IVI is advancing clinical development of BBV87 through a phase-II/III randomised, controlled trial to evaluate the safety and immunogenicity of a two-dose regimen of BBV87 chikungunya vaccine in healthy adults at nine clinical trial sites across five countries with endemic chikungunya. In addition to the trial at Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 2021 and in Thailand and Guatemala soon after, Bharat Biotech said in a statement.
The Global Chikungunya Vaccine Clinical Development Programme (GCCDP) seeks to develop and manufacture an affordable chikungunya vaccine with the aim of achieving WHO prequalification to enable its distribution in low- and middle-income countries, consistent with CEPI’s core commitment to equitable access, affordability and sustainability. As needed, CEPI or Bharat Biotech may propose a third-party for manufacturing of a stockpile of investigational product to be used for further clinical trials in outbreak conditions to advance vaccine development, or pursuant to an emergency use authorisation (EUA) in emergency situations based on national or international guidance (such as by the WHO).
Informing that epidemic preparedness is a vital step in public healthcare, Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Bharat Biotech’s vaccine candidate is an ingenious, well-researched vaccine, and we thank the first volunteer from Costa Rica for participating in this study. The IVI-led multi-country scale human trial has begun an important trial phase in furthering the evaluation of safety and immunogenicity. As a partner, we are committed towards GCCDP’s effort to realise a safe and efficacious vaccine that can help reduce chikungunya disease burden world over.”
“As a leader in pandemic vaccines, we have demonstrated unwavering commitment in solving the chikungunya, pandemic flu, zika and typhoid problems, as well as our relentless dedication to solve public health challenges through research and development of novel vaccines,” Ella added.
Adding to it, Dr Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC), said, “Chikungunya is a severe and devitalising disease. Taking into cognizance the need to develop an effective vaccine for chikungunya, the Department of Biotechnology, Government of India has provided financial support under the Ind-CEPI Mission, to Bharat Biotech for the Global Chikungunya Vaccine Clinical Development Program (GCCDP). It is very encouraging to witness the commencement of phase-II/III study of BBV87 in Costa Rica. This milestone is a first step towards developing a promising vaccine candidate against Chikungunya, an exhausting disease.”
Dr Sushant Sahastrabuddhe, Acting Associate Director General, IVI and Principal Investigator, GCCDP, said, “We are thrilled to announce that the first participant was dosed with BBIL’s chikungunya vaccine candidate in a multi-country phase-II/III study. The start of this trial in Costa Rica is a significant milestone in the effort to make available a safe, effective and affordable chikungunya vaccine for the one billion people around the world at risk of chikungunya virus infection. We are grateful to our partner Bharat Biotech, our clinical trial site collaborators and partners, and CEPI for this collective effort that will generate crucial safety and immunogenicity data in regions most affected by chikungunya.”
Today’s announcement furthers CEPI’s US $3.5bn plan, launched in March 2021, to tackle future epidemics and pandemics, which includes advancing vaccine candidates against known high-risk pathogens such as chikungunya.
The statement added that CEPI first partnered with IVI and Bharat Biotech in June 2020, providing up to $14.1 million for vaccine manufacturing and clinical development of the BBV87 vaccine candidate. The funding is supported by the European Union’s (EU’s) Horizon 2020 programme through an existing framework partnership agreement with CEPI. The consortium was also supported with a grant of up to $2.0 million from the Indian Government’s Ind-CEPI initiative to fund the set-up of GMP-manufacturing facilities for the vaccine in India and the subsequent manufacturing of clinical-trial materials.
Dr Melanie Saville, Director, Vaccine R&D, CEPI, said, “Chikungunya is a debilitating illness that results in substantial health and economic consequences around the world, including in low- and middle-income countries. Our modern ways of living, globalisation, vector adaptation and climate change could also threaten to advance the spread of the disease further, putting more of the global population at risk.”
“This phase-II/III study by IVI and BBIL in Costa Rica and other countries in the near future, strengthens efforts to bring an end to this public health crisis. This truly global partnership will provide critical data to inform further clinical development of the vaccine, with the hopes of meeting CEPI’s goal to develop, license and gain WHO pre-qualification for a chikungunya vaccine and make it accessible to affected populations,” Saville said.