Phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of RVM-V001 administered as a single intramuscular injection in healthy adults. Three dose levels will be evaluated, with progression from low- to high-dose level based on the assessment of safety and tolerability. The study will be conducted at one or more sites in Australia.
Approximately 54 healthy non-pregnant female and male adults aged 18-65 years inclusive are planned to be enrolled in the study. All subjects will have completed either a 2-dose primary vaccination series with Pfizer Biontech-BNT162b2 SARS-CoV-2 vaccine (P) or Moderna mRNA-1273 (M) (as authorized/approved or as investigational product in a clinical trial), OR have completed the primary series and one homologous booster of Pfizer Biontech-BNT162b2 or mRNA-1273 i.e, P-P-P and M-M-M; the last dose in all cases should have been administered at least 6 months prior to enrollment. This study is composed of 3 dose groups, Groups 1, 2 and 3 per dose level. 18 eligible subjects in each dose group will receive RVM-V001 on Study Day 1 via intramuscular (IM) injection into deltoid muscle of the non-dominant arm. Subjects will be sequentially assigned to a dose group beginning with Group 1 (10 µg RVM-V001) based on the timing of completion of screening. As a precautionary step, 3 sentinel subjects, at least one male and one female will be used within each dose group. Enrollment of each dose group will start with the 3 sentinel subjects. After at least 2 days from the time of study vaccine administration of the 3 sentinel subjects, the 2-day safety data will be collected and reviewed by the principal investigator and local medical monitor. Should there be no safety concerns, the remaining subjects in the same dose group can be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
13
Northern Beaches Clinical Research
Brookvale, New South Wales, Australia
Core Research Group Pty Ltd
Brisbane, Queensland, Australia
Number of subjects with solicited adverse events
Time frame: Day 1 to Day 8 post dose
Number of subjects with solicited systemic adverse events
Time frame: Day 1 to Day 8 post dose
Number of subjects with unsolicited adverse events
Time frame: Day 1 to Day 29 post dose
Number of subjects with SAEs, SUSARs, MAAEs and AESIs
Time frame: Day 1 to Day 180 post dose
Changes in safety laboratory parameters from baseline by the Food and Drug Administration (FDA) toxicity grading scale.
Time frame: Day 1 to Day 180 post dose
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Time frame: Baseline and Day 29
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Time frame: Baseline and Day 29
GMT of serum binding antibodies (IgG) by ELISA
Time frame: Baseline and Day 29
Seroresponse rate for neutralizing antibody
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Time frame: Day 29
Seroresponse rate for binding antibodies (IgG) by ELISA
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Time frame: Day 29
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Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Time frame: Day 29
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Time frame: Days 15 and 180
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Time frame: Days 15 and 180
GMT of serum binding antibodies (IgG) by ELISA
Time frame: Days 15 and 180
Seroresponse rate for neutralizing antibody
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Time frame: Days 15 and 180
Seroresponse rate for binding antibodies (IgG) by ELISA
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Time frame: Days 15 and 180
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Time frame: Days 15 and 180
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Time frame: Days 15 and 180