Human Challenge Studies Are Unlikely to Accelerate Coronavirus Vaccine Licensure Due to Ethical and Practical Issues

Stanley M Spinola^{1

2

3}, Gregory D Zimet⁴, Mary A Ott^{4

5}, Barry P Katz⁶

Affiliations

¹ Department of Microbiology and Immunology, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
² Department of Medicine, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
³ Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
⁴ Department of Pediatrics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
⁵ Center for Bioethics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
⁶ Department of Biostatistics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.

PMID: 32845303
PMCID: PMC7499586
DOI: 10.1093/infdis/jiaa457

Comment

Human Challenge Studies Are Unlikely to Accelerate Coronavirus Vaccine Licensure Due to Ethical and Practical Issues

Stanley M Spinola et al. J Infect Dis. 2020.

. 2020 Oct 1;222(9):1572-1574.

doi: 10.1093/infdis/jiaa457.

Authors

Stanley M Spinola^{1

2

3}, Gregory D Zimet⁴, Mary A Ott^{4

5}, Barry P Katz⁶

Affiliations

¹ Department of Microbiology and Immunology, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
² Department of Medicine, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
³ Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
⁴ Department of Pediatrics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
⁵ Center for Bioethics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
⁶ Department of Biostatistics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.

PMID: 32845303
PMCID: PMC7499586
DOI: 10.1093/infdis/jiaa457

Erratum in

Corrigendum to: Human Challenge Studies Are Unlikely to Accelerate Coronavirus Vaccine Licensure due to Ethical and Practical Issues.
Spinola SM, Zimet GD, Ott MA, Katz BP. Spinola SM, et al. J Infect Dis. 2021 May 28;223(10):1837. doi: 10.1093/infdis/jiab109. J Infect Dis. 2021. PMID: 33871610 Free PMC article. No abstract available.

No abstract available

PubMed Disclaimer

Comment in

Reply to Hasford and to Spinola et al.
Eyal N, Lipsitch M, Smith PG. Eyal N, et al. J Infect Dis. 2020 Oct 1;222(9):1574-1575. doi: 10.1093/infdis/jiaa458. J Infect Dis. 2020. PMID: 32845306 Free PMC article. No abstract available.

Comment on

Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure.
Eyal N, Lipsitch M, Smith PG. Eyal N, et al. J Infect Dis. 2020 May 11;221(11):1752-1756. doi: 10.1093/infdis/jiaa152. J Infect Dis. 2020. PMID: 32232474 Free PMC article.

References

1. Eyal N, Lipsitch M, Smith PG. Human challenge studies to accelerate coronavirus vaccine licensure. J Infect Dis 2020; 221:1752–6. - PMC - PubMed
1. Miller FG, Grady C. The ethical challenge of infection-inducing challenge experiments. Clin Infect Dis 2001; 33:1028–33. - PubMed
1. Beigel JH, Tomashek KM, Dodd LE, et al. . Remdesivir for the treatment of Covid-19 - preliminary report. N Engl J Med 2020. doi:10.1056/NEJMoa2007764 - DOI - PubMed
1. Janowicz DM, Ofner S, Katz BP, Spinola SM. Experimental infection of human volunteers with Haemophilus ducreyi: fifteen years of clinical data and experience. J Infect Dis 2009; 199:1671–9. - PMC - PubMed
1. Forster P, Forster L, Renfrew C, Forster M. Phylogenetic network analysis of SARS-CoV-2 genomes. Proc Natl Acad Sci U S A 2020; 117:9241–3. - PMC - PubMed

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Human Challenge Studies Are Unlikely to Accelerate Coronavirus Vaccine Licensure Due to Ethical and Practical Issues

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Human Challenge Studies Are Unlikely to Accelerate Coronavirus Vaccine Licensure Due to Ethical and Practical Issues

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