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

COMPLETEDPHASE1

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

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.

NCT05656508•Laboratorio Pablo Cassara S.R.L.

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female participants between 18 and 55 years of age
•2. With the ability and willingness to comply with the prohibitions and restrictions specified in the protocol.
•3. Healthy volunteers, which will be determined by the history referred to interrogation, physical examination, and principal investigator's criteria.
•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 do 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 for the SARS-CoV-2 virus.
•8. With laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the study vaccine, which must include:
•1. complete cell blood count (hemoglobin (Hb), leukocyte count and leukocyte formula, platelet count;
+5 more criteria

Exclusion Criteria

•1. History of SARS-CoV-2 infection or known previous disease, within 60 days prior to study entry (at least 60 days from epidemiological discharge).
•2. Administration of any other commercial vaccine or not, 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), within 4 months prior to the start of the study.
•5. Administration of an additional or 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.
•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.
+16 more criteria

Locations (1)

Unidad de Investigación Clínica Farmacocinética FP Clinical Pharma en Clínica CIAREC

Buenos Aires, Argentina

Key Dates

Start Date

April 20, 2022

Primary Completion Date

September 30, 2022

Completion Date

October 29, 2023

Last Updated

December 22, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19 Vaccine

Interventions

ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)

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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.

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

Inclusion Criteria

Exclusion Criteria

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