India offers a rare ray of hope for an indigenously-made vaccine against chikungunya, but delay in finding volunteers is impeding its development. With chikungunya spreading very fast in the country, researchers are seeking urgent government intervention for speedy completion of the vital clinical trials. Chikungunya is a dreaded infection transmitted through the bite of mosquito. There is no known cure and till date there is no vaccine anywhere in the world against it. For the first time, an indigenously-developed vaccine against chikungunya has been developed and the first human trials are underway albeit on a slow pace. If all goes on well, a vaccine against chikungunya could be a reality in a few years. The novel vaccine candidate against chikungunya crossed a big hurdle last year when Bharat Biotech, a Hyderabad-based vaccine pioneer, got permission to start human trials and the first human subjects received the vaccine a few months ago.
The company says the phase-I trials will “evaluate the vaccine’s safety, tolerability and immunogenicity. The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen”.
But today, the first trial of its kind of vaccine against chikungunya has literally ground to halt midway and it is getting hugely delayed, says Dr. Krishna Ella, chairman & managing director of Bharat Biotech. Ella seeks urgent intervention of the Indian Council of Medical Research and the Ministry of Health and Family Welfare to “expedite the process and to iron out the wrinkles that is hindering recruiting healthy volunteers”. Ella confirms that “only 10 per cent of the volunteers could be recruited over several months since healthy volunteers as per the notified regulation are forced to stay in a medical intensive care unit (ICU) after the intra- muscular injection is administered”.
According to Ella, this mandatory stay in an ICU scares the volunteers. Especially, since in an intensive care unit the volunteers are usually surrounded by very-very sick patients. Ella says in the US, a phase-I trial can easily be completed in about four months but in India it is taking way too long. India is not well-known for developing novel vaccines and the only indigenously-discovered and made-in-India vaccine is the one against Rota Virus which causes diarrhoea in infants. Incidentally the Rota Virus vaccine was also manufactured at Bharat Biotech and hence there is hope that the chikungunya vaccine may also reach its fruition.
This is an abysmal situation since according to the estimates by the World Health Organisation (WHO), every third child in the globe – who is vaccinated through its programme – is protected through a vaccine manufactured in India. So India does a great job in being the manufacturing hub for cheap generics but as a country it fails to promote novel vaccine development. India is ranked 60th among 130 countries on the Global Innovation Index-2017 released this week. There is an urgency since with the monsoon rains arriving, the spectre of another chikungunya outbreak looms large. Chikungunya is a highly-painful disease where the joints ache like anything and patients are literally not able to walk and at times have to crawl.
In Africa, chikungunya means “to become contorted”. The disease also causes fever and usually the symptoms last for up to two weeks but in many people, the pain in the joints can persist for months or even years. According to the Centers for Disease Control and Prevention (CDC), Atlanta, “there is no vaccine to prevent or medicine to treat chikungunya virus infection.” The WHO says there is no specific antiviral drug treatment for chikungunya. Treatment is directed primarily at relieving the joint pain using anti-pyretics, optimal analgesics and fluids. This makes it worse for the patient.
The viral disease has symptoms very similar to dengue infection except for the terrible pain in the joints. The infection is transmitted through the byte of Aedes aegypti and Aedes albopictus mosquito. The bug is also called a tiger mosquito and this pesky insect is a day biter and usually breeds in clean water inside homes in places like flower vases and desert coolers. Thanks to its breeding habits and cunning nature, it is very hard to eradicate the mosquito and hence to control the disease physicians have been asking for a suitable vaccine.
In 2016, chikungunya emerged as major outbreak especially in northern India with the country seeing an almost a three- fold jump in infections with the total touching almost 64,000. But these are only the cases that had been confirmed through a laboratory diagnosis and experts felt the actual number could be more than ten times higher. In 2017, almost 7,000 cases of chikungunya have already been reported. Chikungunya falls under the category of neglected tropical diseases and hence most big western pharmaceutical companies do not want to indulge in making a vaccine against a disease which mostly afflicts the poor.
Bharat Biotech says it developed the chikungunya vaccine it calls CHIKV using an isolate of the virus from Indian epidemic. The inactivated virus vaccine developed by the in-house R&D was found to be safe and immunogenic in pre-clinical animal testing. After successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the Drugs Controller General of India last year. According to Ella, “Chikungunya is one among the modern day most dreaded virus, and developing an efficient vaccine to prevent it means a lot to people at risk for the infection.
Our pre-clinical studies were promising and we hope that the first-in -human clinical trials successfully meets with the clinical endpoints.” Not easy, since clinical trials are not only very expensive to conduct but are also very risky since failures are common place. Ella says if Prime Minister Narendra Modi’s dream of ‘Make in India’ has to become a reality then ease of doing business should go hand in hand.