A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
Summary
This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.
Timeline
- Start
- 2015-09-29
- Primary completion
- 2016-09-09
- Completion
- 2016-11-07
Outcome
Missed primary endpoint
Stopped (Enrollment): “Year 1 of study completed. No enrollment planned for Year 2 of study.”
registry analysis (superiority test); Placebo + IIV vs MEDI7510 + IIV; Vaccine efficacy -7.1 (90% CI -106.9 to 44.3) NCT02508194 ↗
paper CONCLUSION: The RSV vaccine was immunogenic but did not protect older adults from RSV illness. PMID 29029260 ↗
Publications
- Chang LA, Phung E, Crank MC, Morabito KM, Villafana T, Dubovsky F, Falloon J, Esser MT, Lin BC, Chen GL, Graham BS, Ruckwardt TJ. A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine. Sci Transl Med. 2022 Dec 21;14(676):eade0424. doi: 10.1126/scitranslmed.ade0424. Epub 2022 Dec 21.
- Falloon J, Yu J, Esser MT, Villafana T, Yu L, Dubovsky F, Takas T, Levin MJ, Falsey AR. An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults. J Infect Dis. 2017 Dec 12;216(11):1362-1370. doi: 10.1093/infdis/jix503.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MEDI7510 | Vaccine | 120 ug | Intramuscular |
| Background | Inactivated Influenza Vaccine | Vaccine | — | — |