ICMR set to collaborate with pharma companies to develop dengue vaccine

With the rise in dengue cases across the country, the Indian Council of Medical Research (ICMR) has embarked on an initiative aiming to facilitate development of dengue vaccine. Vaccine manufacturer and pharma companies who have developed or have license of tetravalent dengue vaccine candidate and have successfully completed its phase I and phase II clinical trials, can collaborate with ICMR for conducting phase III trial and subsequent development of the vaccine. The apex biomedical research institute will offer institutional infrastructure for undertaking research and development (R&D) activities and phase -III clinical trials for evaluation of efficacy along with safety and immunogenicity of tetravalent dengue vaccine candidate developed by Indian manufacturers or having license for the same. It has on March 4, 2022 invited expression of interest from the Indian manufactures who have developed potential tetravalent vaccine candidate or have non-exclusive license of the tetravalent vaccine candidates and intend to conduct field study as phase-III clinical trial after completion of phase I and phase II trial for successful development of a dengue vaccine. The collaboration with the Indian vaccine manufacturer will be on royalty basis for a fixed term contract condition for conducting phase-III clinical trials. The manufacturers/companies interested in this collaboration may offer royalty 5 per cent or above (in per cent) on net sales of the end product on half yearly basis, up to March 31 and up to September 30 respectively every year provided that the liability of the company/manufacturer to pay royalty shall accrue upon the commencement of the commercial sale of the product manufactured at the plant. ICMR would provide technical support through team of experienced scientists in study planning, development of clinical trial protocol, implementation of phase III clinical trial of tetravalent dengue vaccine, generating results/data analysis, outcome assessment, safety, immunogenicity & efficacy assessment, product improvement, and funding essential activities or others, if deemed fit upon the mutual understanding between ICMR and the collaborating company. ICMR through its institutes would provide support and facilitate the conduct of the clinical trial of developed vaccine candidate in India through one or more of its affiliates/institutes, in collaboration with company/institutions in a professional and mutually agreed-upon manner and timelines, which will be decided later under a specific agreement. The process developed by firm(s)/organization(s) during the course of development of the product encompassing IP, shall be owned jointly by ICMR and firm(s)/organization(s). The dengue virus is a mosquito-borne viral disease that is transmitted by the bite of the female mosquitoes mainly of the species Aedes aegypti and, to a lesser extent, Ae. albopictus. It belongs to the Genus Flavivirus and consists of four serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Recovery from infection by one of the serotypes provides lifelong immunity against that particular serotype. However, cross-immunity to the other serotypes after recovery is only partial and temporary. Subsequent infections by other serotypes increase the risk of developing severe dengue. The clinical manifestations of dengue range from asymptomatic cases to flu-like illnesses to severe dengue occurring as a result of plasma leakage resulting in fluid accumulation, respiratory distress, severe bleeding, or even organ impairment. The actual numbers of dengue cases are underreported and many cases are misclassified. However, the incidence of dengue has grown dramatically around the world in recent decades with extension of the disease to pediatric population. A recent estimate indicates an occurrence of 390 million dengue infections per year, of which 96 million manifests clinically (with any severity of disease). Hence, the World Health Organization has identified dengue to be one among the top ten global health threats in 2019. In India, the dengue sero-prevalence survey conducted from June 2017 to April 2018, revealed that the overall seroprevalence of DENV infection in India was 48

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!