ArticleBiometrical journal. Biometrische Zeitschrift2021
Assurance in vaccine efficacy clinical trial design based on immunological responses.
Article in Biometrical journal. Biometrische Zeitschrift, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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
5 citing papers in PubMed.
- Trial
- Current status of vaccine clinical trials registered on China's Drug Trial Registration and information disclosure platform, 2013-2024.Frontiers in public health · 2026Article
- Improving precision of vaccine efficacy evaluation using immune correlate data in time-to-event models.NPJ vaccines · 2024Article
- Effective Pre-Clinical Treatment of Fish Envenoming with Polyclonal Antiserum.International journal of molecular sciences · 2023Article
- Assurance in vaccine efficacy clinical trial design based on immunological responses.Biometrical journal. Biometrische Zeitschrift · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The assurance of a future clinical trial is a key quantitative tool for decision-making in drug development. It is derived from prior knowledge (Bayesian approach) about the clinical endpoint of interest, typically from previous clinical trials. In this paper, we examine assurance in the specific context of vaccine development, where early development (Phase 2) is often based on immunological endpoints (e.g., antibody levels), while the confirmatory trial (Phase 3) is based on the clinical endpoint (very large sample sizes and long follow-up). Our proposal is to use the Phase 2 vaccine efficacy predicted by the immunological endpoint (using a model estimated from epidemiological studies) as prior information for the calculation of the assurance.
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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.