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ARVAC-A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

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.

NCT05752201•Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

View on ClinicalTrials.gov

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. 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 The main questions to be answered are: 1. Phase 2: 1. What si the immune response after one dose of vaccine? 2. What is the safety and tolerability profile of this vaccine? 2. Phase 3 : 1. What is the immune response triggered by each vaccine formulation against Wuhan, gamma, and omicron variants. 2. 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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•\- All subjects who meet the following general criteria will be considered eligible for this trial:
•1. Male or female participants greater than or equal to 18 years of age
•2. With the ability and willingness to comply with the prohibitions and restrictions specified in the protocol.
•3. 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).
•4. 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:
•a) 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.
•5. Participant who agrees to not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine;
•6. Participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of COVID-19 surveillance;
•7. Negative PCR or antigen test for the SARS-CoV-2 virus at enrollment time.
•8. Capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.
+4 more criteria

Exclusion Criteria

•1. History of SARS-CoV-2 infection or known previous disease, within 90 days prior to study entry (at least 90 days from epidemiological discharge).
•2. Administration of any commercial or not commercial vaccine, based on:
•1. Live attenuated virus within 28 days prior to study entry.
•2. Killed virus within 14 days prior to study entry.
•3. 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).
•4. 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.
•5. Administration of more than one booster dose after a complete primary vaccination schedule against SARS-CoV-2 virus.
•6. Individuals that have scheduled to receive any other commercial vaccine in the following 3 months after receiving the study vaccine dose.
•7. Individuals that have participated in a research study within 60 days prior to the start of the study.
•8. History of known allergies or a history of anaphylaxis or any other serious adverse reaction with other vaccines or their excipients.
+17 more criteria

Locations (11)

Fundación Huesped

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Clínicas Belgrano (CICB)

Buenos Aires, Buenos Aires F.D., Argentina

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

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

Clinica Privada del Sol

Córdoba, Córdoba Province, Argentina

FP Clinical Pharma

Buenos Aires, Argentina

Vacunar S.A.

Buenos Aires, Argentina

Instituto Medico Platense

Buenos Aires, Argentina

Instituto de Investigaciones Clínicas de Mar del Plata

Buenos Aires, Argentina

Centro Clínica del Niño y la Familia

Buenos Aires, Argentina

Centro Médico Dra. Laura Maffei - Investigación Clínica Aplicada

Ciudad de Buenos Aires, Argentina

Key Dates

Start Date

February 6, 2023

Primary Completion Date

August 22, 2023

Completion Date

December 7, 2023

Last Updated

December 22, 2023

Enrollment

2,014

ACTUAL participants

Conditions

COVID-19 Vaccine

Interventions

Gamma Variant RBD-based ARVAC-CG vaccine

BIOLOGICAL

Omicron Variant RBD-based ARVAC-CG vaccine

BIOLOGICAL

Bivalent RBD-based ARVAC-CG vaccine

BIOLOGICAL

Placebo (Alum)

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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