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

NCT05788185 | Terminated Phase 1 DMC

• 1 other identifier: RV003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease; COVID-19

Outcome Measures

Primary Outcomes (5)

• Safety in terms of solicited adverse events

  Number of subjects with solicited adverse events

  Day 1 to Day 7 inclusive

• Safety in terms of solicited systemic adverse events

  Number of subjects with solicited systemic adverse events

  Day 1 to Day 7 inclusive

• Safety in terms of unsolicited adverse events

  Number of subjects with unsolicited adverse events

  Day 1 to Day 28 inclusive

• Safety in terms of SAEs, SUSARs, MAAEs and AESIs

  Number of subjects with SAEs, SUSARs, MAAEs and AESIs

  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.

  Day 1 to Day 180 post dose

Secondary Outcomes (7)

• Immunogenicity in terms of Nab

  Days 1,8,15,29 and 180

• GMT of neutralizing antibody (pseudoviral neutralization assay) against Variants of Immunogenicity in terms of Nab

  Days 1,8,15,29 and 180

• Immunogenicity in terms of Humoral immune response by ELISA

  Days 1,8,15,29 and 180

• Seroresponse rate for neutralizing antibody

  Days 8,15,29 and 180

• Seroresponse rate for binding antibodies (IgG) by ELISA

  Days 8,15,29 and 180

Study Arms (6)

RVM-V001 30 µg -BNT162b2 subjects

EXPERIMENTAL

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

Biological: RVM-V001 30 µg

RVM-V002 30 µg -BNT162b2 subjects

EXPERIMENTAL

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

Biological: RVM-V002 30 µg

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

EXPERIMENTAL

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

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

RVM-V001 30 µg

EXPERIMENTAL

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

Biological: RVM-V001 30 µg

RVM-V002-30 µg

EXPERIMENTAL

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

Biological: RVM-V002 30 µg

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

EXPERIMENTAL

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

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

Interventions

RVM-V001 30 µg BIOLOGICAL

For BNT162b2 subjects

RVM-V001 30 µg -BNT162b2 subjects

RVM-V002 30 µg BIOLOGICAL

For BNT162b2 subjects

RVM-V002 30 µg -BNT162b2 subjects

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

For BNT162b2 subjects

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• RVAC Medicines (US), Inc.: lead

Study Sites (1)

P.H. Feng Research Centre, NCID,TTSH

Singapore, 308443, Singapore

Location

MeSH Terms

Conditions

Communicable Diseases; COVID-19

Interventions

RVM-V001 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 28, 2023
• Study Start: March 22, 2023
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

SG (1)