Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05420077




Registration number
NCT05420077
Ethics application status
Date submitted
7/06/2022
Date registered
15/06/2022
Date last updated
27/06/2023

Titles & IDs
Public title
Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273
Scientific title
Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of RVM-V001 in Healthy Individuals Aged 18-65 Years Previously Vaccinated With BNT162b2 and mRNA-1273
Secondary ID [1] 0 0
RV002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infectious Disease 0 0
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RVM-V001 10 µg
Other interventions - RVM-V001 30 µg
Other interventions - RVM-V001 60 µg

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

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

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


Other interventions: RVM-V001 10 µg
Low Dose

Other interventions: RVM-V001 30 µg
Mid Dose

Other interventions: RVM-V001 60 µg
High Dose
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with solicited adverse events
Timepoint [1] 0 0
Day 1 to Day 8 post dose
Primary outcome [2] 0 0
Number of subjects with solicited systemic adverse events
Timepoint [2] 0 0
Day 1 to Day 8 post dose
Primary outcome [3] 0 0
Number of subjects with unsolicited adverse events
Timepoint [3] 0 0
Day 1 to Day 29 post dose
Primary outcome [4] 0 0
Number of subjects with SAEs, SUSARs, MAAEs and AESIs
Timepoint [4] 0 0
Day 1 to Day 180 post dose
Primary outcome [5] 0 0
Changes in safety laboratory parameters from baseline by the Food and Drug Administration (FDA) toxicity grading scale.
Timepoint [5] 0 0
Day 1 to Day 180 post dose
Primary outcome [6] 0 0
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Timepoint [6] 0 0
Baseline and Day 29
Primary outcome [7] 0 0
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Timepoint [7] 0 0
Baseline and Day 29
Primary outcome [8] 0 0
GMT of serum binding antibodies (IgG) by ELISA
Timepoint [8] 0 0
Baseline and Day 29
Primary outcome [9] 0 0
Seroresponse rate for neutralizing antibody
Timepoint [9] 0 0
Day 29
Primary outcome [10] 0 0
Seroresponse rate for binding antibodies (IgG) by ELISA
Timepoint [10] 0 0
Day 29
Primary outcome [11] 0 0
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Timepoint [11] 0 0
Day 29
Primary outcome [12] 0 0
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Timepoint [12] 0 0
Day 29
Secondary outcome [1] 0 0
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Timepoint [1] 0 0
Days 15 and 180
Secondary outcome [2] 0 0
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Timepoint [2] 0 0
Days 15 and 180
Secondary outcome [3] 0 0
GMT of serum binding antibodies (IgG) by ELISA
Timepoint [3] 0 0
Days 15 and 180
Secondary outcome [4] 0 0
Seroresponse rate for neutralizing antibody
Timepoint [4] 0 0
Days 15 and 180
Secondary outcome [5] 0 0
Seroresponse rate for binding antibodies (IgG) by ELISA
Timepoint [5] 0 0
Days 15 and 180
Secondary outcome [6] 0 0
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Timepoint [6] 0 0
Days 15 and 180
Secondary outcome [7] 0 0
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Timepoint [7] 0 0
Days 15 and 180

Eligibility
Key inclusion criteria
- 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')
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

- Diagnosed with severe liver and kidney diseases, uncontrollable hypertension (systolic
pressure >140 mmHg, diastolic pressure >90 mmHg), diabetic complications, malignant
tumors, acute viral or bacterial infections or acute onset of chronic disease.

- Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma,
leukemia or other autoimmune diseases

- History of coagulation dysfunction (eg, Coagulation factor deficiency, coagulation
disease).

- Vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14
days before vaccination.

- Receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or
infusion for more than 14 days).

- Received systemic immunosuppressants within 4 months prior to vaccination or
anticipating the need for immunosuppressant at any time during participation in the
study. Topical or inhaled treatment is allowed if not used within 14 days prior to
vaccination.

- Receiving blood products within 3 months before administration

- History of alcohol or drug abuse within 3 years before first vaccination.

- Has donated 450ml or greater of blood within 28 days prior to vaccination.

- History of anaphylaxis or angioedema including but not limited to history of
anaphylaxis after any vaccine.

- Any condition that, in the opinion of the investigator, would pose a health risk to
the subject if enrolled or could interfere with evaluation of the study vaccine or has
interpretation of study results (including neurologic or psychiatric conditions deemed
likely to impair the quality of safety reporting).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/06/2023
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [2] 0 0
Core Research Group Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
4064 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
RVAC Medicines (US), Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05420077
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05420077