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

Primary Purpose

Infectious Disease, COVID-19

Status
Terminated
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
RVM-V001 30 µg
RVM-V002 30 µg
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
RVM-V001 30 µg
RVM-V002 30 µg
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
Sponsored by
RVAC Medicines (US), Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female healthy volunteers. Aged 21 years and older on Day 1 Judged by the investigator to be healthy based on medical history, physical examination, and vital signs evaluation at Screening visit. Able to provide informed consent form. Able and willing to comply with all study procedures over follow-up period of approximately 6 months. Have documented completion of a 2-dose primary vaccination series and 1 booster vaccination with BNT162b2 OR a 3-dose primary vaccination series, with or without 1 booster dose, with an approved inactivated virus vaccine (BBIBP-CorV or CoronaVac). The last dose in all cases should have been administered at least 6 months prior to enrolment in this study. For female subjects with childbearing potential: must agree to avoid pregnancy from 21 days prior to Day 1 until at least 90 days after the last study vaccination. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Exclusion Criteria: Received any COVID-19 vaccine other than BNT162b2, BBIBP-CorV, or CoronaVac. Received more than 3 doses of BNT162b2 or more than 4 doses of BBIBP-CorV or CoronaVac. Women who are pregnant or breastfeeding or intending to become pregnant; mend who will father children within the projected duration of the trial. Positive serology test results for hepatitis C virus antibody, human immunodeficiency virus antibody, or hepatitis B viral surface antigen at Screening. Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 1. History of severe allergic reactions (eg, acute anaphylaxis, urticaria, skin eczema, dyspnoea, angioneurotic oedema) or other significant adverse reactions to COVID19 vaccines; allergy to known composition of RVM-001 and RVM-002. History of coagulation dysfunction (eg, coagulation factor deficiency, coagulation disease). Vaccinated with live attenuated vaccine within 1 month, or any other vaccine within 14 days, of Day 1 vaccination. Received systemic immunosuppressants within 4 months prior to vaccination or an anticipated need for immunosuppressants at any time during the study. Topical or inhaled treatment is allowed if not used within 14 days prior to Day 1 vaccination. Received blood products within 3 months prior to Day 1 vaccination. History of alcohol or drug abuse within 3 years prior to Day 1 vaccination. Fever (temperature > 37.5°C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhoea, shortness of breath, or dyspnoea on the day of vaccination. Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled, could interfere with the evaluation of the study vaccine, or interfere with interpretation of the study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).

Sites / Locations

  • P.H. Feng Research Centre, NCID,TTSH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

RVM-V001 30 µg -BNT162b2 subjects

RVM-V002 30 µg -BNT162b2 subjects

RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration -BNT162b2 subjects

RVM-V001 30 µg

RVM-V002-30 µg

RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration

Arm Description

RVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BNT162b2 subjects

RVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BNT162b2 subjects

RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration; 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 on Day 1 on BNT162b2 subjects

RVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BBIBP-CorV or CoronaVac subjects

RVM-V002-30 µg administered as a single dose of by intramuscular injection on Day 1 on BBIBP-CorV or CoronaVac subjects

RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration; 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 on Day 1 on BBIBP-CorV or CoronaVac subjects

Outcomes

Primary Outcome Measures

Safety in terms of solicited adverse events
Number of subjects with solicited adverse events
Safety in terms of solicited systemic adverse events
Number of subjects with solicited systemic adverse events
Safety in terms of unsolicited adverse events
Number of subjects with unsolicited adverse events
Safety in terms of SAEs, SUSARs, MAAEs and AESIs
Number of subjects with SAEs, SUSARs, MAAEs and AESIs
Safety in terms of laboratory-based AEs
Changes in safety laboratory parameters from baseline by the Food and Drug Administration (FDA) toxicity grading scale.

Secondary Outcome Measures

Immunogenicity in terms of Nab
GMT of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain and BA.1 subvariant
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
Immunogenicity in terms of Humoral immune response by ELISA
GMT of serum binding antibodies (IgG) by ELISA
Seroresponse rate for neutralizing antibody
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Seroresponse rate for binding antibodies (IgG) by ELISA
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA

