Chikungunya vaccine candidate enters Phase 2/3 trial

By Rachel Arthur contact

- Last updated on GMT

Pic:getty/doug4537
Pic:getty/doug4537

Related tags: Bharat Biotech, Chikungunya, Vaccines

The International Vaccine Institute (IVI) and Bharat Biotech have started a Phase 2/3 clinical trial for a chikungunya vaccine candidate in Costa Rica.

The inactivated whole virion vaccine, BBV87, has entered the randomized, controlled trial to evaluate the safety and immunogenicity of a two-dose regimen in healthy adults.

The trial is starting at Clinica San Agustin in Costa Rica, and will expand next month to Panama and Colombia followed shortly afterwards by Thailand and Guatemala.

Goals for an affordable vaccine

There are currently no preventative vaccines or effective treatments available for chikungunya.

While the virus was first identified in Tanzania in 1952, it begun to spread quickly in 2004 with large-scale outbreaks around the word. Since the re-emergence of the virus, there have been an estimated 3.4 million cases in 43 countries.

Climate change could further increase the threat posed by chikungunya: as the climate warms, more areas of the world will become home to the infected female Aedes mosquitos which transmit the virus. An outbreak was declared in Europe for the first time in 2007 and local transmission has been reported in the US since 2014.

Around one billion people in the world are already estimated to be at risk from chikungunya infection.

The Global Chikungunya vaccine Clinical Development Program (GCCDP) aims 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.

The GCCDP consortium

The IVI is leading efforts under the Global Chikungunya vaccine Clinical Development Program (GCCDP) consortium in partnership with Bharat Biotech International Ltd.; with support from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Government of India’s epidemic preparedness initiative, Ind-CEPI.

CEPI partnered with IVI & BBIL in June 2020, providing up to $14.1m for manufacturing & clinical development of BBV87. This is supported by the EU's Horizon 2020 programme through an existing framework partnership agreement with CEPI.

The Ind-CEPI initiative has pledged up to $2m to set-up GMP manufacturing facilities for the vaccine in India and manufacture of clinical trial materials. 

Bharat Biotech’s BBV87 vaccine is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype.

Phase 1 studies in India showed an ‘optimum immune response’ was elicited by the adjuvanted vaccine.

Furthermore, the company says the tech has a safety profile which could make the vaccine accessible to special populations, such as the immunocompromised and pregnant women, that some other technologies cannot reach.

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.”

Developing a chikungunya vaccine

Fellow vaccine company Valneva estimates the global market for vaccines against chikungunya will be worth more than $500m annually by 2023.

It currently has a chikungunya vaccine candidate in Phase 3 trials. Earlier this month it announced positive Phase 3 results​ for the single-shot vaccine. Final trial results are expected in the next six months, once the trial has reached a final analysis including six months of safety data.

The vaccine has been awarded Breakthrough Designation and Fast Track status by the US Food and Drug Administration (FDA); alongside Prime designation from the European Medicines Agency (EMA).

Elsewhere, the University of Oxford has been developing a vaccine based on the ChAdOx1-vectored vaccine platform used for the COVID-19 vaccine. It published Phase 1 data for ChAdOx1 Chik last month, showing a single-dose induced neutralising antibodies against 4 chikungunya virus lineages.

Meanwhile, MV-CHIK is a vaccine candidate using Themis’ measles vector platform, consisting of recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. The vaccine is in a Phase 2 study.

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