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A Systematic Review of Human Challenge Trials, Designs, and Safety
Jupiter Adams-Phipps1, Danny Toomey1,2, Witold Więcek1
11Day Sooner Research Team, Lewes, Delaware, USA.
Summary
Human challenge trials (HCTs) are increasingly common, with severe adverse events (SAEs) and adverse events (AEs) being rare. While reporting of safety data has improved, many HCTs still lack comprehensive health impact information.
Area of Science:
- Clinical Research
- Infectious Diseases
- Pharmacology
Background:
- Participant safety in human challenge trials (HCTs) requires further assessment.
- Key questions involve the risk, incidence of adverse events (AEs), serious adverse events (SAEs), and effectiveness of risk mitigation in HCTs.
Purpose of the Study:
- To systematically evaluate participant safety in human challenge trials (HCTs).
- To determine the frequency of adverse events (AEs) and serious adverse events (SAEs) in HCTs.
- To assess the effectiveness of risk mitigation strategies employed in HCTs.
Main Methods:
- A systematic literature search of PubMed and PubMed Central was conducted for HCT studies published between 1980 and 2021.
- Screened 2838 articles, with 276 undergoing full review.
- Included 308 studies detailing 15,046 challenged participants.
Main Results:
- Over 92% of studies reported risk mitigation measures.
- Less than 0.2% of participants experienced a challenge-related serious adverse event (SAE).
- Severe adverse events (AEs) ranged from 5.6% to 15.8% of participants, with reporting variability.
Conclusions:
- Human challenge trials (HCTs) are becoming more prevalent for various diseases.
- While severe adverse events (SAEs) and adverse events (AEs) are infrequent, comprehensive safety data reporting remains inconsistent.
- Improved trial registration and safety data reporting are noted, but gaps persist.
Keywords:
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