IVI, Bharat Biotech begin phase II/III clinical trial of Chikungunya vaccine

 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.

Hyderabad: The International Vaccine Institute (IVI) and Bharat Biotech on Wednesday announced the beginning of Phase II/III clinical trial of Chikungunya vaccine candidate (BBV87) in Costa Rica.

 IVI is leading the Global Chikungunya vaccine Clinical Development Program (GCCDP) consortium in partnership with Bharat Biotech and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology, India.

 IVI said it is advancing clinical development of BBV87 through a Phase II/III randomized, 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.

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According to the official release, 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 that potentially makes this vaccine accessible to special populations, such as the immunocompromised and pregnant women, that some other technologies cannot reach.

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.

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.”

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 the 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.”

 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.”

According to the official release, CEPI first partnered with IVI and Bharat Biotech International Limited in June 2020, providing up to USD 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 USD 2 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.

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