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

NCT05752201 | Completed Phase 2 DMC

• 1 other identifier: ARVAC-F2/3-002
• Study Type: interventional
• Target: 2,014
• Locations: 1 country
• Sites: 11

Brief Summary

The goals of this clinical trial are:

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

Conditions

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (2)

• Phase 2 - Immunogenicity - Seroconvertion rate

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

  14 days after vaccination

• Phase 3 - Immunogenicity - Seroconvertion rate

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

  14 days after vaccination

Secondary Outcomes (6)

• Immunogenicity - Neutralizing antibody titer

  14 days after vaccination

• Immunogenicity - Neutralizing and total antibody titers

  At baseline, 14 and 90 days after vaccination

• Safety - Solicited local and systemic reactions after vaccination

  Day 0 to 7 days after vaccination

• Safety - Unsolicited adverse events after vaccination

  Day 0 to 30 days after vaccination

• Safety - Serious Adverse Events

  Day 0 to 30 days after vaccination

Other Outcomes (2)

• Exploratory - Antibody Titers in saliva

  At baseline and day 14 after vaccination

• Exploratory - Immunogenicity

  At baseline and 14 days after vaccination

Study Arms (3)

Gamma variant vaccine (Phase 2 and Phase 3)

EXPERIMENTAL

Participants 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.

Biological: Gamma Variant RBD-based ARVAC-CG vaccine; Other: Placebo (Alum)

Omicron variant vaccine (Phase 3)

EXPERIMENTAL

Participants 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.

Biological: Omicron Variant RBD-based ARVAC-CG vaccine; Other: Placebo (Alum)

Bivalent vaccine (gamma and omicron variants) (Phase 3)

EXPERIMENTAL

Participants 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.

Biological: Bivalent RBD-based ARVAC-CG vaccine; Other: Placebo (Alum)

Interventions

Gamma Variant RBD-based ARVAC-CG vaccine BIOLOGICAL

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

Gamma variant vaccine (Phase 2 and Phase 3)

Omicron Variant RBD-based ARVAC-CG vaccine BIOLOGICAL

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

Omicron variant vaccine (Phase 3)

Bivalent RBD-based ARVAC-CG vaccine BIOLOGICAL

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

Bivalent vaccine (gamma and omicron variants) (Phase 3)

Placebo (Alum) OTHER

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

Bivalent vaccine (gamma and omicron variants) (Phase 3); Gamma variant vaccine (Phase 2 and Phase 3); Omicron variant vaccine (Phase 3)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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:
• 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 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 2:
• \. Male or female participants between 18 and 60 years of age without known comorbidities.
• Phase 3:
• \. 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.

You may not qualify if:

• 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.
• 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.).

Sponsors & Collaborators

• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno: lead
• Universidad Nacional de San Martín (UNSAM): collaborator
• National Council of Scientific and Technical Research, Argentina: collaborator
• Laboratorio Pablo Cassará S.R.L.: collaborator

Study Sites (11)

Fundación Huesped

Buenos Aires, Buenos Aires F.D., 1202, Argentina

Location

Centro de Investigaciones Clínicas Belgrano (CICB)

Buenos Aires, Buenos Aires F.D., 1425, Argentina

Location

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

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

Location

Clinica Privada del Sol

Córdoba, Córdoba Province, 5000, Argentina

Location

FP Clinical Pharma

Buenos Aires, 1425, Argentina

Location

Vacunar S.A.

Buenos Aires, 1428, Argentina

Location

Instituto Medico Platense

Buenos Aires, 1900, Argentina

Location

Instituto de Investigaciones Clínicas de Mar del Plata

Buenos Aires, 7600, Argentina

Location

Centro Clínica del Niño y la Familia

Buenos Aires, 7606, Argentina

Location

Centro Médico Dra. Laura Maffei - Investigación Clínica Aplicada

Ciudad de Buenos Aires, 1425, Argentina

Location

ICSAL Salta

Salta, 4400, Argentina

Location

Related Publications (1)

• 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.

  PMID: 40179522 DERIVED

MeSH Terms

Interventions

aluminum sulfate

Study Officials

• Pablo Bonvehí, MD

  Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

  PRINCIPAL INVESTIGATOR

• Gustavo Yerino, MD

  FP Clinical Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Infectious Diseases Section

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 2, 2023
• Study Start: February 6, 2023
• Primary Completion: August 22, 2023
• Study Completion: December 7, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data 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 (11)