Accelerate vaccine development using seamless phase 2/3 trial designs.
Expert Rev Vaccines
; 23(1): 523-534, 2024.
Article
em En
| MEDLINE
| ID: mdl-38682812
ABSTRACT
BACKGROUND:
Traditional vaccine development, often a lengthy and costly process of three separated phases. However, the swift development of COVID-19 vaccines highlighted the critical importance of accelerating the approval of vaccines. This article showcases a seamless phase 2/3 trial design to expedite the development process, particularly for multi-valent vaccines. RESEARCH DESIGN ANDMETHODS:
This study utilizes simulation to compare the performance of seamless phase 2/3 design with that of conventional trial design, specifically by re-envisioning a 9-valent HPV vaccine trial. Across three cases, several key performance metrics are evaluated overall power, type I error rate, average sample size, trial duration, the percentage of early stop, and the accuracy of dose selection.RESULTS:
On average, when the experimental vaccine was assumed to be effective, the seamless design that performed interim analyses based solely on efficacy saved 555.73 subjects, shortened trials by 10.29 months, and increased power by 3.70%. When the experimental vaccine was less effective than control, it saved an average of 887.73 subjects while maintaining the type I error rate below 0.025.CONCLUSION:
The seamless design proves to be a compelling strategy for vaccine development, given its versatility in early stopping, re-estimating sample sizes, and shortening trial durations.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Ensaios Clínicos Fase III como Assunto
/
Ensaios Clínicos Fase II como Assunto
/
Vacinas contra COVID-19
/
COVID-19
/
Desenvolvimento de Vacinas
Limite:
Humans
Idioma:
En
Revista:
Expert Rev Vaccines
Assunto da revista:
ALERGIA E IMUNOLOGIA
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
China