References
- Coronavirus COVID-19 global cases by the center for systems science and engineering (CSSE) at Johns Hopkins University (JHU); [accessed 2020 May 2]. https://coronavirus.jhu.edu/map.html
- COVID-19 vaccine candidates: 6 front-runners; [accessed 2020 May 2]. https://abcnews.go.com/Health/covid-19-vaccine-candidates-front-runners/story?id=69881230
- Zhu FC, Li YH, Guan XH, Hou LH, Wang WJ, Li JX, Wu SP, Wang BS, Wang Z, Wang L, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet 2020; 395: 1845-1854.
- Jamrozik E, Selgelid MJ. COVID-19 human challenge studies: ethical issues. Lancet Infect Dis. 2020;20(8):e198–e203. Epub ahead of print. doi:10.1016/S1473-3099(20)30438-2.
- World Health Organization. Human challenge trials for vaccine development: regulatory considerations; [accessed 2020 June 27]. https://www.who.int/biologicals/expert_committee/Human_ challenge _Trials_IK_final.pdf
- World Health Organization. Key criteria for the ethical acceptability of COVID-19 human challenge studies; [accessed 2020 June 27]. https://www.who.int/ethics/publications/key-criteria-ethical-acceptability-of-covid-19-human-challenge/en/
- WHO R&D Blueprint. Novel coronavirus: COVID-19 phase IIb/III vaccine trial synopsis; [accessed 2020 May 2]. https://www.who.int/blueprint/priority-diseases/key-action/COVID-19-vaccine-trial-synposis.pdf?ua=1
- Luczkowiak J, Arribas JR, Gómez S, Jiménez-Yuste V, de la Calle F, Viejo A, Delgado R. Specific neutralizing response in plasma from convalescent patients of ebola virus disease against the West Africa Makona variant of Ebola virus. Virus Res. 2016;213:224–29. doi:10.1016/j.virusres.2015.12.019.
- Hotez PJ, Corry DB, Strych U, Bottazzi ME. COVID-19 vaccines: neutralizing antibodies and the alum advantage. Nat Rev Immunol. 2020;20(7):399–400. Epub ahead of print. doi:10.1038/s41577-020-0358-6.
- Kester KE, Cummings JF, Ofori-Anyinam O, Ockenhouse CF, Kryzych U, Moris P, Schwenk R, Nielsen R, Debebe Z, Pinelis E, et al. Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS,S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis. 2009;200:337–46. doi:10.1086/600120.
- World Health Organization. Correlates of vaccine-induced protection: methods and implications; [accessed 2020 June 27]. https://apps.who.int/iris/bitstream/handle/10665/84288/WHO_IVB_ 13.01_eng.pdf;sequence=1
- Plotkin SA. Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010;17:1055–65. doi:10.1128/CVI.00131-10.
- Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28:182–91. doi:10.1016/j.cct.2006.05.007.
- Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomized trial: rationale, design, analysis, and reporting. BMJ. 2015;351:h391. doi:10.1136/bmj.h391.
- Ebola ça suffit ring vaccination trial con,sortium. The ring vaccination trial: a novel cluster randomized controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. BMJ. 2015;315:h3740.
- Henao-Restrepo AM, Camacho A, Longini IM, Watson CH, Edmunds WJ, Egger M, Carroll MW, Dean NE, Diatta I, Doumbia M, et al. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomized trial (Ebola Ça Suffit!). Lancet. 2017;389:505–18. doi:10.1016/S0140-6736(16)32621-6.
- Mössler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T. Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1. Vaccine. 2013;31:6194–200. doi:10.1016/j.vaccine.2013.10.061.
- Chen YH, Gesser R, Luxembourg A. A seamless phase IIB/III adaptive outcome trial: design rationale and implementation challenges. Clin Trials. 2015;12:84–90. doi:10.1177/1740774514552110.
- Food and Drug Administration. Adaptive designs for clinical trials of drug and biologics guidance for industry; [accessed 2020 May 2]. https://www.fda.gov/media/78495/download
- Berry SM, Connor JT, Lewis RJ. The platform trial: an efficient strategy for evaluating multiple treatments. JAMA. 2015;313(16):1619–20. doi:10.1001/jama.2015.2316.
- Saville BR, Berry SM. Efficiencies of platform trials: A vision of the future. Clin Trials. 2016;13:358–66. doi:10.1177/1740774515626362.
- Cummings J, Aisen P, Barton R, Bork J, Doody R, Dwyer J, Egan JC, Feldman H, Lappin D, Truyen L, et al. Re-engineering alzheimer clinical trials: global alzheimer’s platform network. J Prev Alzheimers Dis. 2016;3:114–20. doi:10.14283/jpad.2016.93.
- World Health Organization. “Solidarity” clinical trial for COVID-19 treatments; [accessed 2020 June 27]. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments#:~:text=Solidarity%E2%80%9D%20is%20an%20international%20clinical%20trial%20to%20help,care%2C%20to%20assess%20their%20relative%20effectiveness%20against%20COVID-19.
- Food and Drug Administration. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics guidance for industry; [accessed 2020 June 27]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-efficient-clinical-trial-design-strategies-expedite-development-oncology-drugs-and
- ClinicalTrials.gov. Study to describe the safety, tolerability, immunogenicity, and potential efficacy of RNA vaccine candidates against COVID-19 in healthy adults; [accessed 2020 June 27]. https://clinicaltrials.gov/ct2/show/NCT04368728?cond=COVID-19+vaccine&draw=3&rank=11
- ClinicalTrials.gov. Phase Ib-II trial of dendritic cell vaccine to prevent COVID-19 in adults; [accessed June 27, 2020]. https://clinicaltrials.gov/ct2/show/NCT04386252?cond=COVID-19+vaccine&draw=3&rank=16
- ClinicalTrials.gov. Phase I/II clinical trial of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Canada; [accessed 2020 June 27]. https://clinicaltrials.gov/ct2/show/NCT04398147?cond=COVID-19+vaccine&draw=3&rank=28