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- Title
First Do No Harm? Modeling Risks and Benefits of Challenge Trials for Hepatitis C Vaccine Development.
- Authors
Bilinski, Alyssa; Slimovitch, Rachel; Mendlowitz, Andrew; Feld, Jordan J; Salomon, Joshua A
- Abstract
Background In 2019, about 58 million individuals were chronically infected with hepatitis C virus. Some experts have proposed challenge trials for hepatitis C virus vaccine development. Methods We modeled incremental infections averted through a challenge approach, under varying assumptions regarding trial duration, number of candidates, and vaccine uptake. We computed the benefit-risk ratio of incremental benefits to risks for challenge versus traditional approaches. We also benchmarked against monetary costs of achieving incremental benefits through treatment. Results Our base case assumes 3 vaccine candidates, each with an 11% chance of success, corresponding to a 30% probability of successfully developing a vaccine. Given this probability, and assuming a 5-year difference in duration between challenge and traditional trials, a challenge approach would avert an expected 185 000 incremental infections with 20% steady-state uptake compared to a traditional approach and 832 000 with 90% uptake (quality-adjusted life-year benefit-risk ratio, 72 000 & 323 000). It would cost at least $92 million and $416 million, respectively, to obtain equivalent benefits through treatment. BRRs vary considerably across scenarios, depending on input assumptions. Conclusions Benefits of a challenge approach increase with more vaccine candidates, faster challenge trials, and greater uptake.
- Subjects
HEPATITIS C prevention; VACCINES; IMMUNIZATION; VIRAL hepatitis; VACCINE development; MEDICAL care costs; RISK assessment; TREATMENT effectiveness; BENCHMARKING (Management); DESCRIPTIVE statistics; RESEARCH funding; DRUG side effects; PREDICTION models; PROBABILITY theory; QUALITY-adjusted life years
- Publication
Clinical Infectious Diseases, 2023, Vol 77, pS231
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciad379