A vaccine against the virus that heavily affects the elderly and children, especially the youngest ones. The British pharmaceutical company GSK has announced it, forecasting the positive results of a provisional efficacy analysis of the phase III study (AReSVi006) against respiratory syncytial virus.
The interim analysis was reviewed by an independent data monitoring committee and the primary endpoint was passed with no unexpected safety concerns observed. The research in question studies a vaccine against respiratory syncytial virus (RSV), but with reference to adults over 60.
A shield against the respiratory syncytial virus
by Mara Magistroni
The presentation
The results of this phase III work will be presented in a peer-reviewed publication and at an upcoming scientific meeting. Meanwhile, the study will continue to evaluate both an annual revaccination program and long-term protection over multiple seasons after taking a dose of the candidate RSV elderly vaccine. Hal BarronChief Scientific Officer and President, R&D, GSK, said, “The data obtained suggests that our vaccine candidate RSV offers exceptional protection for the elderly from the severe consequences of infection. RSV remains one of the few major infectious diseases. vaccine-free and these data have the potential to have a significant impact on treatment. They can reduce hospitalizations and deaths. And, given the importance of this data, we plan to engage immediately with regulatory authorities to anticipate approval requests in the second half of the year. 2022 “.
Syncytial virus, vaccinate the mother to protect the newborn
by Letizia Gabaglio
What does the vaccine contain
But how is the incoming vaccine composed? The drug RSV OA contains a recombinant RSV F-subunit prefusion glycoprotein antigen RSVPreF3) combined with GSK’s proprietary AS01 adjuvant.
AS01 is used for many of GSK’s already established adjuvanted vaccines. And it is precisely the most adjuvant antigen combination that can help overcome the natural age-related decline in immunity that contributes to the challenge of protecting the elderly from RSV disease.
I study
This is a randomized, placebo-controlled, blinded, multi-country phase III study that aims to demonstrate the efficacy of a single dose of the investigational vaccine in adults 60 years of age or older. And for the occasion, about 25,000 participants from 17 countries were registered.
The work examined the immunogenicity, safety, reactogenicity and persistence of the vaccine in the elderly. And it was found that in the over 60s a dose of the drug induced strong humoral and cellular immune responses, which remain above pre-vaccination levels for a period of at least six months.
Syncytial virus, one hundred thousand children under five died in 2019
Identkit del virus
Respiratory syncytial virus is contagious and common: it affects the lungs and airways. In adults, RSV causes over 360,000 hospitalizations and 24,000 deaths globally each year. However, it is one of the main infectious diseases left for which, in fact, there is no specific vaccine or treatment. The elderly are at high risk of serious diseases because, due to their advanced age, immunity decreases in them.
In addition, RSV can aggravate conditions, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure, and can lead to serious outcomes, such as pneumonia, hospitalization and death.