COVID-19 VaccinePhase 1NCT05656508
ARVAC - A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine
A Phase 1 study testing ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) in people with COVID-19 Vaccine, run by Laboratorio Pablo Cassara S.R.L. at 1 site in Argentina.
Trial summary
The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 (ARVAC-CG) in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus. The main questions it aims to answer are: What is the safety and tolerability profile of the two-dose schedule of this new vaccine? What is the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine
- What is being tested?
- ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Apr 2022to 29 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants between 18 and 55 years of age
- With the ability and willingness to comply with the prohibitions and restrictions specified in the protocol.
- Healthy volunteers, which will be determined by the history referred to interrogation, physical examination, and principal investigator's criteria.
- In fertile female volunteers, negative pregnancy test at the beginning of the study and commitment to use a contraceptive method from the date of signing the consent form until 3 months after vaccine study application. Use of a hormonal contraceptive method must begin at least 28 days prior to study vaccine application. The investigator should assess potential contraceptive method failure (e.g. non-compliance, recent onset) in relation to vaccination. Acceptable effective methods for this study include:
- hormonal contraceptive method: i) combined (containing estrogen and progestin) associated with the inhibition of ovulation (oral, intravaginal or transdermal); ii) with progestin only, associated with the inhibition of ovulation (oral, injectable or implantable); b) intrauterine device;. c) intrauterine hormone release system; d) bilateral tubal ligation/occlusion procedure; e) single couple with vasectomy; f) sexual abstinence, which will be considered effective only if it is defined as abstaining from heterosexual relations from the date of signing the consent until 3 months after receiving the study vaccine. The reliability of sexual abstinence should be assessed in relation to the duration of the study and the participant's usual and preferred lifestyle.
- Participant who agrees to do not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine;
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- Participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of COVID-19 surveillance;
- Negative PCR for the SARS-CoV-2 virus.
- With laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the study vaccine, which must include:
- complete cell blood count (hemoglobin (Hb), leukocyte count and leukocyte formula, platelet count;
- complete liver test: total and direct bilirubin, alanine aminotransaminases (ALT) and aspartate aminotransferase (AST), lactate dehydrogenase (LDH), alkaline phosphatase (ALF).
- biochemistry: glycemia, urea, creatinine;
- Qualitative C-reactive protein (PCR);
- Complete urine.
- Capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.
Who cannot join
- History of SARS-CoV-2 infection or known previous disease, within 60 days prior to study entry (at least 60 days from epidemiological discharge).
- Administration of any other commercial vaccine or not, based on:
- Live attenuated virus within 28 days prior to study entry.
- Killed virus within 14 days prior to study entry.
- Individuals that have not received a complete primary vaccination schedule against SARS-CoV-2 virus (1 or 2 doses, depending on the vaccine used in the primary schedule).
- Administration of complete primary vaccination schedule against SARS-CoV-2 virus (1 or 2 doses, depending on the vaccine received), within 4 months prior to the start of the study.
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- Administration of an additional or booster dose after a complete primary vaccination schedule against SARS-CoV-2 virus.
- Individuals that have scheduled to receive any other commercial vaccine in the following 3 months.
- Individuals that have participated in a research study within 60 days prior to the start of the study.
- History of known allergies or a history of anaphylaxis or any other serious adverse reaction with other vaccines or their excipients.
- History of alcoholism or substance abuse that prevents compliance with the characteristics of the protocol.
- Acute infectious disease at enrollment (this does not include minor conditions such as diarrhea or mild upper respiratory tract illness) or temperature ≥38. 0°C within 24 hours prior to scheduled study vaccination; later admission is permitted at the discretion of the investigator and after the Sponsor agreement.
- Any laboratory determination alteration with a degree of severity > 1 according to the Common Toxicity Criteria (CTC version 5 - November 2017). Participants with any stable grade 1 abnormality may be considered eligible by the investigator. (grade 1 stable implies a repetition of the sample that persists with an alteration of one grade no greater than 1).
- Body Mass Index (BMI) greater than 30 kg/m2 or less than 18 kg/m2.
