Trial NCT05216601
Publication Lien C, SSRN, 2022
Dates: 2022-05-01 to 2022-07-30
Funding: Private (Medigen Vaccine Biologics Corporation)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Multicenter / Taiwan (China) Follow-up duration (months): 0.9 | |
15 mcg MVC-COV1901 (n = 21) 15 mcg MVC-COV1901-Beta (n = 21) 25 mcg MVC-COV1901-Beta (n = 20) |
|
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Intervention
1 IM dose of 15 mcg MVC-COV1901-Beta (2nd booster) in 0.5 mL, at least 84 days (mean 128) after 3 IM doses (prime+1st booster) of MVC-COV1901. 1 IM dose of 25 mcg MVC-COV1901-Beta (2nd booster) in 0.5 mL, at least 84 days (mean 123) after 3 IM doses (prime+1st booster) of MVC-COV1901. |
|
Control
1 IM dose of 15 mcg MVC-COV1901 (2nd booster) in 0.5 mL, at least 84 days (mean 121) after 3 IM doses (prime+1st booster) of MVC-COV1901. | |
Participants | |
Randomized 62 participants | |
Characteristics of participants Type of participants: Adults including healthy or stable co-morbidities N=62 29 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
Description of participants Healthy adults or with stable co-morbidities that were HIV-negative and with no history of COVID-19 in 2 centres in Taiwan (China). | |
Primary outcome | |
In the register 1. Incidence of Adverse Events from Day 1 to 29 [Time Frame: Day 1 to Day 29]: To measure the incidence of adverse event from Day 1 to Day 28 after the booster dose. Solicited local adverse events (AEs) (up to 7 days after injection of booster dose); Solicited systemic AEs (up to 7 days after injection of booster dose); Unsolicited AEs (up to 28 days after injection of booster dose); AE of special interest (AESI); Vaccine-associated enhanced disease (VAED); Serious adverse event (SAE). 2. Primary Immunogenicity-1 [Time Frame: Day 1 to Day 29]: To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29; GMT. 3. Primary Immunogenicity-2 [Time Frame: Day 1 to Day 29]; To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29; GMT ratio. | |
In the report 1. incidence of adverse events (AEs) within 28 days of the booster administration: incidences of solicited AEs for up to seven days after each vaccination and unsolicited AEs for up to 28 days after each vaccination. Other AEs, such as serious adverse events (SAEs) and adverse events of special interest (AESI), were recorded within the study period. 2. levels of neutralising antibody titres at Visit 5 (4 weeks after the booster dose): assessed by neutralising assay with the original (WT) SARS-CoV-2 and Beta variant in terms of geometric mean titre (GMT) and GMT ratio. 3. levels of anti-spike immunoglobulin G (IgG) antibody titres at Visits 4 (2 weeks after the booster dose) and 5: assessed by IgG titres in terms of geometric mean titre (GMT) and GMT ratio. | |
Documents available |
Protocol NR Statistical plan * 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 2 versions of the pre-print article and its supplement, the study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. Preliminary analysis, follow-up visits were scheduled up to Day 181 after booster; results reported here up to 28 days follow-up. "As this was an exploratory phase 1 clinical study, the sample size was arbitrarily determined and was not derived from a statistical estimation method and a statistical hypothesis was not used for sample size calculation in this study." The primary outcomes in the article differed slightly from those in the registries, with a change of neutralizing antibody assessment from day 28 to day 14, and the addition of specific antibodies at day 28. There is no change from the trial registration in the intervention and control treatments. |