The live attenuated VLA1553 virus vaccine candidate for active immunization and prevention of chikungunya virus disease has shown immunogenicity and safety 180 days post-dose, according to a phase III trial published in the journal The Lancet.
Chikungunya is a mosquito-borne viral disease endemic to parts of tropical countries in Africa, Southeast Asia, the Indian subcontinent, the Pacific region, and introduced to the Americas in 2013, with sporadic and unpredictable outbreaks that have caused at least five million chikungunya virus infections in the past 15 years in more than hundred countries, which highlights it as a threat to global health. there is a urgent medical need for infection prophylaxis by the chikungunya virus, since no specific treatment or vaccine is available.
The non-contagious disease is transmitted by the bite of mosquitoes of the genus Aedesmainly the species Temples of the Egyptians y Aedes albopictus (tiger mosquito), two species that are active during the day and also transmit other viruses such as dengue and Zika.
In 2004, the transmission of chikungunya virus infection in Spain was confirmed for the first time through Aedes albopictus in locations close to Barcelonaand since then the mosquito has been spreading along the entire Mediterranean coast, being detected from Girona to Granadain addition to the Balearic Islands and the province of Guipúzcoa.
From headache to chronic arthritis
The disease currently has no specific treatment, only the symptoms that start between 3 and 7 after the bite are managed: high fever, headache, joint pain and muscle pain that may be followed by a skin rash, which can last for months or even years, depending on the patient.
Previous studies have shown persistent disease in more than half of those infected, causing disabling chronic polyarthritis. The case fatality rate is estimated to be low, around 0.3-1 per 1,000, with most reported deaths in neonates, chronically ill or immunocompromised adults, and the elderly.
The study has shown that this vaccine candidate triggers immune response in 99% of participants (263 of 266 people included in the study) and “generally well tolerated”.
“This may be the first chikungunya vaccine available to both people living in endemic regions and travelers,” said Martina Scheneider, Valneva’s director of clinical strategy and lead study coordinator, in a statement reproducing The Lancet, after confirming some “promising” results and stresses the “robust immune response observed in the older participants”. Although fatal in few cases, newborns and the elderly result especially vulnerable.
The trial was not carried out in regions where chikunguya is endemic, so its objective was not to directly analyze whether the preparation is capable of protecting the community against infections with the virus.
The trial on the safety of the preparation involved 4,115 adults, of whom 3,082 received a dose of the vaccine and 1,033 placebo, while the induced immunity was analyzed in 362 participants, of whom 266 received the vaccine and 96 placebo.
Among people given a dose of VLA1553, the most common adverse effects were headache (in 32% of cases), fatigue (29%), muscle pain (24%), joint pain (18% ) and pain at the puncture site (13%). “Serious adverse events” were reported in 2% of participants who received the vaccine (46 of 3,082), but no deaths.
“The strong immune response and the generation of seroprotective titers in almost all vaccinated participants suggest that VLA1553 is an excellent candidate for the prevention of disease caused by chikungunya virus,” the study concludes.
2023-06-13 10:11:18
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