Abstract
Design This is a phase 1, dose-escalation open-label trial to evaluate the safety and immunogenicity of MVC-COV1901, a recombinant stabilized prefusion SARS-CoV-2 spike (S-2P) protein vaccine with adjuvant of aluminum hydroxide and CpG 1018.
Methods We enrolled 45 healthy adults from 20 to 49 years of age to be administered with two vaccinations of MVC-COV1901 in a low dose (LD), middle dose (MD), and high dose (HD) of spike protein at 28 days apart. There were 15 participants in each dose group, and all of them were followed up for 28 days after the second vaccination at the time of interim analysis. Adverse events (AEs) and laboratory data were recorded for safety evaluation. Blood samples were collected for wild-type SARS-CoV-2 and pseudovirus neutralization assays as well as SARS-CoV-2 spike-specific immunoglobulin G (IgG) at various times. Overall, the study duration will be 7 months.
Results Solicited events were mostly mild and similar in the participants of all three dose groups. No subject experienced fever. There were no serious nor adverse events of special interest at the time point of this interim report. After the second vaccination, the SARS-CoV-2 spike specific IgG titers increased with peak geometric mean titers at 7178.245 (LD), 7746.086 (MD), and 11220.58 (HD), respectively. Serum neutralizing activity was detected by two methods in all participants of MD and HD groups, with geometric mean values generally comparable to those of a panel of control convalescent serum specimens. All of the participants in the MD and HD groups were seroconverted after the second vaccination.
Conclusions The MVC-COV1901 vaccine is safe and elicits remarkable immune responses especially in the MD and HD groups.
Trial Registration ClinicalTrials.gov NCT 04487210
Competing Interest Statement
Szu-Min Hsieh, Shan-Chwen Chang, Wang-Da Liu, Yu-Shan Huang declared that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper; Yi-Jiun Lin, Erh-Fang Hsieh, Wei-Cheng Lian, Charles Chen, I-Chen Tai reported grants from Taiwan Centers for Disease Control, Ministry of Health and Welfare, during the conduct of the study. In addition, Yi-Jiun Lin and Charles Chen have a patent US63/040,696 pending.
Clinical Trial
NCT04487210
Funding Statement
Taiwan Centers for Disease Control, Ministry of Health and Welfare provided grant funding for this study, but does not necessarily stand by any commentary made in this paper.Medigen Vaccine Biologics Corp. was the study sponsor and manufacturer of the investigational vaccine, and co-designed the trial, provided the study product, and coordinated interactions with regulatory authorities. The sponsors used contract clinical research organization to oversee clinical site operations. Data were collected by the clinical site research staff, managed by a contract research organization data management team, monitored by a contract research organization, and overseen by the sponsor and an independent data and safety monitoring board. The interim analysis was performed by the contract research organization. Data interpretation, manuscript preparation were performed by the authors and the decision to submit the manuscript for publication was made by the authors.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The protocol has been approved by the 132nd meeting of Research Ethics Committee C of the National Taiwan University Hospital (NTUH) on Aug 3, 2020. The committee is organized under, and operates in accordance with, the Good Clinical Practice guidelines and governmental laws and regulations. Approval by the Ministry of Health and Welfare is mandatory before project implementation. The duration of this approval is six months (Aug 6, 2020 to Feb 5, 2021). The investigator is required to report Serious Adverse Events and Unanticipated Problems in accordance with the governmental laws and regulations and NTUH requirements and apply for a continuing review not less than six weeks prior to the approval expiration date. Chairman of Research Ethics Committee C: Daniel Fu-Chang Tsai, M.D. NTUH-REC No. 202007029MSC Protocol No. CT-COV-11
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Data Availability
The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable and expressively written request.
