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

NCT05656508 | Completed Phase 1 DMC

• 1 other identifier: ARVAC-F1-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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)

  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.

  Day 0 to 56 after vaccination

Secondary Outcomes (3)

• Immunogenicity: Neutralizing antibodies

  Day 0 to 28 days after each vaccine dose

• Immunogenicity: Total specific antibodies

  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)

  Day 0 to 28 days after each vaccine dose

Other Outcomes (4)

• Exploratory variables: Neutralizing antibodies titer variation according to primary vaccination schedule

  Day 0 to 28 days after each vaccine dose

• Exploratory variables: Neutralizing antibodies titer variation according to vaccine platform used in the primary scheme

  Day 0 to 28 days after each vaccine dose

• Exploratory variables: Neutralizing antibodies titer variation according to dose of the study vaccine received

  Day 0 to 28 days after each vaccine dose

Study Arms (2)

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

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

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

Interventions

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

25 µg of antigen; 50 µg of antigen

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• Participant who agrees to do 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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorio Pablo Cassara S.R.L.: lead
• Universidad Nacional de San Martín (UNSAM): collaborator
• National Council of Scientific and Technical Research, Argentina: collaborator

Study Sites (1)

Unidad de Investigación Clínica Farmacocinética FP Clinical Pharma en Clínica CIAREC

Buenos Aires, C1431CAF, Argentina

Location

Related Publications (1)

• 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.

  PMID: 37507392 DERIVED

Study Officials

• Gustavo A YERINO, MD.

  Unidad de Investigación Clínica Farmacocinética FP Clinical Pharma en Clínica CIAREC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 19, 2022
• Study Start: April 20, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 29, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available immediately following publication
• Access Criteria: Access will be given to researchers who provide a methodologically sound proposal or whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to the corresponding author of the publication.

Locations

AR (1)