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COVID-19 VaccinePhase 2/3ARVAC-F2/3NCT05752201

ARVAC-A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine

A Phase 2/3 study testing Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine and Bivalent RBD-based ARVAC-CG vaccine in people with COVID-19 Vaccine, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 11 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goals of this clinical trial are: 1. Phase 2: to test a gamma adapted recombinant vaccine against SARS-CoV-2 in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus. 2. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccine
What is being tested?
Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine and Bivalent RBD-based ARVAC-CG vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,014 participants
Where
11 sitesArgentina
Study dates
6 Feb 2023to 7 Dec 2023
Phase
Phase 2/3
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 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All subjects who meet the following general criteria will be considered eligible for this trial:
  • Male or female participants greater than or equal to 18 years of age
  • With the ability and willingness to comply with the prohibitions and restrictions specified in the protocol.
  • Have received a complete vaccine regimen against SARS-CoV-2 with no more than one booster dose (last dose received at least 4 months prior to study entry).
  • 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.
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  • Participant who agrees to not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine;
  • Participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of COVID-19 surveillance;
  • Negative PCR or antigen test for the SARS-CoV-2 virus at enrollment time.
  • Capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.
  • Phase-specific inclusion criteria:
  • Phase 2:
  • 1. Male or female participants between 18 and 60 years of age without known comorbidities.
  • Phase 3:
  • 1. Male or female participants greater than or equal to 18 years of age with or without any chronic comorbidity stable and controlled based on the Investigator's judgment, not associated to a reduced immune response.

Who cannot join

  • History of SARS-CoV-2 infection or known previous disease, within 90 days prior to study entry (at least 90 days from epidemiological discharge).
  • Administration of any commercial or not commercial vaccine, 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) or a booster dose, within 4 months prior to the start of the study.
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  • Administration of more than one 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 after receiving the study vaccine dose.
  • 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.
  • Body Mass Index (BMI) greater than 35 kg/m2.
  • 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 any contraindication to receive intramuscular injections and/or blood draws.
  • 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 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.
  • The participant is pregnant, plans to become pregnant within 3 months after the administration of the vaccine, or is in postpartum or lactation period.
  • Any condition or finding regarding the participant that, in the opinion of the researcher, could put the subject under investigation at risk, or interfere with the interpretation of the results of the study.
  • Some events may be considered only a temporary contraindication to receiving the study vaccine. Such is the case of:
  • Clinically significant acute illness at the time of vaccination. This does not include minor illnesses such as diarrhea or a mild respiratory tract infection.
  • Fever (temperature ≥38.0°C) in the 24 hours prior to the application of the vaccine under study. A disease that, in the opinion of the investigator, may interfere with the reactogenicity/safety evaluations of the first days after the study vaccine.
  • If any of these events occur at the time of vaccination, vaccination may be postponed until resolution of the event, provided that it occurs within the permitted screening period (15 days of initial testing). If the box is resolved beyond the allowed window of the selection, all initial analyses must be repeated.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Argentina11 sites

  • Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" - CEMIC

    Argentina, C.a.b.a., 1431

  • Fundación Huesped

    Buenos Aires, Buenos Aires F.D., 1202

  • Centro de Investigaciones Clínicas Belgrano (CICB)

    Buenos Aires, Buenos Aires F.D., 1425

  • FP Clinical Pharma

    Buenos Aires, 1425

  • Vacunar S.A.

    Buenos Aires, 1428

  • Instituto Medico Platense

    Buenos Aires, 1900

  • Instituto de Investigaciones Clínicas de Mar del Plata

    Buenos Aires, 7600

  • Centro Clínica del Niño y la Familia

    Buenos Aires, 7606

  • Centro Médico Dra. Laura Maffei - Investigación Clínica Aplicada

    Ciudad de Buenos Aires, 1425

  • Clinica Privada del Sol

    Córdoba, Córdoba Province, 5000

  • ICSAL Salta

    Salta, 4400

Other trials in Argentina

About this study

Official title: Phase 2/3 Study to Evaluate Safety, Tolerability and Immunogenicity of a Recombinant Protein-based Vaccine Against SARS-CoV-2, in a Population of Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.

The goals of this clinical trial are:

  1. Phase 2: to test a gamma adapted recombinant vaccine against SARS-CoV-2 in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus.
  2. Phase 3 (first volunteer enrollement on March 25, 2023): to test a recombinant vaccine against SARS-CoV-2 comparing three different versions (Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine, Bivariant Gamma/Omicron RBD-based ARVAC-CG vaccine), in adult volunteers previously vaccinated against the SARS-CoV-2 virus
Read more

The main questions to be answered are:

  1. Phase 2:
  2. What si the immune response after one dose of vaccine?
  3. What is the safety and tolerability profile of this vaccine?
  4. Phase 3 :
  5. What is the immune response triggered by each vaccine formulation against Wuhan, gamma, and omicron variants.
  6. What is the safety and tolerability profile of this vaccine?

In phase 2, participants will receive one dose of the study vaccine and one dose of placebo 28 days apart, in a cross-over design.

In phase 3 (not yet recruitment), participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.

