AzTrials
AzTrials

Infectious DiseasePhase 1/2NCT05788185

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

A Phase 1/2 study testing RVM-V001 30 µg, RVM-V002 30 µg and RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration in people with Infectious Disease and COVID-19, run by RVAC Medicines (US), Inc. at 1 site in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Infectious Disease, COVID-19
What is being tested?
RVM-V001 30 µg, RVM-V002 30 µg and RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSingapore
Study dates
22 Mar 2023to 21 Sep 2023
Phase
Phase 1/2
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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • P.H. Feng Research Centre, NCID,TTSH

    Singapore, 308443

Other trials in Singapore

About this study

Official title: 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 Previously Vaccinated With an Inactivated Virus or mRNA-based COVID-19 Vaccine in Singapore

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.

Read the detailed description

A total of 48 healthy men and non-pregnant women aged 21 years and older will be stratified by prior vaccination. Twenty-four subjects who have received a 3 dose primary vaccination series, with or without 1 booster dose, of an approved inactivated virus vaccine (BBIBP-CorV or CoronaVac) will be randomized at a 1:1:1 ratio to receive RVM V001 (30 µg) only, RVM V002 (30 µg) only, or RVM-V001 (15 µg) + RVM V002 (15ug).

An additional 24 subjects who have received 3 doses (primary vaccination series and 1 booster dose) of an mRNA vaccine (BNT162b2) will be randomized at 1:1:1 ratio to receive RVM-V001 (30 µg) only, RVM V002 (30 µg) only, or RVM-V001 (15 µg ) + RVM V002 (15 µg ). The last dose of the prior vaccination should have been administered at least 6 months prior to enrolment in this study. For administration of RVM V001 only or RVM V002 only, subjects will receive a single dose of RVM-V001 or RMV-V002 vaccine on Day 1 via intramuscular (IM) injection into deltoid muscle, preferably of the non-dominant arm.

For the RVM V001 + RVM V002 administration, subjects will receive 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.

Being tested
RVM-V001 30 µg, RVM-V002 30 µg, RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
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 30 µgBiological

    For BNT162b2 subjects

  • RVM-V002 30 µgBiological

    For BNT162b2 subjects

  • RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administrationBiological

    For BNT162b2 subjects

  • RVM-V001 30 µgBiological

    For BBIBP-CorV or CoronaVac subjects

  • RVM-V002 30 µgBiological

    For BBIBP-CorV or CoronaVac subjects

  • RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administrationBiological

    For BBIBP-CorV or CoronaVac subjects

Study groups in NCT05788185
Study groupRoleWhat they receive
RVM-V001 30 µg -BNT162b2 subjectsExperimentalRVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BNT162b2 subjects
Receives: Biological: RVM-V001 30 µg
RVM-V002 30 µg -BNT162b2 subjectsExperimentalRVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BNT162b2 subjects
Receives: Biological: RVM-V002 30 µg
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration -BNT162b2 subjectsExperimentalRVM-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
Receives: Biological: RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
RVM-V001 30 µgExperimentalRVM-V001-30 µg administered as a single dose of by intramuscular injection on Day 1 on BBIBP-CorV or CoronaVac subjects
Receives: Biological: RVM-V001 30 µg
RVM-V002-30 µgExperimentalRVM-V002-30 µg administered as a single dose of by intramuscular injection on Day 1 on BBIBP-CorV or CoronaVac subjects
Receives: Biological: RVM-V002 30 µg
RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administrationExperimentalRVM-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
Receives: Biological: RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety in terms of solicited adverse events

    Number of subjects with solicited adverse events

    Measured: Day 1 to Day 7 inclusive

  2. Safety in terms of solicited systemic adverse events

    Number of subjects with solicited systemic adverse events

    Measured: Day 1 to Day 7 inclusive

  3. Safety in terms of unsolicited adverse events

    Number of subjects with unsolicited adverse events

    Measured: Day 1 to Day 28 inclusive

  4. Safety in terms of SAEs, SUSARs, MAAEs and AESIs

    Number of subjects with SAEs, SUSARs, MAAEs and AESIs

    Measured: Day 1 to Day 180 post dose

  5. Safety in terms of laboratory-based AEs

    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

Secondary outcomes (7)

  1. Immunogenicity in terms of Nab

    GMT of neutralizing antibody (pseudoviral neutralization assay) against Wuhan strain and BA.1 subvariant

    Measured: Days 1,8,15,29 and 180

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

    GMT of neutralizing antibody (pseudoviral neutralization assay) against Variants of concerns of SARS-CoV-2

    Measured: Days 1,8,15,29 and 180

  3. Immunogenicity in terms of Humoral immune response by ELISA

    GMT of serum binding antibodies (IgG) by ELISA

    Measured: Days 1,8,15,29 and 180

  4. Seroresponse rate for neutralizing antibody

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

    Measured: Days 8,15,29 and 180

  5. Seroresponse rate for binding antibodies (IgG) by ELISA

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

    Measured: Days 8,15,29 and 180

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

    Measured: Days 8,15,29 and 180

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

    Measured: Days 8,15,29 and 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start22 Mar 2023
  3. Primary completion21 Sep 2023
  4. Study completion21 Sep 2023

Why it stopped: Changes in COVID-19 pandemic landscape

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05788185
Sponsor's protocol ID
RV003
Status last verified
Oct 2023
First submitted
21 Feb 2023
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RVM-V001 30 µg, RVM-V002 30 µg and RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration in people with Infectious Disease and COVID-19, run by RVAC Medicines (US), Inc. at 1 site in Singapore.

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 7 inclusion and 13 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: Changes in COVID-19 pandemic landscape). 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?

Safety in terms of solicited adverse events (time frame: Day 1 to Day 7 inclusive). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05788185.

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 16 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in