The first participant received Bharat Biotech International Ltd's (BBIL) Chikungunya vaccine candidate (BBV87) in a Phase II/III clinical trial in Costa Rica.
IVI is advancing clinical development of BBV87 through a Phase II/III randomized, controlled trial to evaluate the safety and immunogenicity of a 2-dose regimen of BBV87 Chikungunya vaccine in healthy adults at 9 clinical trial sites across 5 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.
As needed, CEPI or BBIL 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 authorization in emergency situations based on national or international guidance (such as by the WHO).
Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said: "Epidemic preparedness is a vital step in public health care. 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 realize a safe, 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."
Dr. Ella added, "Our Director of R&D, Dr. Sumathy K, Head of the Chikungunya vaccine development program, is actively involved with research and development of this vaccine and works closely with the GCCDP consortium."
Dr. Sushant Sahastrabuddhe, Acting Associate Director General at IVI and Principal Investigator of 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.
CEPI first partnered with IVI and BBIL in June 2020, providing up to US $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 US $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 subsequent manufacture of clinical trial materials.
Dr. Melanie Saville, Director of 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, globalization, 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 Prequalification for a Chikungunya vaccine and make it accessible to affected populations."
Dr. Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC), said: "Chikungunya is a severe and devitalizing 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."
About BBV87 vaccine candidate
BBIL's BBV87 vaccine is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype.
The vaccine has completed standard pre-clinical studies, and an optimum immune response was elicited by the adjuvanted vaccine in phase 1 clinical trials in India.
Inactivated virions technology has a safety profile which potentially makes this vaccine accessible to special populations, such as the immunocompromised and pregnant women, that some other technologies cannot reach.
About Chikungunya virus
Chikungunya virus was first identified in Tanzania in 1952, with sporadic outbreaks of the disease reported subsequently across Africa and Asia. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, the total number of cases has been estimated at over 3.4 million in 43 countries.
Chikungunya is spread by the bites of infected female Aedes mosquitoes and causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.
Climate change could further amplify the threat posed by Chikungunya. As the climate warms, more areas across the world will become habitable for the mosquito vectors that transmit the virus, thereby increasing the size of the human population at risk of infection.
For example, in 2007, an outbreak of Chikungunya virus infections was declared for the first time in Europe with more than 200 human cases reported in Italy Since 2014, in the USA, local transmission of the virus has been reported in Florida, Puerto Rico, Texas and the U.S. Virgin Islands.