Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster.

NCT05710783 | Completed Phase 2 DMC

• 1 other identifier: AVX-SARS-CoV-2-VAC-005
• Study Type: interventional
• Target: 4,065
• Locations: 1 country
• Sites: 14

Brief Summary

This is a phase II/III parallel, double-blind, active-controlled, non-inferiority study to evaluate immunogenicity and safety of a booster immunization scheme of a single intramuscular dose of the recombinant vaccine against SARS-CoV-2 (AVX/COVID-12 vaccine) based on live recombinant Newcastle disease virus (rNDV) vector in healthy adults with a history of vaccination against COVID-19. The study is divided into two phases with immuno-bridging and 3000 healthy subjects showing evidence of prior immunity to SARS-CoV-2 are estimated to enrol. To verify non-inferiority in a determined number of subjects an intramuscular dose of the COVID-19 vaccine (ChAdOx-1-S\[recombinant\]) shall be used as active control in originally randomised subjects. The study shall be carried out in several sites of clinical research in Mexico.

Conditions

SARS-CoV-2 Infection

Keywords

Newcastle Disease Virus; rNDV; COVID-19; SARS-Cov-2 Vaccine; Booster COVID-19 Vaccine

Outcome Measures

Primary Outcomes (3)

• Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum

  Serum IgG, neutralizing antibodies

  14 to 17 days after vaccination

• Phase II - T-cell elicited responses

  Percentage of cells expressing IL2, TNF-alpha and IFN-gamma by Flow cytometry after challenge with spike protein.

  Day 14

• Phase III - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum

  Serum IgG, neutralizing antibodies

  14 to 17 days after vaccination

Secondary Outcomes (8)

• Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum

  Day 0 (day of vaccination)

• Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum

  Day 90 after vaccination

• Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum

  Day 180 after vaccination

• Phase II - T-cell elicited responses

  Day 0 (day of vaccination)

• Phase II - T-cell elicited responses

  Day 90 after vaccination

Other Outcomes (7)

• Phase II/Phase III - Safety: Adverse Events

  After Day 14 after vaccination

• Phase II -Basal titers of Anti-N and anti-S antibodies, distribution of anti-N and anti-S antibodies within study population

  Day 0 (day of vaccination)

• Phase II - Increase in titers of Anti-N and anti-S antibodies, distribution of anti-N and anti-S antibodies within study population

  Day 14 after vaccination

Study Arms (7)

Phase II - Experimental

EXPERIMENTAL

AVX-COVID/12 Dose: 10\^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response, Cellular response

Biological: AVX-COVID/12

Phase II - Active Control

ACTIVE COMPARATOR

ChAdOx-1-S\[recombinant\]) intramuscular Study parameters: Safety, Serological response, Cellular response

Biological: ChAdOx-1-S[recombinant]

Phase III - Experimental

EXPERIMENTAL

AVX-COVID/12 Intramuscular Dose: 10\^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response

Biological: AVX-COVID/12

Phase III - Active Control

ACTIVE COMPARATOR

ChAdOx-1-S\[recombinant\]) intramuscular Study parameters: Safety, Serological response

Biological: ChAdOx-1-S[recombinant]

Phase III - Security

EXPERIMENTAL

AVX-COVID/12 Intramuscular Dose: 10\^8.0 EID50/ intramuscular dose Study parameters: Safety.

Biological: AVX-COVID/12

Phase II- Experimental

EXPERIMENTAL

AVX-COVID/12 Dose: 10\^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response.

Biological: AVX-COVID/12

Phase II- Active Control

ACTIVE COMPARATOR

ChAdOx-1-S\[recombinant\]) intramuscular Study parameters: Safety, Serological response.

Interventions

AVX-COVID/12 BIOLOGICAL

Single dose IM administration of a Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Also known as: Recombinant NDV Vectored Vaccine for SARS-CoV-2

Phase II - Experimental; Phase II- Experimental; Phase III - Experimental; Phase III - Security

ChAdOx-1-S[recombinant] BIOLOGICAL

Single dose IM administration of ChAdOx1 nCOV-19 (Astra-Zeneca) adenovirus-vectored vaccine

Also known as: AstraZeneca COVID vaccine

Phase II - Active Control; Phase III - Active Control

Eligibility Criteria

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

You may qualify if:

• People ≥18 years old.
• Any genre.
• Have received their informed consent.
• Negative PCR test for SARS-CoV-2 during the screening visit.
• Negative pregnancy test in women with child-bearing potential.
• Commitment to maintain adequate prevention measures to avoid contagion by SARS-CoV-2 throughout their participation in the study considering their strict following for the first 14 days after the baseline visit (use of face masks in closed places, social distancing measures in open spaces and frequent handwashing).
• Have been vaccinated with any of the approved vaccines against SARS-CoV-2 (at least once).

