French Manufacturer Releases Promising Phase 3 Clinical Trial Results for Chikungunya Vaccine: VLA1553

The French manufacturer of a vaccine for SARS-CoV-2, which induces Covid-19, which is marketed in Spain, has just released the results of the first phase 3 clinical trial of a candidate preparation for the chikungunya virus. This pathogen is endemic in some countries in Africa, Asia and Latin America. The future vaccine is, according to what they say, safe and provokes an immune response.

The Valneva gala company, in a clear strategy marketiniana facing its shareholders, has made public the results of a study that disseminates The Lancetwhile announcing that “his senior management attended the Jefferies Healthcare Conference, in New York, and will also participate in the Annual Global Healthcare Conference organized by Goldman Sachs, in Dana Point (California), the next June 12-15, and to the Stifel European Healthcare Conference, in Bordeaux (France), between June 28 and 30”.

Among the conclusions of this study, whose main author is Dr. Martina Schneider, Clinical Strategy Manager at Valneva, it is said that a single dose of the vaccine candidate VLA1553 is generally safe, well tolerated and provokes an immune response against the chikungunya virus; produced levels of neutralizing antibodies that are believed to protect against disease in 99% (263/266) of the volunteers; antibody levels declined 28 days after vaccination, but seroprotection persisted in more than 96% (233/242) of participants after six months.

Also, the authors point out that most adverse events were moderate or mild and that its safety profile is similar to that of other licensed vaccines.

First vaccine against chikungunya virus

The researchers point out some limitations. The study was not carried out in an endemic region, so participants’ pre-existing immunity to chikungunya virus is unknownas well as the safety of the preparation in this population.

Also, the vaccine was made with a weakened version of the live virusso it may not be suitable for people with weakened immune systems and pregnant women.

They also recognize that, to be highly effective in endemic disease control, they also children will need to be vaccinated against chikungunya. To determine safety and efficacy in this age group, a study is currently being conducted in adolescents in endemic areas of Brazil.

Currently, there are no approved vaccines to prevent the disease. caused by infection with this pathogen, nor are there effective antiviral treatments for the disease.

Dr. Schneider recalls that since age is a risk factor for the severity and mortality of chikungunya disease, the strong immune response observed in older participants in her study “could be especially beneficial.”

The study involved a total of 4,115 healthy adults at 43 sites in the United States. Of this number, 3,082 received a dose of the vaccine candidate and 1,033 a harmless substance (placebo).

All participants were included in the safety analysis, but the immune response was only tested in a subgroup of 362 participants (266 received the vaccine and 96 received placebo).

The study authors assessed the participants’ immune responses one week, 28 days, three months and six months after vaccination. They also recorded adverse events in an electronic diary for 11 days after vaccination.

Protects against disease by 99%

Those who experienced adverse events within 21 days of vaccination (for example, fever and joint pain, back pain, neurological symptoms, heart problems, rash or swelling) were monitored more closely.

After a single vaccination, VLA1553 induced antibody levels at a level considered protective against disease in 99% (263/266) of participants. There was no difference in the immune response according to age.

In general, the preparation -always according to these scientists- was well tolerated in all age groups and most adverse events were mild or moderate. Among those who received the vaccine, the most common adverse events were headache (32% of those vaccinated), fatigue (29%), muscle pain (24%), joint pain (18%), and pain at the site of injection (13%).

Serious adverse events were reported in 2% (46/3082) of participants exposed to VLA1553 and in 1% of participants in the placebo arm (8/1033). Two of these were related to the vaccine. One was a case of mild muscle pain in a woman with a medical history of fibromyalgia, and the other was a fever that led to hospitalization. None of these cases resulted in death.

Aedes mosquitoes and Chikungunya disease

Chikungunya virus is a mosquito-borne disease Aedes widely distributed in tropical regions of Africa, Southeast Asia, the Indian subcontinent, the Pacific region and introduced to the Americas since 2013.

The disease is transmitted by mosquito bites. Aedesmainly Aedes aegypti y Aedes albopictus (tiger mosquito), two species active during the day and that also transmit other viruses such as Dengue and Zika.

The treatment of this disease is symptomatic and it is not contagious, that is, it is not transmitted from person to person.

From the Community of Madrid, they recommend that the best way to prevent the disease is to avoid mosquito bitesfollowing these recommendations:

• Put mosquito nets on the windows and doors, to prevent the entry of the insect.
• Apply electrical anti-mosquito diffusers to the plugs in the rooms.
• It is advisable to wear protective clothing, long-sleeved shirts and long pants.
• Do not accumulate water in the surroundings of the home where the mosquito can nest (potted dishes, puddles, watering cans, etc.).
• Commonly used insecticide and mosquito sprays can be applied once a day in rooms and bedrooms.
• If possible, put fans or air conditioning to make it difficult for mosquitoes to enter the rooms.
• Use repellent products for personal use. The repellents indicated are those in common use and are for sale in pharmacies and drugstores:

• • • • DEET (N,N-Diethyl-meta-toluamide)
      • Icaridin
      • IR3535 (ethyl-butyl-acetylaminopropionate). Recommended for pediatric use.