It is for people over 60 years of age; starting Monday, the tests will be performed at the Central Military Hospital.
Next week, the study of one of the two vaccines tested so far against a respiratory virus more dangerous than influenza in this population will start next week in the country with volunteers over 60 years of age. Of these two developments currently underway, and which will be running in parallel as of Monday at the Central Military Hospitalthe one from the North American laboratory Moderna is the first one against the respiratory syncytial virus (RSV) with mRNA platformas that of the doses for Covid-19 which are being applied as boosters in the country.
"A person with RSV lung disease is 200 times more likely to have a heart attack within a week of the disease settling in the lungs," he points out from published data Gonzalo Pérez MarcGonzalo Perez Marc, principal investigator of the phase 3 versus placebo clinical trial that will be recruiting volunteers during this month. "At one year," he continues, "mortality also increases in these patients."
In those over 60 years of age, he continues, if the infection transforms into viral pneumonia, as occurs with the virus that causes Covid, epidemiological data on the impact of RSV in the countries that report them indicate that mortality may exceed that attributed to influenza.. "The virus can damage the lung, worsen underlying diseases or increase the risk of co-infection by contracting other bacterial respiratory infections," adds Perez Marc about a virus that is little talked about in adults and can cause more than a cold in the cold season.
There are centers where older adults are being prescribed a respiratory pathogen test (viral panel) that includes RSV, which is best known for being responsible for bronchiolitis in children.
Two years
The study, which is expected to last two years and will allow the efficacy of the vaccine, called mRNA-1345, to be determined. called mRNA-1345will involve between 1,000 and 3,000 volunteerswho can be enrolled here. The requirements are be 60 years of age or older, live no more than 80 kilometers from the hospital where the study will be done and not have autoimmune diseases or type 1 diabetes or obesity. If you have any chronic disease, such as heart disease or hypertension, it must be controlled.
"It is desirable that those who participate have chronic diseases because this is the population group that would benefit most from the vaccine and will be the first risk group for which it would most likely be recommended once regulatory authorities authorize its use."
The safety and antibody quality results obtained with the mRNA monodose in phase 2 (not yet published) enabled to advance to the next stage in a group of volunteers. While the virus is circulating, once the dose is applied, it will be recorded how many infections occur in those who are vaccinated and those who are not (placebo) and how many develop a severe form of the disease in each group.
"A vaccine for RSV is more difficult to obtain because it is a more complex respiratory virus than others," says Pérez Marc. That obstacle lies in obtaining the best proteins of the virus to incorporate in the vaccine and achieve an adequate response with antibodies. "The vaccine to be tested acts against the protein with which the virus will adhere to the cell it will infect once inside the organism. The immune response achieved with that [prefusion] protein is more stable than the one obtained with a postfusion one because it allows it to be much more similar to the one that would be provoked by the virus," adds the researcher.
It is expected that RSV circulation in the community will begin to decline in the coming weeks, but the team's ongoing monitoring week after epidemiological week indicates that this period could be prolonged. If so, volunteer recruitment would be extended. "If the future is to move to a MMR vaccine, which combines doses for Covid-19, influenza, and RSV, it should be from the same platform", says Perez Marc.
Covid mRNA vaccines are already available and a flu vaccine with the same platform is being tested. At the Central Military Hospital, the same team is in charge of two clinical trials with an RSV vaccine of another platform (recombinant protein) from the laboratory Pfizer in pregnant women and in 6,000 volunteers over 60 years of age, together with a third clinical trial of Moderna's mRNA vaccine against influenza in people over 18 years of age.
By Fabiola Czubaj-La Nación
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