SARS-CoV-2 InfectionPhase 2/3NCT05710783
Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster.
A Phase 2/3 study testing AVX-COVID/12 and ChAdOx-1-S[recombinant] in people with SARS-CoV-2 Infection, run by Laboratorio Avi-Mex, S.A. de C.V. at 14 sites in Mexico.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- AVX-COVID/12 and ChAdOx-1-S[recombinant]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,065 participants
- Where
- 14 sitesMexico
- Study dates
- 9 Nov 2022to 10 Sep 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Mexico14 sites
Centro de Investigación Clínica del Pacífico, S.A. de C.V.
Acapulco de Juárez, Guerrero, 39670
Promotora Médica Aguascalientes, S.A. de C.V.
Aguascalientes, Aguascalientes, 20230
Centro de Investigación y Avances Médicos Especializados / RED OSMO Cancún
Cancún, Quintana Roo, 77506
Centro de Investigación Clínica Chapultepec S.A. de C.V.
Coyoacán, Mexico City, 04100
Centro de Investigación Clínica Acelerada, S.C.
Gustavo Adolfo Madero, Mexico City, 07369
Unidad de Medicina Familiar No. 20 - IMSS
Gustavo Adolfo Madero, Mexico City, 07760
Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clinica en Yucatán S.C.P.
Mérida, Yucatán, 97070
Jules Bordet Medical Service, S.C.P. / Khöler & Milstein Research
Mérida, Yucatán, 97070
Unidad de Atención Médica e Investigación en Salud, S.C.P.
Mérida, Yucatán, 97070
CAIMED Investigación en Salud S.A. de C.V.
Mexico City, Mexico City, 06760
Sociedad Administradora de Servicios de Salud, S.C.
Morelia, Michoacán, 58260
Oaxaca Site Management Organization, S.C.
Oaxaca City, Oaxaca, 68000
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, 54055
Profesionales Médicos Desarrollados, S.C. (Instituto Veracruzano de Investigación Clínica)
Veracruz, Veracruz, 91855
About this study
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
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.
Read the detailed description
General objective:
To demonstrate immunogenicity and safety of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in previously vaccinated subjects and prove non-inferiority producing neutralizing antibodies anti-COVID-19 from 14 days after administration in comparison to the active control, whose efficacy has been formerly established in a placebo-controlled clinical study.
Primary objective:
Phase II:
To demonstrate immunogenicity of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot to increase levels of Spike protein to ACE2 binding-inhibitory antibodies, as well as to increase titres of neutralizing antibodies anti-COVID-19 from 14 days after vaccine administration.
Phase III:
To demonstrate non-inferiority of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot for seroconversion and production of neutralizing antibodies anti-COVID-19 from 14 days after vaccine administration compared to active control, whose efficacy has been formerly established in a placebo-controlled clinical study.
Secondary objectives:
Phase II:
To evaluate the extent of the increase in the neutralizing titres after 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot.
To evaluate production of interferon-gamma by peripheral blood T lymphocytes in response to the Spike protein or its derivatives peptides stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the study population.
To compare production of interferon-gamma by peripheral blood T lymphocytes in response to the Spike protein or its derivatives peptides stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the study population to production in subjects vaccinated with active control.
Phase III:
To document the incidence of symptomatic COVID-19 disease cases in both groups (experimental vaccine and active control) from 14 days after administration.
To document the incidence of severe or mortality COVID-19 disease cases in both groups (experimental vaccine and active control) from 14 days after administration.
Safety objective (primary):
Both Phases:
To evaluate safety of AVX/COVID-12 vaccine immunization as a single intramuscular booster shot in comparison to the active control.
Exploratory objectives:
Phase II:
To evaluate the extent of the increase in following neutralizing titres 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot as per the history of immunization/infection at the time of enrolment.
To evaluate the neutralizing capacity of anti-SARS-CoV-2 antibodies gained following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in neutralization tests of pseudovirus expressing Spike proteins derived from SARS-CoV-2 variants of concern.
To evaluate production of cytokines by peripheral blood T lymphocytes in response to the Spike protein or its derivatives (peptides) stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the population study.
To compare production of cytokines by peripheral blood T lymphocytes in response to the Spike protein or its derivatives (peptides) stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the population study to production in subjects vaccinated with active control.
Phase III:
To compare geometric means of neutralizing titres after AVX/COVID-12 (108.0 EID50/dose) vaccination as a single intramuscular booster shot in the following active-controlled subgroups:
- Subjects younger than 65 years.
- Subjects older than 65 years.
- Subjects with at least one comorbidity (any).
- Subjects with obesity (BMI >30).
- Subjects with Diabetes Mellitus.
- Subjects with hypertension.
