A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers
This was a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, and immunogenicity of RBM-001 in healthy adults. Participants were randomized to receive RBM-001 at 5 µg or 25 µg, or placebo, administered by intramuscular injection. Two vaccinations were planned 21 days apart. Safety and tolerability were assessed through solicited and unsolicited adverse events, adverse events of special interest, medically attended adverse events, new-onset chronic medical conditions, serious adverse events, clinical laboratory assessments, vital signs, electrocardiograms, and physical examinations. Immunogenicity assessments included antigen-specific antibody responses, SARS-CoV-2-specific T-cell responses, and cytokine responses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
To evaluate the safety and tolerability of the RBM-001 vaccination in healthy adults.
QPS Miami
Miami, Florida, United States
Occurrence, severity, and relationship of solicited local and general adverse events (AEs) during the 7 days following each vaccination.
Number and percentage of participants with solicited local and general adverse events, summarized by severity and relationship to study vaccination.
Time frame: Day 1 to Day 8 after first vaccination, Day 22 to Day 29 after second vaccination
Occurrence, severity, and relationship of unsolicited AEs during the 21 days following each vaccination
Number and percentage of participants with unsolicited adverse events, summarized by severity and relationship to study vaccination.
Time frame: Day 1 (post-vaccination) to Day 21 for first vaccination, Day 22 (post-vaccination) to Day 43
Occurrence, severity and relationship of adverse events of special interest (AESIs) from the first vaccination through the 28 days following the second vaccination.
Number and percentage of participants with adverse events of special interest (AESIs), summarized by severity and relationship to study vaccination.
Time frame: Day 1 through Day 50
Occurrence, severity, and relationship of medically-attended AEs (MAAEs), new-onset chronic medical conditions (NOCMCs), and serious adverse events (SAEs) through the study completion
Number and percentage of participants with medically attended adverse events (MAAEs), new-onset chronic medical conditions (NOCMCs), and serious adverse events (SAEs), summarized by severity and relationship to study vaccination, as applicable.
Time frame: Day 1 through Day 383 (End of study follow-up period)
Occurrence of clinically significant changes in clinical laboratory results, vital signs results, 12-lead ECG results, and physical examination findings
Number and percentage of participants with clinically significant changes in clinical laboratory results, vital signs, 12-lead electrocardiogram results, and physical examination findings.
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Time frame: Day 1 through Day 383 (End of Study)
Geometric mean titer (GMT) of antigen specific antibody
Antigen-specific antibody titers measured by enzyme-linked immunosorbent assay (ELISA) and summarized as geometric mean titers (GMTs) at scheduled study time points.
Time frame: Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113
The geometric mean fold rise (GMFR) in antigen specific antibody titer from baseline
Antigen-specific antibody titers measured by ELISA and summarized as geometric mean fold rise (GMFR) from baseline at scheduled post-vaccination time points.
Time frame: Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113
Activation of SARS-CoV-2 specific cytotoxic T-cells and helper T-cells
SARS-CoV-2 antigen-specific cytotoxic CD8+ T-cell and helper CD4+ T-cell responses assessed by flow cytometry at scheduled study time points.
Time frame: Day -1, Day 21, Day 43 and Day 113
Assessment of specific cytokine levels from baseline through scheduled timepoints throughout study
Cytokine responses assessed at scheduled study time points, including IL-2, IL-12, TNF-α, IFN-γ, IL-1β, IL-4, IL-6, IL-8, IL-10, and IL-13.
Time frame: Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113