Respiratory syncytial virus (RSV) vaccine! Adjuvant RSVPreF3 OA vaccine critical phase 3 clinical trial: reduced severe disease by 94.1%, overall vaccine efficacy 82.6%!

Adjuvant RSVPreF3 OA vaccine: overall vaccine efficacy 82.
6%, efficacy against severe disease of RSV-LRTD 94.
1%, efficacy of 93.
8% in the elderly population aged 70-79 years, efficacy of 94.
6%
in people with underlying comorbidities.

October 20, 2022 /BioValleyBIOON/ -- GlaxoSmithKline (GSK) has announced positive results
for AReSVi-006, a pivotal Phase 3 clinical trial of an older adult (OA) vaccine candidate.
This is a randomized, placebo-controlled, observer-blinded, multi-country phase 3 trial to evaluate the effectiveness
of a single-dose adjuvant RSVPreF3 OA vaccine candidate in older adults aged 60 years and older.
The trial enrolled approximately 25,000 participants
from 17 countries.

The results showed that the trial met the primary endpoint: the adjuvant RSVPreF3 OA vaccine candidate was highly effective in the elderly population aged 60 years and older, with an overall vaccine efficacy of 82.
6% (96.
95% CI: 57.
9-94.
1; 7 out of 12,466 versus 40 out of 12,494).

In addition, consistently high vaccine efficacy was observed across a range of prespecified secondary endpoints, highlighting the impact
that the adjuvant RSVPreF3 OA vaccine candidate may have on populations most at risk of serious consequences from RSV.
The vaccine efficacy of the adjuvant RSVPreF3 OA vaccine candidate for the prevention of severe RSV-LRTD was 94.
1% (95% CI: 62.
4 to 99.
9; 1 in 12,466 versus 17
of 12,494).
Severe RSV-LRTD is defined as LRTD with at least 2 lower respiratory symptoms or assessed by the investigator as severe
.

Among participants with comorbidities (e.
g.
, underlying cardiopulmonary and endocrine metabolic diseases), vaccine efficacy was 94.
6% (95% CI: 65.
9 to 99.
9; 1 of 4937 versus 18 of 4861); In the elderly population aged 70 to 79 years, the observed vaccine efficacy was 93.
8% (95% CI: 60.
2 to 99.
9; 1 in 4487 versus 16 of 4487).

In addition, the vaccine efficacy of the adjuvant RSVPreF3 OA vaccine candidate for the prevention of RSV-A and RSV-B subtypes LRTD was consistent (subtype A: 84.
6%, 2 of 12 466 versus 13 of 12 494; Subtype B: 80.
9%, 5 of 12,466 versus 26 of 12,494), consistent
with the potent neutralizing antibody response produced against these two subtypes.

In the trial, the candidate vaccine was well tolerated and had a good
safety profile.
Adverse events observed were usually mild to moderate and transient, with the most common being injection site pain, fatigue, myalgia, and headache
.

AReSVi-006 test results (Image source: GSK)

It is worth mentioning that the adjuvant RSVPreF3 OA vaccine candidate is the first RSV vaccine
to show statistical and clinical significance in the elderly population aged 60 years and older.
Based on the above Phase 3 clinical trial data, GSK expects to submit marketing application documents
for its adjuvant RSVPreF3 OA vaccine candidate in the second half of 2022.

Tony Wood, Chief Scientific Officer at GSK, said: "Despite more than 60 years of research, RSV today remains one of the major infectious diseases without a vaccine, and given this, this is truly an extraordinary result
.
We believe that as this pivotal trial demonstrates the high efficacy of the vaccine, our vaccine candidate has the potential to help reduce the significant global burden of RSV-related disease in the elderly population, including those at risk of serious consequences due to age or underlying comorbidities
.
”

RSV is a common contagious virus that affects the lungs and respiratory tract
.
It is one of
the main remaining infectious diseases for which there is currently no vaccine or special treatment.
Older adults are at high
risk of severe RSV disease due to age-related weakened immunity and underlying medical conditions.
RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to serious consequences such as pneumonia, hospitalization and death
.
Each year, RSV causes more than 360,000 hospitalizations and more than 24,000 deaths
among adults worldwide.
Adults with underlying medical conditions are more likely to seek medical advice and have higher
rates of hospitalization.

The RSVPreF3 OA vaccine candidate contains a recombinant subfusion pre-RSV F glycoprotein antigen (RSVPreF3) and is bound
to GlaxoSmithKline's proprietary AS01 adjuvant.
AS01 has been used in several of GSK's available adjuvant vaccines
.
Antigen plus adjuvant combinations may help overcome the natural decline in age-related immunity, which can help protect older adults from the challenges
of RSV disease.

AReSVi-006 is part of
GSK's comprehensive RSV evidence generation project.
The trial will continue to evaluate the annual revaccination schedule and long-term protection across multiple seasons
following a single-dose adjuvant RSVPreF3 OA vaccine candidate.
The safety of the trial is being closely monitored and the safety data will be continuously reviewed
by an internal and external independent data monitoring committee.
(Bio Valley Bioon.
com)

GSK's older adult respiratory syncytial virus (RSV) vaccine candidate shows 94.
1% reduction in severe RSV disease and overall vaccine efficacy of 82.
6% in pivotal trial