Vaccine Info

GSK RSV OA Vaccine

Authored by
Staff
Last reviewed
June 11, 2022
Fact checked by
Robert Carlson, MD
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GSK's RSV OA (RSVPreF3) Vaccine Description for 2022

GSK plc RSV OA vaccine candidate contains a recombinant subunit pre-fusion RSV antigen (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant. GSK’s vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant. The antigen plus adjuvant combination may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting older adults from RSV disease.

GSK’s RSV Older Adult (OA) vaccine candidate contains Agenus’ proprietary QS-21 STIMULON™ within its AS01 adjuvant, which has already demonstrated positive immune responses as well as a favorable safety profile. QS-21 Stimulon improves a vaccine’s effectiveness by inducing strong antibody and cell-mediated immune responses. It also plays a key role in boosting immune response in older adults who often experience age-related decline in immunity.

The interim analysis of the AReSVi 006 phase III trial investigating GSK’s RSV vaccine candidate for adults aged 60 years and above was reviewed by an Independent Data Monitoring Committee, and the primary endpoint was exceeded with no unexpected safety concerns observed.

Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said in a press release issued on June 10, 2022, “These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection. RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalizations and more than 24,000 deaths worldwide each year. Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”

GlaxoSmithKline plc (LSE/NYSE: GSK) is a science-led global healthcare company. For further information, please visit www.gsk.com/about-us.

RSV OA Vaccine Indication

According to the WHO, RSV represents a significant health threat for older adults (>65 years of age), with 360,000 hospitalizations and 24,000 deaths associated with RSV infections estimated annually in developed countries. The risk of severe disease in adults is increased by the presence of underlying chronic pulmonary disease, circulatory conditions, and functional disability and is associated with higher viral loads.

RSV OA Vaccine Dosage

Recent in-house results from a parallel phase III trial, AReSVi 004, showed that, in participants aged 60 years and above, one dose of the RSV OA investigational vaccine induced strong humoral and cellular immune responses, which remain above pre-vaccination levels up to at least the six months post-vaccination readout timepoint.

RSV OA Vaccine News 2021- 2022

June 10, 2022 - GSK plc announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial. The interim analysis indicates the primary endpoint was exceeded, with no unexpected safety concerns observed.

June 10, 2022 - Agenus shared that partner GSK announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial evaluating their investigational RSV vaccine in adults aged 60 years and above. The primary endpoint was exceeded, with no unexpected safety concerns observed.

February 16, 2021 - GSK announced Phase 3 RSV candidate program for older adults.  This phase 3 study is after the release of positive Phase I/II results on safety, reactogenicity, and immunogenicity.

November 23, 2020 - GlaxoSmithKline plc announced that patient dosing has begun in a phase 3 clinical program investigating the safety and efficacy of its Respiratory Syncytial Virus (RSV) candidate vaccine for maternal immunization (GSK3888550A), following the presentation of positive phase 1/2 safety, reactogenicity and immunogenicity data last month

RSV OA Vaccine Clinical Trials

The GSK RSVPreF3 RSV vaccine has been involved in over 10 clinical studies.

AReSVi 006 is a phase III trial investigating GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.

Clinical Trials

No clinical trials found