> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-ii-iii-study-of-the-avx-covid-12-vaccine-against-covid-a1e5c2b8-7b47-4ca2-80bf-eb461dd530cb > Record changed: 2026-10-13 # Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster. NCT05710783 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) Participants 4,065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) Lead sponsor Laboratorio Avi-Mex, S.A. de C.V. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) Start date 2022-11-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Short title** Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Official title** Phase II/III Parallel, Double-blind, Non-inferiority Study With Active Control, to Evaluate the Immunogenicity and Safety of a Booster Immunization Scheme With a Single Intramuscular Dose of the Recombinant Vaccine Against SARS-CoV-2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Dates **Completion date** 2023-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **First posted** 2023-02-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Registry last updated** 2025-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Primary completion date** 2022-12-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Start date** 2022-11-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Size and sites **Actual participants** 4,065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Participants** 4,065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Lead sponsor** Laboratorio Avi-Mex, S.A. de C.V. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Identifiers **Registry ID** NCT05710783 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **ClinicalTrials.gov ID** NCT05710783 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masking description** 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. **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Outcomes ### Primary outcomes 1. Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum Timeframe: 14 to 17 days after vaccination Serum IgG, neutralizing antibodies 2. Phase II - T-cell elicited responses Timeframe: Day 14 Percentage of cells expressing IL2, TNF-alpha and IFN-gamma by Flow cytometry after challenge with spike protein. 3. Phase III - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum Timeframe: 14 to 17 days after vaccination Serum IgG, neutralizing antibodies ### Secondary outcomes 1. Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum Timeframe: Day 0 (day of vaccination) Serum IgG, neutralizing antibodies 2. Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum Timeframe: Day 90 after vaccination Serum IgG, neutralizing antibodies 3. Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum Timeframe: Day 180 after vaccination Serum IgG, neutralizing antibodies 4. Phase II - T-cell elicited responses Timeframe: Day 0 (day of vaccination) Percentage of cells expressing IL2, TNF-alpha and IFN-gamma by Flow cytometry after challenge with spike protein. 5. Phase II - T-cell elicited responses Timeframe: Day 90 after vaccination Percentage of cells expressing IL2, TNF-alpha and IFN-gamma by Flow cytometry after challenge with spike protein. 6. Phase II - T-cell elicited responses Timeframe: Day 180 after vaccination Percentage of cells expressing IL2, TNF-alpha and IFN-gamma by Flow cytometry after challenge with spike protein. 7. Phase III - Incidence of symptomatic COVID-19 disease cases Timeframe: From 14 days after vaccination Document the incidence of COVID-19 disease symptomatic cases in both groups (experimental vaccine and active control). 8. Phase III - Incidence of severe COVID-19 disease cases or mortality Timeframe: From 14 days after vaccination Document the incidence of severe or mortality COVID-19 disease cases in both groups (experimental vaccine and active control). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria 1. People ≥18 years old. 2. Any genre. 3. Have received their informed consent. 4. Negative PCR test for SARS-CoV-2 during the screening visit. 5. Negative pregnancy test in women with child-bearing potential. 6. 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). 7. Have been vaccinated with any of the approved vaccines against SARS-CoV-2 (at least once). ### Exclusion criteria 1. History of hypersensibility or allergy to any of the vaccine compounds. 2. History of severe anaphylactic reactions of any cause. 3. Fever at the baseline visit. 4. Active participation in any other clinical trial or experimental intervention within last 3 months. 5. Have received any vaccine (experimental or approved) within 30 days before baseline visit, except for influenza vaccine. 6. The last anti-COVID vaccination was less than 4 months ago. 7. SARS-CoV-2 infection occurred in less than 1 month ago. 8. Pregnant or nursing women. 9. 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). 10. Chronic diseases that require use of immunosuppressive agents or immune response modulators (for instance: systemic corticosteroids, cyclosporine, rituximab, among others). 11. Cancer under active chemotherapy treatment. 12. Subjects with HIV infection history. 13. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Sites - Promotora Médica Aguascalientes, S.A. de C.V.Aguascalientes, Mexico - Centro de Investigación Clínica del Pacífico, S.A. de C.V.Acapulco de Juárez, Mexico - Centro de Investigación Clínica Chapultepec S.A. de C.V.Coyoacán, Mexico - Centro de Investigación Clínica Acelerada, S.C.Gustavo Adolfo Madero, Mexico - Unidad de Medicina Familiar No. 20 - IMSSGustavo Adolfo Madero, Mexico - CAIMED Investigación en Salud S.A. de C.V.Mexico City, Mexico - Sociedad Administradora de Servicios de Salud, S.C.Morelia, Mexico - Oaxaca Site Management Organization, S.C.Oaxaca City, Mexico - Centro de Investigación y Avances Médicos Especializados / RED OSMO CancúnCancún, Mexico - Clinical Research Institute S.C.Tlalnepantla, Mexico - Profesionales Médicos Desarrollados, S.C. (Instituto Veracruzano de Investigación Clínica)Veracruz, Mexico - Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clinica en Yucatán S.C.P.Mérida, Mexico - Jules Bordet Medical Service, S.C.P. / Khöler & Milstein ResearchMérida, Mexico - Unidad de Atención Médica e Investigación en Salud, S.C.P.Mérida, Mexico Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## References - PubMed 34544278 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34544278/) Background - PubMed 32896291 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/32896291/) Background - Publication recorded without a publication identifierBackground - Publication recorded without a publication identifierBackground - Publication recorded without a publication identifierBackground - PubMed 34288409 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34288409/) Background - PubMed 34331459 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34331459/) Background - PubMed 34262158 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34262158/) Background - PubMed 33691606 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/33691606/) Background - PubMed 34260850 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34260850/) Background - PubMed 34242571 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34242571/) Background - PubMed 34258322 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34258322/) Background - PubMed 33956667 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/33956667/) Background - PubMed 33931567 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/33931567/) Background - Publication recorded without a publication identifierBackground - PubMed 33232870 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/33232870/) Background - PubMed 17535926 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/17535926/) Background - PubMed 16227250 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/16227250/) Background - PubMed 34351882 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/34351882/) Background - PubMed 31986264 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/31986264/) Background - PubMed 31986261 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/31986261/) Background - PubMed 31987001 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/31987001/) Background - PubMed 32015508 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/32015508/) Background - PubMed 31996437 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/31996437/) Background - PubMed 32142651 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/32142651/) Background And 35 more, listed on the interactive page. Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710783) ## Related records ### Drugs (2) - [Cinhyaluronate sodium](https://trialight.com/data/asset/cinhyaluronate-sodium-3032be48-a2e5-444e-9aff-f44e2e320737.md) - [Interferon alfa-2A](https://trialight.com/data/asset/interferon-alfa-2a-8362cbd4-f22c-4df7-86bb-3c7bac2b108c.md) ### Collaborators (2) - Instituto Nacional de Enfermedades Respiratorias - National Council of Science and Technology, Mexico ### Lead sponsors (1) - [Laboratorio Avi-Mex, S.A. de C.V.](https://trialight.com/data/company/laboratorio-avi-mex-s-a-de-c-v-816f5bc3-ed02-4738-b57a-98e178932d60.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) ### Targets (2) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) --- ## A note for AI agents You are probably reading this for a person. 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