- Individuals currently working in occupations with high exposure to SARS-CoV-2.
- History of any clinical condition that affects the function of the immune system, including, but not limited to:
- Clinical conditions (e.g. autoimmune disease or possibly immune-mediated disease or known or suspected immunodeficiency; diabetes mellitus type I or II, chronic kidney disease, etc.).
- Chronic or recurrent use of systemic corticosteroids in the 6 months prior to study vaccine administration and during the study. A substantially immunosuppressive dose of steroids is considered ≥2 weeks of daily administration of 20 mg prednisone or equivalent.
- Administration of antineoplastic and immunomodulatory agents or radiation therapy within 6 months prior to study vaccine administration or during the study.
- The volunteer has received an investigational drug (including drugs related to COVID-19 prophylaxis) or used an investigational invasive medical device in the past 30 days or has received investigational immunoglobulin or monoclonal antibodies within 3 months (participation in an observational study is allowed at the discretion of the investigator, previously informing the Sponsor about this decision).
- The participant is pregnant, plans to become pregnant within 3 months after the administration of the vaccine, or is in postpartum or lactation period.
- The volunteer has any contraindication to receive intramuscular injections and/or blood draws.
- The volunteer has a history of acute polyneuropathy (e.g. Guillain Barré syndrome).
- The volunteer underwent a surgical procedure that required hospitalization (defined as hospitalization for more than 24 hours or overnight hospitalization), in the 12 weeks prior to vaccination, or has not recovered completely from surgery that required hospitalization or is scheduled for surgery that will require hospitalization during the time he/she is expected to participate in the study or within 6 months of study vaccine administration.
- Positive serology for hepatitis (Hepatitis B surface antigen [HBsAg], Hepatitis B core antigen antibodies [Anti-HBc], Hepatitis C virus antibodies [Anti-HCV]).
- Positive antibodies against Human Immunodeficiency Virus (HIV).
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Unidad de Investigación Clínica Farmacocinética FP Clinical Pharma en Clínica CIAREC
Buenos Aires, C1431CAF
About this study
Official title: Phase 1 Study to Evaluate Safety, Tolerability and Immunogenicity of a New Recombinant Protein-based Vaccine (ARVAC CG) Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), in a Population of Healthy Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.
The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 (ARVAC-CG) in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus.
The main questions it aims to answer are:
- What is the safety and tolerability profile of the two-dose schedule of this new vaccine?
- What is the immune response after each dose of vaccine Participants will receive two doses of the study vaccine 28 days apart. They will be required to complete a total of 7 safety and immunogenicity follow-up visits over a 1-year period.
- Conditions
- COVID-19 Vaccine
- Being tested
- ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)Biological
2 doses of vaccine with an interval between doses of 28 days. Administration route: Intramuscular (IM) injection
| Study group | Role | What they receive |
|---|---|---|
| 25 µg of antigen | Experimental | Volunteers will receive 2 doses of ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) of 25 µg of antigen, separated by 28 days Receives: Biological: ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) |
| 50 µg of antigen | Experimental | Volunteers will receive 2 doses of ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) of 50 µg of antigen, separated by 28 days Receives: Biological: ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Solicited local and systemic reactions after administration of each dose of the vaccine.
Number of volunteers overall and in each dose group with local or systemic vaccine reactogenicity, based on evaluation of solicited adverse events (AEs) recorded on subject memory aids or during clinical assessments
Measured: Day 0 to 7 after each vaccination
Safety: Unsolicited adverse events after each vaccine dose
Number of volunteers overall and in each dose group with unsolicited vaccine-associated adverse events (AEs) in each dose group
Measured: Day 0 to 30 after each vaccination
Safety: Serious adverse events
Number of volunteers overall and in each dose group with vaccine-associated serious adverse events (SAEs)
Measured: Day 0 to 30 after each vaccination
Safety: Variations in the laboratory results
Number of volunteers overall and in each dose group with variations in laboratory results from a baseline control at days 7, 28 and 56.
