Trial Review

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Trial details imported from ClinicalTrials.gov

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: RVM-V001 10 µg - RVM-V001-10 µg administered as a single dose of by intramuscular injection on Day 1
Comparator / control treatment
Control group

Outcomes

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
Stopped early
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)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05420077