Trial NCT04695652
Publication Hsieh SM, Lancet, 2021
Dates: 2020-12-30 to 2021-04-02
Funding: Mixed (Medigen Vaccine Biologics; the Taiwan Centres for Disease Control, Ministry of Health and Welfare.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Taiwan Follow-up duration (months): 5 | |
| MVC-COV1901 (n = 3304) Placebo (n = 550) |
|
| Inclusion criteria | Adults aged 20 years or older; healthy or had stable pre-existing medical conditions; female participants of childbearing potential were required to take effective contraception from 14 days before screening to 30 days following the last injection of study intervention. |
| Exclusion criteria | Individuals who had travelled overseas within 14 days of screening, or those who planned to travel overseas within 6 months of the screening; immunosuppressive illness; history of autoimmune disease; malignancy with risk to recur; bleeding disorder; uncontrolled HIV infection; uncontrolled hepatitis B and C virus infections; SARS-CoV-1 or SARS-CoV-2 virus infections; an allergy to any vaccine; a serious medical condition that could interfere with the study. |
| Interventions | |
| Intervention
2 IM doses of 15 mcg MVC-COV1901, 28 days apart |
|
| Control
2 IM doses of placebo, 28 days apart | |
| Participants | |
| Randomized 3854 participants | |
| Characteristics of participants Type of participants: Adults N=3854 2172 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
| Description of participants Healthy adults and adults with stable pre-existing medical conditions at 11 centers in Taiwan. | |
| Primary outcome | |
| In the register 1) Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901), including: Solicited local AEs (up to 7 days after each dose of study intervention), Solicited systemic AEs (up to 7 days after each dose of study intervention), Unsolicited AEs (up to 28 days after each dose of study intervention), AE of Special Interest (AESI), Vaccine-Associated Enhanced Disease (VAED), Serious adverse events (SAEs); 2) Immunogenicity of MVC-COV1901 [ Time Frame: Day 1 to 28 days after second vaccination ]: neutralizing antibody titers | |
| In the report 1) Immediate adverse events, solicited local and systemic adverse events up to 7 days after each injection, unsolicited adverse events up to 28 days after each injection, and any other adverse events, serious adverse events, adverse events of special interest, and vaccineassociated enhanced disease that occurred throughout the study period; 2) neutralising antibody titres on day 1 and day 57 in terms of GMTs, the GMT ratio, and the seroconversion rate; 2) Neutralising antibody titres on day 1 and day 57 in terms of GMTs, the GMT ratio, and the seroconversion rate | |
| Variants description | |
| Variants | |
| Description * | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
No |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the published article, the trial registry, protocol with statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcomes in the published article reflect those in the registry. The study (n = 3854) achieved its target sample size (n = 3700). The report is of preliminary results at least one month after second dose and with median follow up of 63 days, with data cutoff on 2 June 2021. Long-term follow up (209 days) is ongoing. The analysis was for the purpose of regional submission of MVC-COV1901 for emergency use authorization, which has since been granted (on July 30, 2021). |