinical trials.
Zika Virus | Where is Zika From?
The word Zika literally means overgrown in Luganda – one of the major languages of Buganda, a sub-national kingdom in Uganda. It is the name given to the Zika Forest, also known as Ziika, located near Entebbe, Uganda. This is the place where the Zika virus was first identified.
First linked to infection in humans in Africa, the virus was originally not associated with the same symptoms reported in patients in the current epidemic.
A member of the Flavivirus family, which also includes Yellow Fever, Dengue and West Nile virus, Zika virus is transmitted to humans by the Aedes aegypti mosquito. Recent spreading of the virus, especially in South America, Central America and the Caribbean islands, has caused great concern over its association with microcephaly birth defects among children born to mothers who are infected during pregnancy. To date, there is no vaccine treatment.
As of May 2016, fifty-eight countries and territories had reported cases of mosquito-borne transmission of Zika Virus. Most recently, the virus has been found in mosquitoes in Miami, Florida, resulting in possible CDC travel advisory for pregnant women to parts of Miami.
Several research organizations and companies have been working on a Zika virus vaccine, including the National Institute of Health (NIH), the French company Sanofi and the Indian company Bharat Biotech. Two other firms have made progress in moving a potential cure out of development, and into testing stages. Inovio, an immunotherapy company, and the Korean-based biotech firm GeneOne, a contract manufacturer of DNA plasmid-based agents, worked together to produce their own Zika virus vaccine.
Experts originally predicted a 2018 timeline for the development of an effective vaccine. But Inovio’s-GeneOne’s candidate vaccine is already preparing for clinical trials. The two companies recently received approval to start Phase I human clinical trials. According to Inovio’s president and CEO, Dr. Joseph Kim, this fast pace is due to the unique nature of the DNA vaccine which does not require the same length of time needed to grow live virus vaccines. Both companies also agreed to scale up production prior to the completion of animal studies which ultimately worked in their favor.
Zika Virus | Eliminating Language Barriers
The globalization of the biotech industry is clearly evident in the successful collaborative efforts of these two companies in developing a Zika virus vaccine, and in their obtaining clinical trial approval for the Zika vaccine. They have previous experience working together in the development of Ebola and MERS vaccines, and once again they formed a mutually beneficial partnership, each contributing their technological strengths and moving across all language barriers. Their success is proof that linguistic differences, including Korean into English translation (and visa versa), for production protocols, clinical trial regulatory documents and legal document translation is not an issue if it is properly addressed.
Enrollment will begin soon for the Inovio-GeneOne synthetic DNA plasmid vaccine. Phase I trials will be conducted on 40 patients at sites in Philadelphia, Miami and Canada. In the future, if we are to successfully eradicate infectious diseases, it will require global cooperation. Communication across borders will be key, and high-quality life sciences translation services for clinical research are a must.
Note: This past week NIH launched its first clinical trial of Zika vaccine to be tested in 80 healthy volunteers, ages 18 to 35, at three locations: the NIH Clinical Center in Bethesda, Md.; Emory University in Atlanta; and the University of Maryland in Baltimore. The first two subjects were injected with the vaccine one month ahead of the scheduled date for initiation.
- Technology Review Zika Vaccine Testing
- Medscape View Article Zika Virus
- Clinical Trials.gov
- NIH begins first clinical trial of experimental zika vaccine
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