- Subjects with smoking history.
- Subjects with asthma.
- Subjects with cardiovascular disease.
- Subjects with chronic obstructive pulmonary disease.
- Subjects with chronic renal disease.
- Subjects with liver disease.
- Subjects with cancer history.
Clinical trial hypothesis:
Phase II:
In subjects with prior anti-SARS-CoV-2 vaccination longer than 4 months ago, 14 days after intramuscular administration of the AVX/COVID-12 vaccine, ≥80% of the subjects showed an inhibitory capacity of the receptor-binding domain (spike protein binds to ACE2) above 95% and levels of neutralizing titres statistically greater than baseline tires (vaccination day).
Phase III:
Immunogenicity assessed as seroconversion rate and production of neutralizing antibodies after administration of the AVX/COVID-12 vaccine as a single intramuscular booster shot of 108.0 EID50/dose showed non-inferiority to active control from 14 days after administration.
Justification of the product use in clinical research.
Nonclinical studies and Phase I clinical study have shown safety of the AVX/COVID-12 vaccine by intramuscular route. Signs of immunogenicity in several animals are clear. Evaluation of the immune response in healthy volunteers in the Phase I clinical study after administration of the vaccine by intramuscular route as a single dose of 108.0 EID50/dose showed immunogenicity of the vaccine. Partial reports from a Phase II boosting study in subjects with low levels of immunity at the time of enrolment strongly suggest the vaccine is safe and immunogenic in this population. Altogether, these data justify the continuation of the AVX/COVID-12 vaccine development program. Due to the advanced stage of the pandemics and vaccination programs worldwide, it is important to assess the capacity of the AVX/COVID-12 vaccine to boost the pre-existing immunity in open previously vaccinated population.
Study design:
A phase II/III parallel, double-blind, active-controlled, non-inferiority study to evaluate immunogenicity and safety of a booster immunization scheme with 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.
Summarised description of Phase II design:
Subjects who meet the study inclusion and not exclusion criteria shall be randomised (1:1) to receive the AVX/COVID-12 vaccine or active control.
From the first 400 subjects of study samples corresponding to the efficacy criteria for Phases II and III shall be collected (including samples to determine cell response in a randomly-defined subgroup).
If at the end of the main endpoint assessment of the study phase corresponding to Phase II (day 14) it is determined the intervention with AVX-COVID-12 vaccine did not meet the specified objective (i. e., neutralizing capacity above 95% was not showed in 80% of the population vaccinated in surrogate testing and a significant change when comparing the geometric means of population neutralizing antibodies titres from days 0 to 14) the enrolment shall be stopped in order to meet the criteria related to the Phase III objectives, otherwise the enrolment shall continue consecutively.
Additionally, the first 400 subjects enrolled (corresponding to Phase II (200 vaccinated with the experimental vaccine and 200 with the active control)) shall be evaluated 90 and 180 days after vaccination to determine the humoral immune response performance at these moments.
A sub-sample of 100 subjects randomly selected (50 experimental vaccine and 50 active control) shall be evaluated regarding cell-mediated immune response in addition to the humoral response at the time of enrolment and 14, 90 and 180 days after vaccination.
Comparison of the safety evaluation related to Phase II shall be carried out with the population receiving active control as reference.
An interim futility analysis shall be carried out for non-inferiority criteria of Phase III at the end of enrolment corresponding to Phase II by Fleming-alpha spending function.
Summarised description of Phase III design:
In total 3832 subjects shall be enrolled divided into 3000 subjects to receive the experimental vaccine (2168 + 832 (632 Phase III + 200 from Phase II/III)) and 832 subjects (632 Phase II + 200 from Phase II/III) will receive active control.
The first 1664 subjects enrolled shall be randomised 1:1 to receive the experimental vaccine or active control and at the end of this phase the subsequent number of subjects enrolled shall receive only the experimental vaccine up to 3000 subjects.
From the first 1664 subjects of study (832 randomised to receive the experimental vaccine and 832 vaccinated with active control) samples shall be collected on days 0 and 14 to determine total titres of anti-S IgG, total titres of anti-N IgG and anti-SARS-CoV-2 neutralizing titres.
