Trial NCT05289037
Publication Branche A, medRxiv, 2022
Dates: 2022-03-30 to 2022-05-06
Funding: Mixed (National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI), National Institutes of Health (NIH), Infectious Diseases Clinical Research Consortium (IDCRC), Department of Health and Human Services. All trial vaccines were provided by Moderna (Cambridge, MA).)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Multicenter / USA Follow-up duration (months): 3.0 | |
mRNA-1273 (original) (n = 99) mRNA-1273.529 (Omicron) + mRNA-1273.351 (Beta) (n = 202) mRNA-1273.529 (Omicron) + mRNA-1273.617.2 (Delta) (n = 101) mRNA-1273.529 (Omicron) monovalent (n = 100) mRNA-1273 (original) + mRNA-1273.529 (Omicron) (n = 100) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
1 IM dose 50 mcg mRNA-1273 (original), >16 weeks after last booster dose 1 IM dose 50 mcg mRNA-1273.529 (Omicron) + mRNA-1273.351 (Beta), >16 weeks after last booster dose 1 IM dose 50 mcg mRNA-1273.529 (Omicron) + mRNA-1273.617.2 (Delta), >16 weeks after last booster dose 1 IM dose 50 mcg mRNA-1273.529 (Omicron) monovalent, >16 weeks after last booster dose |
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Control
1 IM dose 50 mcg mRNA-1273 (original) + mRNA-1273.529 (Omicron), >16 weeks after last booster dose | |
Participants | |
Randomized 602 participants | |
Characteristics of participants Type of participants: Adults N=602 285 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 19-81 | |
Description of participants Adults with completed primary and booster COVID-19 vaccine series, either homologous or heterologous, and in stable health at 22 centers in USA. | |
Primary outcome | |
In the register 1) Change from baseline in Geometric Mean Fold Rise (GMFR) [ Time Frame: Day 1 through Day 366 ] (Specific and neutralizing antibodies); 2) Change from baseline in Geometric Mean Titers (GMT) [ Time Frame: Day 1 through Day 366 ] (Specific and neutralizing antibodies); 3) Change in Geometric Mean Ratio [ Time Frame: Day 1 through Day 366 ] (Specific and neutralizing antibodies) | |
In the report The magnitude, breadth and durability of SARS-CoV-2 specific antibody titers in serum samples by estimating 95% confidence intervals (CI) for the geometric mean titer (GMT) at each timepoint when samples are collected. | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
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 pre-print article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The article reports on six arms in an ongoing, adaptive trial with many other arms. There is no change from the trial registration in the intervention and control treatments. Efficacy outcomes were reported in the paper, but not pre-specified in the registry. The target sample size (n=600) specified in the registry was achieved (n=602). |