You may not qualify if:

• History of hypersensibility or allergy to any of the vaccine compounds.
• History of severe anaphylactic reactions of any cause.
• Fever at the baseline visit.
• Active participation in any other clinical trial or experimental intervention within last 3 months.
• Have received any vaccine (experimental or approved) within 30 days before baseline visit, except for influenza vaccine.
• The last anti-COVID vaccination was less than 4 months ago.
• SARS-CoV-2 infection occurred in less than 1 month ago.
• Pregnant or nursing women.
• Child-bearing potential and sexually active women who do not use highly effective birth control methods (oral contraceptives, intrauterine device, subcutaneous implant, transdermal patch used at least within 3 months) at the time of enrolment. Fertile and sexually active men not willing to strictly use (in all relationships) barrier methods of birth control throughout study. Those participants (both sexes) not sexually active can participate in the study if they are committed to avoid sexual intercourse throughout study (6 months).
• Chronic diseases that require use of immunosuppressive agents or immune response modulators (for instance: systemic corticosteroids, cyclosporine, rituximab, among others).
• Cancer under active chemotherapy treatment.
• Subjects with HIV infection history.
• Subjects with chronic renal or liver disease who have shown an infectious condition that required hospitalization or treatment with intravenous drugs within the last year prior baseline visit.

Sponsors & Collaborators

• Laboratorio Avi-Mex, S.A. de C.V.: lead
• National Council of Science and Technology, Mexico: collaborator
• Instituto Nacional de Enfermedades Respiratorias: collaborator

Study Sites (14)

Promotora Médica Aguascalientes, S.A. de C.V.

Aguascalientes, Aguascalientes, 20230, Mexico

Location

Centro de Investigación Clínica del Pacífico, S.A. de C.V.

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

Centro de Investigación Clínica Chapultepec S.A. de C.V.

Coyoacán, Mexico City, 04100, Mexico

Location

Centro de Investigación Clínica Acelerada, S.C.

Gustavo Adolfo Madero, Mexico City, 07369, Mexico

Location

Unidad de Medicina Familiar No. 20 - IMSS

Gustavo Adolfo Madero, Mexico City, 07760, Mexico

Location

CAIMED Investigación en Salud S.A. de C.V.

Mexico City, Mexico City, 06760, Mexico

Location

Sociedad Administradora de Servicios de Salud, S.C.

Morelia, Michoacán, 58260, Mexico

Location

Oaxaca Site Management Organization, S.C.

Oaxaca City, Oaxaca, 68000, Mexico

Location

Centro de Investigación y Avances Médicos Especializados / RED OSMO Cancún

Cancún, Quintana Roo, 77506, Mexico

Location

Clinical Research Institute S.C.

Tlalnepantla, State of Mexico, 54055, Mexico

Location

Profesionales Médicos Desarrollados, S.C. (Instituto Veracruzano de Investigación Clínica)

Veracruz, Veracruz, 91855, Mexico

Location

Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clinica en Yucatán S.C.P.

Mérida, Yucatán, 97070, Mexico

Location

Jules Bordet Medical Service, S.C.P. / Khöler & Milstein Research

Mérida, Yucatán, 97070, Mexico

Location

Unidad de Atención Médica e Investigación en Salud, S.C.P.

Mérida, Yucatán, 97070, Mexico

Location

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MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Gustavo Peralta

  Laboratorio Avi-Mex, S.A. de C.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization of patients shall be carried out by a computerized system. Once the informed consent signed, the patient shall be allocated with a number coding with all his/her pseudonymously information during collection and completely anonymised during analysis. The randomization of the first 400 study subjects will include, in addition to 1:1 randomization (experimental vaccine: active control), randomization to participate as a subsample subject for cellular immune response determinations. Once the 1664 subjects have been randomised, the following study subjects shall be designated as experimental vaccine receptors until have enrolled all the study subjects.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Immuno-bridging

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 2, 2023
• Study Start: November 9, 2022
• Primary Completion: December 28, 2022
• Study Completion: September 10, 2023
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available immediately following publication and for 12 months thereafter.
• Access Criteria: Data will be available only to investigators whose proposed use of the data has been authorized by an independent review committee and the ethics committees involved in the authorization of the protocol, and/or the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) in Mexico if required by law. The permitted use of the data will be as authorized. Proposals or requests should be directed to gustavo.peralta@avimex.com.mx and authorized data requestors must sign a data access agreement.

Locations

ME (14)