ArticleContemporary clinical trials2021
Innovative trial designs and analyses for vaccine clinical development.
Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Artificial intelligence in vaccine research and development: an umbrella review.Frontiers in immunology · 2025Pooled it
- Treating intrusive memories after trauma in healthcare workers: a Bayesian adaptive randomised trial developing an imagery-competing task intervention.Molecular psychiatry · 2023Trial
- Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial.The Journal of infectious diseases · 2022Trial
- AI-driven big data analysis and predictive modeling of infectious disease immunity: from correlates to causal, multiscale understanding.Archives of microbiology · 2026Review
- RISE: Two-Stage Rank-Based Identification of High-Dimensional Surrogate Markers Applied to Vaccinology.Statistics in medicine · 2025Article
- Insight and benefits from vaccine clinical trials with adaptive designs: a scoping review.Translational and clinical pharmacology · 2025Article
- Prototype master protocol for benchmarking of real-world follow-up data in glaucoma.Acta ophthalmologica · 2025Article
- De-risking vaccine development: lessons, challenges, and prospects.NPJ vaccines · 2025Review
- Engaging Broader Stakeholders to Accelerate Group AVaccines · 2025Review
- Leveraging implementation science in clinical trials of vaccines in the global south.Nature medicine · 2025Article
- Past, present, and future of Phase 3 vaccine trial design: rethinking statistics for the 21st century.Clinical and experimental immunology · 2025Review
- Innovative approaches for vaccine trials as a key component of pandemic preparedness - a white paper.Infection · 2024Review
- Using the 'Leapfrog' Design as a Simple Form of Adaptive Platform Trial to Develop, Test, and Implement Treatment Personalization Methods in Routine Practice.Administration and policy in mental health · 2024Article
- Vaccine value profile for Chikungunya.Vaccine · 2024Article
- Recent innovations in adaptive trial designs: A review of design opportunities in translational research.Journal of clinical and translational science · 2023Review
- Lessons for the HIV response from structural innovations catalysed by COVID-19.BMJ global health · 2022Article
- Review
- A dose-reduction HPV vaccine immunobridging trial of two HPV vaccines among adolescent girls in Tanzania (the DoRIS trial) - Study protocol for a randomised controlled trial.Contemporary clinical trials · 2021Article
- New, Shorter Small-Sample Intervals for Vaccine Efficacy.Pharmaceutical statisticsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the past decades, the world has experienced several major virus outbreaks, e.g. West African Ebola outbreak, Zika virus in South America and most recently global coronavirus (COVID-19) pandemic. Many vaccines have been developed to prevent a variety of infectious diseases successfully. However, several infections have not been preventable so far, like COVID-19, which induces an immediate urgent need for effective vaccines. These emerging infectious diseases often pose unprecedent challenges for the global heath community as well as the conventional vaccine development paradigm. With a long and costly traditional vaccine development process, there are extensive needs in innovative vaccine trial designs and analyses, which aim to design more efficient vaccines trials. Featured with reduced development timeline, less resource consuming or improved estimate for the endpoints of interests, these more efficient trials bring effective medicine to target population in a faster and less costly way. In this paper, we will review a few vaccine trials equipped with adaptive design features, Bayesian designs that accommodate historical data borrowing, the master protocol strategy emerging during COVID-19 vaccine development, Real-World-Data (RWD) embedded trials and the correlate of protection framework and relevant research works. We will also discuss some statistical methodologies that improve the vaccine efficacy, safety and immunogenicity analyses. Innovative clinical trial designs and analyses, together with advanced research technologies and deeper understanding of the human immune system, are paving the way for the efficient development of new vaccines in the future.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.