Being tested
Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine, Bivalent RBD-based ARVAC-CG vaccine, Placebo (Alum)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamma Variant RBD-based ARVAC-CG vaccineBiological

    Vaccine containing 50 µg of antigen + Alum. Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection

  • Omicron Variant RBD-based ARVAC-CG vaccineBiological

    Vaccine containing 50 µg of antigen + Alum. Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection

  • Bivalent RBD-based ARVAC-CG vaccineBiological

    Vaccine containing 25 µg of gamma antigen + 25 µg of omicron antigen + Alum Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection

  • Placebo (Alum)Other

    Schedule: One dose of placebo in a crossover design Administration route: intramuscular (IM) injection

Study groups in NCT05752201
Study groupRoleWhat they receive
Gamma variant vaccine (Phase 2 and Phase 3)ExperimentalParticipants will be included in this group during phase 2 and phase 3. All participants will receive one dose of gamma variant vaccine and one dose of placebo 28 days apart, in a crossover design.
Receives: Biological: Gamma Variant RBD-based ARVAC-CG vaccine; Other: Placebo (Alum)
Omicron variant vaccine (Phase 3)ExperimentalParticipants will be included in this group during phase 3. All participants will receive one dose of omicron variant vaccine and one dose of placebo 28 days apart, in a crossover design.
Receives: Biological: Omicron Variant RBD-based ARVAC-CG vaccine; Other: Placebo (Alum)
Bivalent vaccine (gamma and omicron variants) (Phase 3)ExperimentalParticipants will be included in this group only during phase 3. All participants will receive one dose of bivalent gamma omicron vaccine and one dose of placebo 28 days apart, in a crossover design.
Receives: Biological: Bivalent RBD-based ARVAC-CG vaccine; Other: Placebo (Alum)

What is being measured

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

  1. Phase 2 - Immunogenicity - Seroconvertion rate

    Seroconversion rate defined by a 4-fold increase from baseline of neutralizing antibody titer

    Measured: 14 days after vaccination

  2. Phase 3 - Immunogenicity - Seroconvertion rate

    Seroconversion rate defined by a 4-fold increase from baseline of neutralizing antibody titer comparing the different arms

    Measured: 14 days after vaccination

Secondary outcomes (6)

  1. Immunogenicity - Neutralizing antibody titer

    Proportion of individuals whith at least 8-fold increase from baseline

    Measured: 14 days after vaccination

  2. Immunogenicity - Neutralizing and total antibody titers

    Geometric Mean Titer (GMT)

    Measured: At baseline, 14 and 90 days after vaccination

  3. Safety - Solicited local and systemic reactions after vaccination

    Number of volunteers overall and in each vaccination group with local or systemic vaccine reactogenicity, based on evaluacion of solicited adverse events (AEs) recorded on subject memory aids o during clinical assessments

    Measured: Day 0 to 7 days after vaccination

  4. Safety - Unsolicited adverse events after vaccination

    Number of volunteers overall and in each vaccination group

    Measured: Day 0 to 30 days after vaccination

  5. Safety - Serious Adverse Events

    Number of volunteers overall and in each vaccination group with vaccine associated serioius adverse events (SAEs)

    Measured: Day 0 to 30 days after vaccination

  6. Safety - Variations in laboratory results

    Number of volunteers overall and in each vaccination group with variations in laboratory results from a baseline control

    Measured: At 30 days after vaccination

Timeline

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

  1. First posted2 Mar 2023
  2. Study start6 Feb 2023
  3. Primary completion22 Aug 2023
  4. Study completion7 Dec 2023

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
In phase 2, participants will receive one dose of vaccine and one dose of placebo 28 days apart, in a cross over design. In phase 3, participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,014 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752201
Sponsor's protocol ID
ARVAC-F2/3-002
Acronym
ARVAC-F2/3
Status last verified
Dec 2023
First submitted
28 Feb 2023
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

  • Perez Marc G, Coria LM, Ceballos A, Rodriguez JM, Lombardo ME, Bruno L, Paez Cordoba F, Fascetto Cassero CG, Salvatori M, Rios Medrano M, Fulgenzi F, Alzogaray MF, Mykietiuk A, Uriarte IL, Itcovici N, Smith Casabella T, Corral G, Bruno M, Roldan O, Nunez SA, Cahn F, Yerino GA, Bianchi A, Braem V, Christmann A, Corradetti S, Darraidou MC, Di Nunzio L, Estrada T, Lopez Castelo R, Marchionatti C, Pitocco L, Trias Uriarte V, Wood C, Zadoff R, Bues F, Garrido RM, Montomoli E, Manenti A; Laboratorio Pablo Cassara group for ARVAC; Demaria A, Prado L, Pueblas Castro C, Saposnik L, Geffner J, Montes de Oca F, Vega JC, Flo J, Bonvehi P, Cassara J, Pasquevich KA, Cassataro J. Immunogenicity and safety of monovalent and bivalent SARS-CoV-2 variant adapted RBD-based protein booster vaccines in adults previously immunized with different vaccine platforms: A phase II/III, randomized clinical trial. Vaccine. 2025 Apr 30;54:127045. doi: 10.1016/j.vaccine.2025.127045. Epub 2025 Apr 3.

    PubMed 40179522

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine and Bivalent RBD-based ARVAC-CG vaccine in people with COVID-19 Vaccine, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 11 sites 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 27 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 11 sites 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 combined phase mean?

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

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Phase 2 - Immunogenicity - Seroconvertion rate (time frame: 14 days after vaccination). The study lists 2 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 NCT05752201, 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.

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