Drugs / AS01
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07527247 | Nov 2025 → Feb 2029 expected | — | Singapore General Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2023-02-15 | GlaxoSmithKline | Results Landmark New England Journal of Medicine publication reinforces potential of GSK’s respiratory syncytial virus older adult vaccine candidate gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the publication of positive phase III trial results for its respiratory syncytial virus (RSV) older adult vaccine candidate in the New England Journal of Medicine. |
| 2022-10-13 | Agenus Inc. | Results GSK’s older adult RSV vaccine candidate, containing Agenus’ QS-21 STIMULON™, shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial agenusbio.com ↗
The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1) against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial’s primary endpoint. |
| 2022-09-06 | GlaxoSmithKline | Regulatory WHO grants prequalification to GSK’s Mosquirix – the first and only approved malaria vaccine gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced today that the World Health Organization (WHO) has awarded prequalification to Mosquirix (also known as RTS,S/AS01), GSK’s groundbreaking malaria vaccine. |
| 2022-06-10 | Agenus Inc. | Results GSK’s RSV vaccine candidate for older adults, containing Agenus’ QS-21 STIMULON™ as part of GSK’s AS01 adjuvant, reports positive pivotal data supporting initiation of global regulatory submissions agenusbio.com ↗
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapies and adjuvants designed to activate the immune response to cancer and infections, today 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. |
| 2022-06-06 | VBI Vaccines Inc. | Results VBI Vaccines Presents Updated Phase 2a Tumor Response and Overall Survival Data for VBI-1901 in Recurrent GBM at the 2022 ASCO Annual Meeting vbivaccines.com ↗
Five (5) stable disease observed |
| 2021-10-13 | Dafra Pharma | Regulatory MALARIA VACCINE FOR CHILDREN AT RISK – October 6, 2021 dafrapharma.com ↗
The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. |
| 2021-06-08 | VBI Vaccines Inc. | Results VBI Vaccines Granted FDA Fast Track Designation for VBI-1901 for the Treatment of Recurrent GBM vbivaccines.com ↗
Study arm 2 : VBI-1901 + GSK’s AS01 B adjuvant system 1 6-month OS : 89% (n=8/9) – 12-month OS not yet reached |
| 2021-05-20 | VBI Vaccines Inc. | Results VBI Vaccines to Present Updated Phase 2a Tumor Response and Overall Survival Data for VBI-1901 in Recurrent GBM at 2021 ASCO Annual Meeting vbivaccines.com ↗
The e-poster presentation will highlight patient-specific tumor response data and improvement in overall survival (OS) compared to historical controls across both study arms: |
| 2020-10-21 | GlaxoSmithKline | Results GSK presents positive clinical data on maternal and older adults RSV candidate vaccines gsk.com ↗
Interim data presented at ID Week show that within one-month post-immunisation, the adjuvanted candidate vaccine has been well tolerated with no safety concerns identified. |
| 2015-10-27 | Agenus Inc. | Results GSK’s candidate Shingles Vaccine Containing Agenus’ QS-21 Stimulon® Demonstrates 90% Efficacy against Shingles and 89% Efficacy against Post-Herpetic Neuralgia in Adults aged 70 Years and Older agenusbio.com ↗
Agenus Inc. (NASDAQ:AGEN), an immunology company discovering and developing innovative treatments for cancer and other diseases, announced today that GlaxoSmithKline’s plc (LSE/NYSE:GSK) second pivotal Phase III efficacy study of its shingles vaccine candidate containing Agenus’ QS-21 Stimulon® adjuvant demonstrated 90% overall efficacy against shingles compared to placebo. |
| 2015-04-28 | Agenus Inc. | Results NEJM Publishes Study Showing GSK’s Shingles Vaccine Containing Agenus’ QS-21 Stimulon® Adjuvant Provides over 97% Protection in People Over the Age of 50 agenusbio.com ↗
The data show that GSK’s HZ/su reduced the risk of shingles (herpes zoster) by 97.2% in adults aged 50 and older, compared to placebo. |
| 2014-12-18 | Agenus Inc. | Results Positive Outcome of Phase 3 Study of GSK Shingles Vaccine Containing Agenus Adjuvant agenusbio.com ↗
Analysis of the primary endpoint showed that HZ/su reduced the risk of shingles by 97.2 per cent in adults aged 50 years and older compared to placebo. |
| 2013-10-07 | Agenus Inc. | Results GSK’s Vaccine Candidate Containing Agenus’ QS-21 Stimulon® Reduces Malaria Infection in Phase 3 Trials of Over 15,000 Children agenusbio.com ↗
These findings indicate that RTS,S has the potential to help prevent millions of malaria cases. |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AS01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07527247 ↗ |
| Modality | Other / unclassified | “AS01 is a liposome-based adjuvant used in licensed vaccines” NCT07527247 ↗ |
| Route | Intramuscular | “AS01 adjuvant (0.5 mL intramuscular)” NCT07527247 ↗ |