NCT05788185

Safety & Immunogenicity of RVM-V001/RVM-V002 or RVMV001+RVMV002 (Co Administered as Separate Injections) in Healthy Individuals

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 Previously Vaccinated With an Inactivated Virus or mRNA-based COVID-19 Vaccine in Singapore

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: RVAC Medicines (US), Inc. · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Infectious Disease
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	RVM-V001 30 µg	For BNT162b2 subjects
BIOLOGICAL	RVM-V002 30 µg	For BNT162b2 subjects
BIOLOGICAL	RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration	For BNT162b2 subjects
BIOLOGICAL	RVM-V001 30 µg	For BBIBP-CorV or CoronaVac subjects
BIOLOGICAL	RVM-V002 30 µg	For BBIBP-CorV or CoronaVac subjects
BIOLOGICAL	RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration	For BBIBP-CorV or CoronaVac subjects

Timeline

• Start date: 2023-03-22
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2023-03-28
• Last updated: 2023-10-16

Locations

1 site across 1 country: Singapore