Please login to the form below

Not currently logged in

GSK launches late-stage testing of RSV vaccine candidate in older adults

Vaccine candidate was found to be well-tolerated in a phase 1/2 trial

GlaxoSmithKline (GSK) has launched a phase 3 trial investigating its respiratory syncytial virus (RSV) vaccine candidate in older adults.

In a phase 1/2 trial of GSK’s RSV vaccine candidate in both young and older adults, the jab was found to have promising safety and immunogenicity and was also well-tolerated.

The results from this study showed that, one month after immunisation, the vaccine had elicited a robust humoral and cellular immunity compared to baseline.

The vaccine also caused an almost ten times increase of RSV-A neutralising antibodies, and above a 12 times increase of RSV antigen (RSVPreF3) IgG antibodies in the vaccinated group.

According to GSK, these results show that its RSV vaccine candidate can stimulate the immune system in older adults to produce a similar level of antibodies as young adults.

RSV remains a significant health threat for older adults (over 60 years of age), with approximately 360,000 hospitalisations and 24,000 deaths associated with RSV infections each year in developed countries.

“RSV is one of the most significant remaining unmet medical needs for older adults, with one out of six infected with RSV requiring a hospitalisation,” said Emmanuel Hanon, senior vice president and head of vaccines R&D for GSK.

“With our unique combination of technologies, the pre-fusion F antigen and our proprietary adjuvant system, we were able to induce a strong immune response, of both humoral and cellular components, to levels normally seen in healthy adults,” he added.

GSK’s RSV vaccine candidate contains subunit pre-fusion RSVPreF3 combined with the company’s AS01 adjuvant, which is also used in its shingles vaccine.

GSK is developing a number of candidates within its RSV vaccine portfolio, which also includes maternal and paediatric vaccine candidates.

A phase 3 efficacy study for the maternal RSV vaccine candidate started in November 2020, while a phase 1/2 study with the paediatric RSV candidate vaccine is currently ongoing.

The three RSV vaccine candidates across the different patient populations have each received a fast-track designation from the US Food and Drug Administration (FDA), GSK said in a statement.

Article by
Lucy Parsons

17th February 2021

From: Research



PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs


Add my company
Say Communications

Influencing positive behaviours and delivering change is what drives us, using thought leadership, education, social and professional engagement and compelling,...

Latest intelligence

Looking back at the year when everything changed
COVID-19 has impacted every aspect of our lives, from the way we shop for groceries to the way we conduct work and interact with healthcare providers and our families....
Back to the future
Five years ago, an influential book used Darwin’s ideas to predict the future of the industry – how did that work out?...
Rare Disease Day 2021
To mark Rare Disease Day 2021 on Sunday 28 February, OPEN Health will be intentionally quiet on all LinkedIn channels from 26 February to 1 March in order not to...