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Are placebo controls necessary in controlled human infection trials for vaccines?

Marijke C C Langenberg1, Olaf M Dekkers2, Meta Roestenberg3

  • 1Department of Parasitology, Leiden University Medical Center, Leiden, Netherlands.

The Lancet. Infectious Diseases
|March 7, 2020
PubMed

Insights

Controlled human infection trials can use historical data instead of placebo groups to assess vaccine efficacy. This approach minimizes participant risk while ensuring scientifically valid outcomes for vaccine development.

Area of Science:

  • Vaccinology
  • Infectious Diseases
  • Clinical Trials

Background:

  • Controlled human infection trials (CHITs) are crucial for early vaccine efficacy assessment.
  • Participant safety is paramount, necessitating small group sizes and ethical controls.
  • Traditional CHITs often employ placebo groups, raising ethical and logistical considerations.

Purpose of the Study:

  • To evaluate the scientific justification and considerations for using historical data as a control in CHITs.
  • To propose historical data as a viable alternative to placebo groups in vaccine development.
  • To advocate for data sharing and centralization within the scientific community for CHITs.

Main Methods:

  • Review of existing literature and ethical frameworks for CHITs.
  • Analysis of the scientific validity of using historical infection rate data.
  • Discussion of the practical implementation of historical data controls.

Main Results:

  • Historical data can provide a scientifically sound alternative to placebo controls in CHITs.
  • Using historical data minimizes cumulative risk to participants by reducing the need for large control groups.
  • Consistent infection rates in CHITs support the use of historical data for comparable outcomes.

Conclusions:

  • Historical data offers a robust and ethical alternative to placebo groups in controlled human infection trials.
  • Widespread adoption requires centralizing and sharing data from CHITs.
  • This approach can accelerate the selection of promising vaccine candidates for further development.

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