Measured: Day 0 to 56 after vaccination
Secondary outcomes (3)
Immunogenicity: Neutralizing antibodies
Geometric Mean Title (GMT) at baseline, 14 days and 28 days after each dose
Measured: Day 0 to 28 days after each vaccine dose
Immunogenicity: Total specific antibodies
Geometric Mean Title (GMT) at baseline and 28 days after each dose
Measured: Day 0 to 28 days after each vaccine dose
Immunogenicity: Number of Inteferon (IFN) gamma and interleukin (IL)-4 producing cells directed to Receptor Binding Domain (RBD) (Spike protein region)
Determination of cellular immune response, specific IFN gamma and IL-4 producing cells directed to RBD (Spike protein region) on day 1 (prior to the first dose) and 28 days after each vaccine dose
Measured: Day 0 to 28 days after each vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start20 Apr 2022
- Primary completion30 Sep 2022
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccineStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- The volunteers will be divided into 2 arms: Group 1 will receive a vaccination schedule of 2 doses of 25 µg of antigen Group 2 will receive a vaccination schedule of 2 doses of 50 µg of antigen
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Pablo Cassara S.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Nacional de San Martín (UNSAM), National Council of Scientific and Technical Research, Argentina
- Responsible party
- Sponsor
- Investigators
- Gustavo A YERINO, MD., Principal investigator, Unidad de Investigación Clínica Farmacocinética FP Clinical Pharma en Clínica CIAREC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656508
- Sponsor's protocol ID
- ARVAC-F1-001
- Status last verified
- Oct 2023
- First submitted
- 2 Dec 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared: all of the individual participant data collected during the trial after deidentification and after publication of the results
Publications
Pasquevich KA, Coria LM, Ceballos A, Mazzitelli B, Rodriguez JM, Demaria A, Pueblas Castro C, Bruno L, Saposnik L, Salvatori M, Varese A, Gonzalez S, Gonzalez Martinez VV, Geffner J, Alvarez D; Laboratorio Pablo Cassara R&D and CMC for ARVAC CG consortium; Feleder E, Halabe K, Perez Lera PE, de Oca FM, Vega JC, Lombardo M, Yerino GA, Flo J, Cassataro J. Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in healthy adults. Nat Commun. 2023 Jul 28;14(1):4551. doi: 10.1038/s41467-023-40272-3.
PubMed 37507392
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate Safety, Tolerability and Immunogenicity of a New Recombinant Protein-based Vaccine (ARVAC CG) Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), in a Population of Healthy Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.
- ClinicalTrials.gov ID
- NCT05656508
- Acronym / sponsor ID
- ARVAC-F1-001
- Conditions
- COVID-19 Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Laboratorio Pablo Cassara S.R.L.Industry (pharma, biotech, devices)
- Collaborators
- Universidad Nacional de San Martín (UNSAM), National Council of Scientific and Technical Research, Argentina
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 19 Dec 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.
The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 (ARVAC-CG) in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus.
The main questions it aims to answer are:
- What is the safety and tolerability profile of the two-dose schedule of this new vaccine?
- What is the immune response after each dose of vaccine Participants will receive two doses of the study vaccine 28 days apart. They will be required to complete a total of 7 safety and immunogenicity follow-up visits over a 1-year period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The volunteers will be divided into 2 arms: Group 1 will receive a vaccination schedule of 2 doses of 25 µg of antigen Group 2 will receive a vaccination schedule of 2 doses of 50 µg of antigen
| Arm | Type | Receives |
|---|---|---|
| 25 µg of antigen | Experimental | Biological: ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)Volunteers will receive 2 doses of ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) of 25 µg of antigen, separated by 28 days |
| 50 µg of antigen | Experimental | Biological: ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)Volunteers will receive 2 doses of ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) of 50 µg of antigen, separated by 28 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or female participants between 18 and 55 years of age
- With the ability and willingness to comply with the prohibitions and restrictions specified in the protocol.
- Healthy volunteers, which will be determined by the history referred to interrogation, physical examination, and principal investigator's criteria.
