Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study

SH Khoo, R Fitzgerald, T Fletcher… - Journal of …, 2021 - academic.oup.com
… the current dose was safe and to dose escalate and could decide to skip a dose if it did
not more than double and was deemed safe by the Bayesian model. Once the dose-escalation

… response against omicron variants after three doses of subunit SARS-CoV-2 vaccine MVC-COV1901: an extension to an open-label, dose-escalation phase 1 study

SM Hsieh, SC Chang, HY Cheng, SR Shih… - Infectious Diseases and …, 2022 - Springer
… This study was an extension to the phase 1 main study, which was a prospective, open-label,
dose-escalation study to evaluate the safety and immunogenicity of a SARS-CoV-2 …

Prioritizing second-generation SARS-CoV-2 vaccines through low-dosage challenge studies

B Steuwer, E Jamrozik, N Eyal - International Journal of Infectious Diseases, 2021 - Elsevier
… are performed for different purposes with a single preliminary dose escalation study. Once
a relatively low endpoint is met, the dose escalation study identifies the dose for a first, low-…

Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults

EJ Anderson, NG Rouphael, AT Widge… - … England Journal of …, 2020 - Mass Medical Soc
… We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine,
mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in …

An mRNA vaccine against SARS-CoV-2—preliminary report

LA Jackson, EJ Anderson, NG Rouphael… - New England journal …, 2020 - Mass Medical Soc
… We conducted a phase 1, dose-escalation, open-label clinical trial designed to determine …
dose of 25 μg, 100 μg, or 250 μg. On the basis of the results obtained in patients at these dose

Safety, tolerability, viral kinetics, and immune correlates of protection in healthy, seropositive UK adults inoculated with SARS-CoV-2: a single-centre, open-label …

S Jackson, JL Marshall, A Mawer… - The Lancet …, 2024 - thelancet.com
… the dose escalationdosing group from 1×101 to 1×105 TCID50 SARS-CoV-2. All volunteers
have completed quarantine, with follow-up to 12 months complete. Despite dose escalation

Safety and immunogenicity of the inactivated whole-virus adjuvanted COVID-19 vaccine VLA2001: a randomized, dose escalation, double-blind phase 1/2 clinical trial …

R Lazarus, C Taucher, C Brown, IČ Ramljak, L Danon… - Journal of Infection, 2022 - Elsevier
… 2 weeks after completion of the two-dose priming schedule, showed significantly higher
GMTs of SARS-CoV-2 neutralizing antibody titres in the highest dose group (GMT 545.6; 95% CI…

Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in …

FC Zhu, YH Li, XH Guan, LH Hou, WJ Wang, JX Li… - The Lancet, 2020 - thelancet.com
… We also measured the neutralising antibody responses induced by vaccination using
both live SARS-CoV-2 virus neutralisation (virus strain SARS-CoV-2/human/CHN/Wuhan_IME-…

Tolerability, safety and immunogenicity of intradermal delivery of a fractional dose mRNA-1273 SARS-CoV-2 vaccine in healthy adults as a dose sparing strategy

GVT Roozen, MLM Prins, R van Binnendijk, G Hartog… - medRxiv, 2021 - medrxiv.org
… We report results of a proof of concept, open-label, dose-escalation vaccine trial, and
show … In this study, we showed that a two-dose regimen of 10 µg or 20 µg mRNA SARS-CoV-2 …

[HTML][HTML] … SARS-CoV-2 spike protein vaccine (MVC COV1901) adjuvanted with CpG 1018 and aluminum hydroxide in healthy adults: a phase 1, dose-escalation study

SM Hsieh, WD Liu, YS Huang, YJ Lin, EF Hsieh… - …, 2021 - thelancet.com
… This study was a dose escalation study with three separate groups of participants 20 to
49 years of age. Each sub-phase consisted of 15 participants. The three different …