Phase 1b, randomized, open-label, study to evaluate the safety, tolerability, and immunogenicity of RVM-V001 only, RVM-V002 only, or RVM V001 + RVM V002 (Co administered as Separate Injections) in healthy adults. The study will be conducted at one site in Singapore.
A total of 48 healthy men and non-pregnant women aged 21 years and older will be stratified by prior vaccination. Twenty-four subjects who have received a 3 dose primary vaccination series, with or without 1 booster dose, of an approved inactivated virus vaccine (BBIBP-CorV or CoronaVac) will be randomized at a 1:1:1 ratio to receive RVM V001 (30 µg) only, RVM V002 (30 µg) only, or RVM-V001 (15 µg) + RVM V002 (15ug). An additional 24 subjects who have received 3 doses (primary vaccination series and 1 booster dose) of an mRNA vaccine (BNT162b2) will be randomized at 1:1:1 ratio to receive RVM-V001 (30 µg) only, RVM V002 (30 µg) only, or RVM-V001 (15 µg ) + RVM V002 (15 µg ). The last dose of the prior vaccination should have been administered at least 6 months prior to enrolment in this study. For administration of RVM V001 only or RVM V002 only, subjects will receive a single dose of RVM-V001 or RMV-V002 vaccine on Day 1 via intramuscular (IM) injection into deltoid muscle, preferably of the non-dominant arm. For the RVM V001 + RVM V002 administration, subjects will receive a single dose of RVM-V001 in the left arm deltoid muscle and then followed immediately with a single dose of RVM-V002 in the right arm deltoid muscle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
For BNT162b2 subjects
For BNT162b2 subjects
For BNT162b2 subjects
P.H. Feng Research Centre, NCID,TTSH
Singapore, Singapore
Safety in terms of solicited adverse events
Number of subjects with solicited adverse events
Time frame: Day 1 to Day 7 inclusive
Safety in terms of solicited systemic adverse events
Number of subjects with solicited systemic adverse events
Time frame: Day 1 to Day 7 inclusive
Safety in terms of unsolicited adverse events
Number of subjects with unsolicited adverse events
Time frame: Day 1 to Day 28 inclusive
Safety in terms of SAEs, SUSARs, MAAEs and AESIs
Number of subjects with SAEs, SUSARs, MAAEs and AESIs
Time frame: Day 1 to Day 180 post dose
Safety in terms of laboratory-based AEs
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
Immunogenicity in terms of Nab
GMT of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain and BA.1 subvariant
Time frame: Days 1,8,15,29 and 180
GMT of neutralizing antibody (pseudoviral neutralization assay) against Variants of Immunogenicity in terms of Nab
GMT of neutralizing antibody (pseudoviral neutralization assay) against Variants of concerns of SARS-CoV-2
Time frame: Days 1,8,15,29 and 180
Immunogenicity in terms of Humoral immune response by ELISA
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For BBIBP-CorV or CoronaVac subjects
For BBIBP-CorV or CoronaVac subjects
For BBIBP-CorV or CoronaVac subjects
GMT of serum binding antibodies (IgG) by ELISA
Time frame: Days 1,8,15,29 and 180
Seroresponse rate for neutralizing antibody
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Time frame: Days 8,15,29 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 8,15,29 and 180
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Time frame: Days 8,15,29 and 180
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Time frame: Days 8,15,29 and 180