- In fertile female volunteers, negative pregnancy test at the beginning of the study and commitment to use a contraceptive method from the date of signing the consent form until 3 months after vaccine study application. Use of a hormonal contraceptive method must begin at least 28 days prior to study vaccine application. The investigator should assess potential contraceptive method failure (e.g. non-compliance, recent onset) in relation to vaccination. Acceptable effective methods for this study include:
- Participant who agrees to do not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine;
Key exclusion criteria (26 listed)
- History of SARS-CoV-2 infection or known previous disease, within 60 days prior to study entry (at least 60 days from epidemiological discharge).
- Administration of any other commercial vaccine or not, based on:
- Individuals that have not received a complete primary vaccination schedule against SARS-CoV-2 virus (1 or 2 doses, depending on the vaccine used in the primary schedule).
- Administration of complete primary vaccination schedule against SARS-CoV-2 virus (1 or 2 doses, depending on the vaccine received), within 4 months prior to the start of the study.
- Administration of an additional or booster dose after a complete primary vaccination schedule against SARS-CoV-2 virus.
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 |
|---|---|---|
| ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)2 doses of vaccine with an interval between doses of 28 days. Administration route: Intramuscular (IM) injection | Biological | 25 µg of antigen, 50 µg of antigen |
Primary outcome
Safety: Solicited local and systemic reactions after administration of each dose of the vaccine.
Time frame: Day 0 to 7 after each vaccination
Number of volunteers overall and in each dose group with local or systemic vaccine reactogenicity, based on evaluation of solicited adverse events (AEs) recorded on subject memory aids or during clinical assessments
Safety: Unsolicited adverse events after each vaccine dose
Time frame: Day 0 to 30 after each vaccination
Number of volunteers overall and in each dose group with unsolicited vaccine-associated adverse events (AEs) in each dose group
Safety: Serious adverse events
Time frame: Day 0 to 30 after each vaccination
Number of volunteers overall and in each dose group with vaccine-associated serious adverse events (SAEs)
Safety: Variations in the laboratory results
Time frame: Day 0 to 56 after vaccination
Number of volunteers overall and in each dose group with variations in laboratory results from a baseline control at days 7, 28 and 56.
3 secondary outcomes
Immunogenicity: Neutralizing antibodies
Time frame: Day 0 to 28 days after each vaccine dose
Immunogenicity: Total specific antibodies
Time frame: Day 0 to 28 days after each vaccine dose
Immunogenicity: Number of Inteferon (IFN) gamma and interleukin (IL)-4 producing cells directed to Receptor Binding Domain (RBD) (Spike protein region)
Time frame: Day 0 to 28 days after each vaccine dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Derived from this study: PubMed 37507392Pasquevich KA, Coria LM, Ceballos A, Mazzitelli B, Rodriguez JM, Demaria A, Pueblas Castro C, Bruno L, Saposnik L, Salvatori M, Varese A, Gonzalez S, Gonzalez Martinez VV, Geffner J, Alvarez D; Laboratorio Pablo Cassara R&D and CMC for ARVAC CG consortium; Feleder E, Halabe K, Perez Lera PE, de Oca FM, Vega JC, Lombardo M, Yerino GA, Flo J, Cassataro J. Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in healthy adults. Nat Commun. 2023 Jul 28;14(1):4551. doi: 10.1038/s41467-023-40272-3.
- Individual participant dataSharing planned: Yes. Data to be shared: all of the individual participant data collected during the trial after deidentification and after publication of the results
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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.
Gustavo A YERINO, MD. principal investigator
Unidad de Investigación Clínica Farmacocinética FP Clinical Pharma en Clínica CIAREC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2) in people with COVID-19 Vaccine, run by Laboratorio Pablo Cassara S.R.L. at 1 site in Argentina.
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 15 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: finished, as of the sponsor's last update on 22 Dec 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 Argentina. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Solicited local and systemic reactions after administration of each dose of the vaccine. (time frame: Day 0 to 7 after each vaccination). The study lists 4 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 NCT05656508, which also lists 1 linked publication.
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 22 Dec 2023.