Related Experiment Video

Updated: Dec 15, 2025

Intravenous Endotoxin Challenge in Healthy Humans: An Experimental Platform to Investigate and Modulate Systemic Inflammation
07:48

Intravenous Endotoxin Challenge in Healthy Humans: An Experimental Platform to Investigate and Modulate Systemic Inflammation

Published on: May 16, 2016

12.0K

Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines

Robert Steel1, Lara Buchak2, Nir Eyal3

  • 1Center for Population-Level Bioethics and Department of Philosophy, Rutgers University, New Brunswick, New Jersey, USA.

Journal of Medical Ethics
|July 15, 2020
PubMed

Insights

Controlled human infection trials can accelerate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine development. This study defends the ethical and scientific viability of these SARS-CoV-2 challenge studies despite existing uncertainties.

Area of Science:

  • Infectious Diseases
  • Vaccinology
  • Bioethics

Background:

  • The COVID-19 pandemic necessitates rapid vaccine development.
  • Controlled human infection (challenge) trials are proposed as an accelerated pathway.
  • Ethical considerations regarding participant risk in challenge trials require careful examination.

Purpose of the Study:

  • To advocate for the responsible implementation of SARS-CoV-2 challenge trials.
  • To address concerns about the uncertainties surrounding COVID-19 risks in trial design.

Main Methods:

  • Ethical and scientific defense of controlled human infection models.
  • Analysis of existing data on SARS-CoV-2 infection and disease progression in young, healthy individuals.
  • Risk-benefit assessment for volunteer participants.

Main Results:

  • Controlled human infection trials offer a faster route to vaccine efficacy data.
  • The risks associated with SARS-CoV-2 in specific volunteer populations are sufficiently understood for ethical trial conduct.
  • Potential benefits of accelerated vaccine availability outweigh the calculated risks.

Conclusions:

  • SARS-CoV-2 challenge trials are a scientifically sound and ethically justifiable method for rapid vaccine development.
  • Further research and stringent protocols can ensure participant safety.
  • Accelerated vaccine deployment through challenge trials can mitigate pandemic impact.
Keywords:
clinical trialsethicsphilosophical ethicsresearch ethics

More Related Videos

In Vitro Tumor Cell Rechallenge For Predictive Evaluation of Chimeric Antigen Receptor T Cell Antitumor Function08:04

In Vitro Tumor Cell Rechallenge For Predictive Evaluation of Chimeric Antigen Receptor T Cell Antitumor Function

Published on: February 27, 2019

12.3K
Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development09:03

Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development

Published on: June 19, 2018

9.1K

Related Concept Videos

Vaccinations01:51

Vaccinations

Overview
50.7K
Cancer Vaccines01:30

Cancer Vaccines

Cancer treatment vaccines are a rapidly evolving field that offers a promising approach to immunotherapy. Unlike traditional vaccines that prevent diseases, cancer treatment vaccines are designed to treat existing cancers by stimulating the immune system to recognize and attack cancer cells.
Cancer vaccines come in two categories: preventive (prophylactic) and treatment (active). Preventive vaccines, such as the Human Papillomavirus (HPV) vaccine, protect against viruses that cause certain...
861
Uncertainty: Confidence Intervals00:54

Uncertainty: Confidence Intervals

The confidence interval is the range of values around the mean that contains the true mean. It is expressed as a probability percentage. The interpretation of a 95% confidence interval, for instance, is that the statistician is 95% confident that the true mean falls within the interval. The upper and lower limits of this range are known as confidence limits. The confidence limits for the true mean are estimated from the sample's mean, the standard deviation, and the statistical factor...
9.3K
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
127
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.4K