Infectious DiseasePhase 1NCT05420077
Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273
A Phase 1 study testing RVM-V001 10 µg, RVM-V001 30 µg and RVM-V001 60 µg in people with Infectious Disease and COVID-19, run by RVAC Medicines (US), Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, COVID-19
- What is being tested?
- RVM-V001 10 µg, RVM-V001 30 µg and RVM-V001 60 µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesAustralia
- Study dates
- 12 Sep 2022to 2 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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')
Who cannot join
- 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).
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- 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).
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Core Research Group Pty Ltd
Brisbane, Queensland, 4064
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
About this study
Official 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
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.
Read the detailed description
Approximately 54 healthy non-pregnant female and male adults aged 18-65 years inclusive are planned to be enrolled in the study. All subjects will 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.
This study is composed of 3 dose groups, Groups 1, 2 and 3 per dose level. 18 eligible subjects in each dose group will receive RVM-V001 on Study Day 1 via intramuscular (IM) injection into deltoid muscle of the non-dominant arm.
Subjects will be sequentially assigned to a dose group beginning with Group 1 (10 µg RVM-V001) based on the timing of completion of screening. As a precautionary step, 3 sentinel subjects, at least one male and one female will be used within each dose group. Enrollment of each dose group will start with the 3 sentinel subjects. After at least 2 days from the time of study vaccine administration of the 3 sentinel subjects, the 2-day safety data will be collected and reviewed by the principal investigator and local medical monitor. Should there be no safety concerns, the remaining subjects in the same dose group can be enrolled.
- Conditions
- Infectious Disease, COVID-19
- Being tested
- RVM-V001 10 µg, RVM-V001 30 µg, RVM-V001 60 µg
- Medical subject headings
- Communicable Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVM-V001 10 µgBiological
Low Dose
RVM-V001 30 µgBiological
Mid Dose
RVM-V001 60 µgBiological
High Dose
| Study group | Role | What they receive |
|---|---|---|
| RVM-V001 10 µg | Experimental | RVM-V001-10 µg administered as a single dose of by intramuscular injection on Day 1 Receives: 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 Receives: 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 Receives: Biological: RVM-V001 60 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with solicited adverse events
Measured: Day 1 to Day 8 post dose
Number of subjects with solicited systemic adverse events
Measured: Day 1 to Day 8 post dose
Number of subjects with unsolicited adverse events
Measured: Day 1 to Day 29 post dose
Number of subjects with SAEs, SUSARs, MAAEs and AESIs
Measured: Day 1 to Day 180 post dose
Changes in safety laboratory parameters from baseline by the Food and Drug Administration (FDA) toxicity grading scale.
Measured: Day 1 to Day 180 post dose
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Measured: Baseline and Day 29
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Measured: Baseline and Day 29
GMT of serum binding antibodies (IgG) by ELISA
Measured: Baseline and Day 29
Seroresponse rate for neutralizing antibody
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Measured: Day 29
Seroresponse rate for binding antibodies (IgG) by ELISA
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Measured: Day 29
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Measured: Day 29
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Measured: Day 29
Secondary outcomes (7)
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Measured: Days 15 and 180
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Measured: Days 15 and 180
GMT of serum binding antibodies (IgG) by ELISA
Measured: Days 15 and 180
Seroresponse rate for neutralizing antibody
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Measured: Days 15 and 180
Seroresponse rate for binding antibodies (IgG) by ELISA
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Measured: Days 15 and 180
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Measured: Days 15 and 180
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Measured: Days 15 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start12 Sep 2022
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Why it stopped: The landscape of the study area changed, making it impossible to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- RVAC Medicines (US), Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420077
- Sponsor's protocol ID
- RV002
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2022
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05420077
- Acronym / sponsor ID
- RV002
- Conditions
- Infectious Disease, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The landscape of the study area changed, making it impossible to continue the study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- RVAC Medicines (US), Inc.University, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 54 healthy non-pregnant female and male adults aged 18-65 years inclusive are planned to be enrolled in the study. All subjects will 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.
This study is composed of 3 dose groups, Groups 1, 2 and 3 per dose level. 18 eligible subjects in each dose group will receive RVM-V001 on Study Day 1 via intramuscular (IM) injection into deltoid muscle of the non-dominant arm.
Subjects will be sequentially assigned to a dose group beginning with Group 1 (10 µg RVM-V001) based on the timing of completion of screening. As a precautionary step, 3 sentinel subjects, at least one male and one female will be used within each dose group. Enrollment of each dose group will start with the 3 sentinel subjects. After at least 2 days from the time of study vaccine administration of the 3 sentinel subjects, the 2-day safety data will be collected and reviewed by the principal investigator and local medical monitor. Should there be no safety concerns, the remaining subjects in the same dose group can be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RVM-V001 10 µg | Experimental | Biological: RVM-V001 10 µgRVM-V001-10 µg administered as a single dose of by intramuscular injection on Day 1 |
| RVM-V001 30 µg | Experimental | Biological: RVM-V001 30 µgRVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 |
| RVM-V001 60 µg | Experimental | Biological: RVM-V001 60 µgRVM-V001-60 µg administered as a single dose of by intramuscular injection on Day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVM-V001 10 µgLow Dose | Biological | RVM-V001 10 µg |
| RVM-V001 30 µgMid Dose | Biological | RVM-V001 30 µg |
| RVM-V001 60 µgHigh Dose | Biological | RVM-V001 60 µg |
Primary outcome
Number of subjects with solicited adverse events
Time frame: Day 1 to Day 8 post dose
Number of subjects with solicited systemic adverse events
Time frame: Day 1 to Day 8 post dose
Number of subjects with unsolicited adverse events
Time frame: Day 1 to Day 29 post dose
Number of subjects with SAEs, SUSARs, MAAEs and AESIs
Time frame: Day 1 to Day 180 post dose
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
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Time frame: Baseline and Day 29
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Time frame: Baseline and Day 29
GMT of serum binding antibodies (IgG) by ELISA
Time frame: Baseline and Day 29
Seroresponse rate for neutralizing antibody
Time frame: Day 29
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Seroresponse rate for binding antibodies (IgG) by ELISA
Time frame: Day 29
SRR percentage of subjects with ≥4-fold increase of antibody titer over baseline
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Time frame: Day 29
7 secondary outcomes
GMT of of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain
Time frame: Days 15 and 180
GMT of neutralizing antibody (pseudoviral neutralization assay) against Omicron and Delta variants of SARS-CoV-2
Time frame: Days 15 and 180
GMT of serum binding antibodies (IgG) by ELISA
Time frame: Days 15 and 180
Seroresponse rate for neutralizing antibody
Time frame: Days 15 and 180
Seroresponse rate for binding antibodies (IgG) by ELISA
Time frame: Days 15 and 180
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody
Time frame: Days 15 and 180
Geometric Mean Fold Rise (GMFR) of binding antibodies (IgG) by ELISA
Time frame: Days 15 and 180
Results and safety
The study was stopped early (reason given: The landscape of the study area changed, making it impossible to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RVM-V001 10 µg, RVM-V001 30 µg and RVM-V001 60 µg in people with Infectious Disease and COVID-19, run by RVAC Medicines (US), Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The landscape of the study area changed, making it impossible to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with solicited adverse events (time frame: Day 1 to Day 8 post dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.