New Concepts of Biomarkers and Clinical Outcomes for Therapeutic Cancer Vaccines in Clinical Trials

Abstract

Aim

This study aimed to derive meaningful parameters for immune monitoring during cancer vaccine development by analysis of the literature.

Methods

This retrospective study was based on analysis of clinical trials registered at ClinicalTrials.gov and published data available on PubMed.

Results

The most common sample evaluated in immune monitoring was peripheral blood. All trials employed ELISA for detecting a humoral immune response; however, cellular immune assays were not used across trials. Most cellular immune assays failed to correlate with clinical outcome, although results of other methods did.

Conclusion

Standardization of the cellular immune assays across trials is important for predicting the effects of therapeutic cancer vaccines when considering the reliability and characteristics of the methods. Currently, assays mostly target detection of T-cell function, such as proliferation and cytokine release; however, T-cell phenotype analysis in peripheral blood and/or tumor sites may also be considered in the future.

Keywords::

• biomarker
• cancer
• immune monitoring
• immunotherapy
• regulatory science
• vaccine

Financial & competing interests disclosure

Ogi C is an employee of Merck Serono Co., Ltd but has not used this role to influence the results and discussion of this paper. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.