Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273

NCT05420077 | Terminated Phase 1 DMC

• 1 other identifier: RV002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infectious Disease; COVID-19

Outcome Measures

Primary Outcomes (12)

• Number of subjects with solicited adverse events

  Day 1 to Day 8 post dose

• Number of subjects with solicited systemic adverse events

  Day 1 to Day 8 post dose

• Number of subjects with unsolicited adverse events

  Day 1 to Day 29 post dose

• Number of subjects with SAEs, SUSARs, MAAEs and AESIs

  Day 1 to Day 180 post dose

• Changes in safety laboratory parameters from baseline by the Food and Drug Administration (FDA) toxicity grading scale.

  Day 1 to Day 180 post dose

• GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain

  Baseline and Day 29

• GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2

  Baseline and Day 29

• GMT of serum binding antibodies (IgG) by ELISA

  Baseline and Day 29

• Seroresponse rate for neutralizing antibody

  SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline

  Day 29

• Seroresponse rate for binding antibodies (IgG) by ELISA

  SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline

  Day 29

• Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody

  Day 29

• Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA

  Day 29

Secondary Outcomes (7)

• GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain

  Days 15 and 180

• GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2

  Days 15 and 180

• GMT of serum binding antibodies (IgG) by ELISA

  Days 15 and 180

• Seroresponse rate for neutralizing antibody

  Days 15 and 180

• Seroresponse rate for binding antibodies (IgG) by ELISA

  Days 15 and 180

Study Arms (3)

RVM-V001 10 µg

EXPERIMENTAL

RVM-V001-10 µg administered as a single dose of by intramuscular injection on Day 1

Biological: RVM-V001 10 µg

RVM-V001 30 µg

EXPERIMENTAL

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

Biological: RVM-V001 30 µg

RVM-V001 60 µg

EXPERIMENTAL

RVM-V001-60 µg administered as a single dose of by intramuscular injection on Day 1

Biological: RVM-V001 60 µg

Interventions

RVM-V001 10 µg BIOLOGICAL

Low Dose

RVM-V001 10 µg

RVM-V001 30 µg BIOLOGICAL

Mid Dose

RVM-V001 30 µg

RVM-V001 60 µg BIOLOGICAL

High Dose

RVM-V001 60 µg

Eligibility Criteria

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

You may qualify if:

• Male and female healthy volunteers.
• Is age 18 and 65 years inclusive on Study Day 1.
• Judged by the investigator to be healthy based on medical history, physical examination, vital signs, and no significant electrocardiogram (ECG) abnormalities performed at screening.
• Able to provide informed consent form.
• Able and willing to comply with all study procedures over follow-up period of approximately 6 months.
• 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.
• Body mass index of 18-32 kg/m2, inclusive, at screening.
• For female subjects with childbearing potential: must agree to avoid pregnancy from 21 days prior to Study Day 1 until at least 90 days after 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. Acceptable methods of avoiding pregnancy include a sterile sexual partner, hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm.
• Men must be willing to refrain from sperm donation, starting after screening until 90 days after receiving the last vaccination.
• Male and female subjects must use a barrier method of contraception, from 21 days prior to Study Day 1 until at least 90 days after last study vaccination. Barrier methods of contraception include:
• Male condoms
• Female condoms
• Female diaphragm ('cap')

You may not qualify if:

• Documented history of COVID-19 within 6 months prior to enrollment.
• Positive reverse transcription - polymerase chain reaction (RT-PCR) test for SARS-CoV-2 within 2 days of screening
• Received any COVID-19 vaccine other than BNT162b2 or mRNA-1273.
• Received more than 3 doses of any mRNA COVID-19 vaccine.
• Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial.
• Currently working in an occupation with a high risk of exposure to SARS-CoV-2 (eg, Healthcare worker, emergency response personnel having direct interactions with or providing direct care to patients).
• History of infection of Middle East respiratory syndrome (MERS), or Severe Acute respiratory syndrome (SARS).
• Positive serology test results for hepatitis C virus antibody, HIV antibody, hepatitis B virus surface antigen at Screening.
• Currently taking marketed, investigational, off-label product for the prevention of MERS, SARS, or COVID-19.
• Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 1.
• Fever (tympanic temperature \> 37.5 degree C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath or dyspnea within 14 days before administration
• Abnormal indicators, such as blood biochemistry, blood routine and urine routine deemed clinically significant by the investigator, or the value is beyond Grade 1 per toxicity grading scale.
• History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of RVM-V001 vaccine.
• History of convulsion, epilepsy, encephalopathy or severe mental illness.
• Diagnosed with congenital malformations or developmental disorders, genetic defects, severe malnutrition.

Sponsors & Collaborators

• RVAC Medicines (US), Inc.: lead

Study Sites (2)

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Core Research Group Pty Ltd

Brisbane, Queensland, 4064, Australia

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: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 15, 2022
• Study Start: September 12, 2022
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

AU (2)