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.