Full Information

First Posted
February 21, 2023
Last Updated
October 13, 2023
Sponsor
RVAC Medicines (US), Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05788185
Brief Title
Safety & Immunogenicity of RVM-V001/RVM-V002 or RVMV001+RVMV002 (Co Administered as Separate Injections) in Healthy Individuals
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Changes in COVID-19 pandemic landscape
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
September 21, 2023 (Actual)
Study Completion Date
September 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RVAC Medicines (US), Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease, COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RVM-V001 30 µg -BNT162b2 subjects
Arm Type
Experimental
Arm Description
RVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BNT162b2 subjects
Arm Title
RVM-V002 30 µg -BNT162b2 subjects
Arm Type
Experimental
Arm Description
RVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BNT162b2 subjects
Arm Title
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration -BNT162b2 subjects
Arm Type
Experimental
Arm Description
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration; 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 on Day 1 on BNT162b2 subjects
Arm Title
RVM-V001 30 µg
Arm Type
Experimental
Arm Description
RVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BBIBP-CorV or CoronaVac subjects
Arm Title
RVM-V002-30 µg
Arm Type
Experimental
Arm Description
RVM-V002-30 µg administered as a single dose of by intramuscular injection on Day 1 on BBIBP-CorV or CoronaVac subjects
Arm Title
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
Arm Type
Experimental
Arm Description
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration; 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 on Day 1 on BBIBP-CorV or CoronaVac subjects
Intervention Type
Biological
Intervention Name(s)
RVM-V001 30 µg
Intervention Description
For BNT162b2 subjects
Intervention Type
Biological
Intervention Name(s)
RVM-V002 30 µg
Intervention Description
For BNT162b2 subjects
Intervention Type
Biological
Intervention Name(s)
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
Intervention Description
For BNT162b2 subjects
Intervention Type
Biological
Intervention Name(s)
RVM-V001 30 µg
Intervention Description
For BBIBP-CorV or CoronaVac subjects
Intervention Type
Biological
Intervention Name(s)
RVM-V002 30 µg
Intervention Description
For BBIBP-CorV or CoronaVac subjects
Intervention Type
Biological
Intervention Name(s)
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
Intervention Description
For BBIBP-CorV or CoronaVac subjects
Primary Outcome Measure Information:
Title
Safety in terms of solicited adverse events
Description
Number of subjects with solicited adverse events
Time Frame
Day 1 to Day 7 inclusive
Title
Safety in terms of solicited systemic adverse events
Description
Number of subjects with solicited systemic adverse events
Time Frame
Day 1 to Day 7 inclusive
Title
Safety in terms of unsolicited adverse events
Description
Number of subjects with unsolicited adverse events
Time Frame
Day 1 to Day 28 inclusive
Title
Safety in terms of SAEs, SUSARs, MAAEs and AESIs
Description
Number of subjects with SAEs, SUSARs, MAAEs and AESIs
Time Frame
Day 1 to Day 180 post dose
Title
Safety in terms of laboratory-based AEs
Description
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
Secondary Outcome Measure Information:
Title
Immunogenicity in terms of Nab
Description
GMT of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain and BA.1 subvariant
Time Frame
Days 1,8,15,29 and 180
Title
GMT of neutralizing antibody (pseudoviral neutralization assay) against Variants of Immunogenicity in terms of Nab
Description
GMT of neutralizing antibody (pseudoviral neutralization assay) against Variants of concerns of SARS-CoV-2
Time Frame
Days 1,8,15,29 and 180
Title
Immunogenicity in terms of Humoral immune response by ELISA
Description
GMT of serum binding antibodies (IgG) by ELISA
Time Frame
Days 1,8,15,29 and 180
Title
Seroresponse rate for neutralizing antibody
Description
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Time Frame
Days 8,15,29 and 180
Title
Seroresponse rate for binding antibodies (IgG) by ELISA
Description
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Time Frame
Days 8,15,29 and 180
Title
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Time Frame
Days 8,15,29 and 180
Title
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Time Frame
Days 8,15,29 and 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female healthy volunteers. Aged 21 years and older on Day 1 Judged by the investigator to be healthy based on medical history, physical examination, and vital signs evaluation at Screening visit. Able to provide informed consent form. Able and willing to comply with all study procedures over follow-up period of approximately 6 months. Have documented completion of a 2-dose primary vaccination series and 1 booster vaccination with BNT162b2 OR a 3-dose primary vaccination series, with or without 1 booster dose, with an approved inactivated virus vaccine (BBIBP-CorV or CoronaVac). The last dose in all cases should have been administered at least 6 months prior to enrolment in this study. For female subjects with childbearing potential: must agree to avoid pregnancy from 21 days prior to Day 1 until at least 90 days after the last study vaccination. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Exclusion Criteria: Received any COVID-19 vaccine other than BNT162b2, BBIBP-CorV, or CoronaVac. Received more than 3 doses of BNT162b2 or more than 4 doses of BBIBP-CorV or CoronaVac. Women who are pregnant or breastfeeding or intending to become pregnant; mend who will father children within the projected duration of the trial. Positive serology test results for hepatitis C virus antibody, human immunodeficiency virus antibody, or hepatitis B viral surface antigen at Screening. Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 1. History of severe allergic reactions (eg, acute anaphylaxis, urticaria, skin eczema, dyspnoea, angioneurotic oedema) or other significant adverse reactions to COVID19 vaccines; allergy to known composition of RVM-001 and RVM-002. History of coagulation dysfunction (eg, coagulation factor deficiency, coagulation disease). Vaccinated with live attenuated vaccine within 1 month, or any other vaccine within 14 days, of Day 1 vaccination. Received systemic immunosuppressants within 4 months prior to vaccination or an anticipated need for immunosuppressants at any time during the study. Topical or inhaled treatment is allowed if not used within 14 days prior to Day 1 vaccination. Received blood products within 3 months prior to Day 1 vaccination. History of alcohol or drug abuse within 3 years prior to Day 1 vaccination. Fever (temperature > 37.5°C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhoea, shortness of breath, or dyspnoea on the day of vaccination. Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled, could interfere with the evaluation of the study vaccine, or interfere with interpretation of the study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
Facility Information:
Facility Name
P.H. Feng Research Centre, NCID,TTSH
City
Singapore
ZIP/Postal Code
308443
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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