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

[HTML][HTML] … 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 …

[HTML][HTML] 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, 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-…

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…

[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 …

Human safety, tolerability, and pharmacokinetics of molnupiravir, a novel broad-spectrum oral antiviral agent with activity against SARS-CoV-2

WP Painter, W Holman, JA Bush… - Antimicrobial agents …, 2021 - Am Soc Microbiol
… An oral solution of the study drug in the single ascending dose part of the study allowed the
greatest flexibility in initial dose escalation, based on safety and level of exposure. A capsule …

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 …

[HTML][HTML] … , double-blinded, placebo-controlled and dose-escalation study to evaluate the safety and immunogenicity of the intranasal DelNS1-nCoV-RBD LAIV for …

R Zhang, KH Chan, P Wang, R Zhou, HKC Yau… - Vaccines, 2023 - mdpi.com
… -RBD LAIV vaccine could elicit mucosal immunity against SARS-CoV-2, as the vaccine was
… The saliva total Ig against SARS-CoV-2 RBD of the high-dose vaccine was significantly …

[HTML][HTML] Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non …

PM Folegatti, M Bittaye, A Flaxman… - The Lancet Infectious …, 2020 - thelancet.com
… It is the sixth coronavirus known to cause human … coronavirus (SARS-CoV), which was
responsible for the 2002–03 SARS global epidemic and SARS coronavirus 2 (SARS-CoV-2), …