GlaxoSmithKline (GSK) has commenced the dosing of patients in a Phase III clinical programme, AReSVi, of its Respiratory Syncytial Virus (RSV) candidate vaccine for older adults.

The RSV candidate vaccine has a recombinant subunit pre-fusion RSV antigen (RSVPreF3) along with the company’s proprietary AS01 adjuvant.

The latest study follows positive Phase I/II safety, reactogenicity and immunogenicity results of the candidate vaccine.

The Phase III clinical programme has two studies: AReSVi 004 and AReSVi 006.
AReSVi 004 is a randomised, open-label study, which will enrol up to 1650 adult participants.

It will assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to three years on administering the RSV candidate vaccine in participants aged 60 years and above.

GSK anticipates reporting interim results in the second half of next year, while the study is likely to be concluded in early 2024.

AReSVi 006 study, which will analyse the efficacy of the candidate vaccine in providing protection to older adults against lower-respiratory tract disease linked to RSV, will be initiated soon.

The company noted that the Phase III programme for the RSV candidate vaccine for older adults will enrol a total of over 10,000 participants, as is standard for late-stage clinical trials where correlate of protection is yet to be established.

GSK R&D Vaccines head and senior vice-president Emmanuel Hanon said: “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.

“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.”

Last November, the company initiated dosing of patients in the Phase III clinical programme evaluating the safety and efficacy of its RSV candidate vaccine for maternal immunisation (GSK3888550A).