Three thousand subjects from safety population and 832 subjects vaccinated with active control shall be followed-up to 180 days to detect symptomatic cases of COVID-19 proved with genetic material detection from nasal/mouth mucus by PCR.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- AVX-COVID/12, ChAdOx-1-S[recombinant]
- Keywords
- Newcastle Disease Virus, rNDV, COVID-19, SARS-Cov-2 Vaccine, Booster COVID-19 Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX-COVID/12Biological
Also called Recombinant NDV Vectored Vaccine for SARS-CoV-2
Single dose IM administration of a Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2
ChAdOx-1-S[recombinant]Biological
Also called AstraZeneca COVID vaccine
Single dose IM administration of ChAdOx1 nCOV-19 (Astra-Zeneca) adenovirus-vectored vaccine
| Study group | Role | What they receive |
|---|---|---|
| Phase II - Experimental | Experimental | AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response, Cellular response Receives: Biological: AVX-COVID/12 |
| Phase II - Active Control | Active comparator | ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response, Cellular response Receives: 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 Receives: Biological: AVX-COVID/12 |
| Phase III - Active Control | Active comparator | ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response Receives: Biological: ChAdOx-1-S[recombinant] |
| Phase III - Security | Experimental | AVX-COVID/12 Intramuscular Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety. Receives: Biological: AVX-COVID/12 |
| Phase II- Experimental | Experimental | AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response. Receives: Biological: AVX-COVID/12 |
| Phase II- Active Control | Active comparator | ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Serum IgG, neutralizing antibodies
Measured: 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.
Measured: Day 14
Phase III - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Serum IgG, neutralizing antibodies
Measured: 14 to 17 days after vaccination
Secondary outcomes (8)
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Serum IgG, neutralizing antibodies
Measured: Day 0 (day of vaccination)
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Serum IgG, neutralizing antibodies
Measured: Day 90 after vaccination
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Serum IgG, neutralizing antibodies
Measured: Day 180 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.
Measured: Day 0 (day of 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.
Measured: Day 90 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.
Measured: Day 180 after vaccination
Phase III - Incidence of symptomatic COVID-19 disease cases
Document the incidence of COVID-19 disease symptomatic cases in both groups (experimental vaccine and active control).
Measured: From 14 days after vaccination
Phase III - Incidence of severe COVID-19 disease cases or mortality
Document the incidence of severe or mortality COVID-19 disease cases in both groups (experimental vaccine and active control).
Measured: From 14 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start9 Nov 2022
- Primary completion28 Dec 2022
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Immuno-bridging
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Avi-Mex, S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Council of Science and Technology, Mexico, Instituto Nacional de Enfermedades Respiratorias
- Responsible party
- Sponsor
- Investigators
- Gustavo Peralta, Study director, Laboratorio Avi-Mex, S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710783
- Sponsor's protocol ID
- AVX-SARS-CoV-2-VAC-005
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data (including data dictionaries) will not be shared, but only to the extent permitted in the informed consent and under Mexican law.
Publications
Lara-Puente JH, Carreno JM, Sun W, Suarez-Martinez A, Ramirez-Martinez L, Quezada-Monroy F, Paz-De la Rosa G, Vigueras-Moreno R, Singh G, Rojas-Martinez O, Chagoya-Cortes HE, Sarfati-Mizrahi D, Soto-Priante E, Lopez-Macias C, Krammer F, Castro-Peralta F, Palese P, Garcia-Sastre A, Lozano-Dubernard B. Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs. mBio. 2021 Oct 26;12(5):e0190821. doi: 10.1128/mBio.01908-21. Epub 2021 Sep 21.
PubMed 34544278Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.
PubMed 32896291Determining Sample Sizes Needed to Detect a Difference between Two Proportions. In: Statistical Methods for Rates and Proportions. John Wiley & Sons, Ltd, 2003: 64-85.
Ritchie H, Ortiz-Ospina E, Beltekian D, et al. Coronavirus Pandemic (COVID-19). Our World in Data 2020; published online March 5. https://ourworldindata.org/covid-cases (accessed Aug 2, 2021).
Exceso de Mortalidad en México - Coronavirus. https://coronavirus.gob.mx/exceso-de-mortalidad-en-mexico/ (accessed Aug 2, 2021).
Dhillon P, Altmann D, Male V. COVID-19 vaccines: what do we know so far? FEBS J. 2021 Sep;288(17):4996-5009. doi: 10.1111/febs.16094. Epub 2021 Jul 19.
PubMed 34288409Zamai L, Rocchi MBL. Hypothesis: Possible influence of antivector immunity and SARS-CoV-2 variants on efficacy of ChAdOx1 nCoV-19 vaccine. Br J Pharmacol. 2022 Jan;179(2):218-226. doi: 10.1111/bph.15620. Epub 2021 Jul 31.
PubMed 34331459Barros-Martins J, Hammerschmidt SI, Cossmann A, Odak I, Stankov MV, Morillas Ramos G, Dopfer-Jablonka A, Heidemann A, Ritter C, Friedrichsen M, Schultze-Florey C, Ravens I, Willenzon S, Bubke A, Ristenpart J, Janssen A, Ssebyatika G, Bernhardt G, Munch J, Hoffmann M, Pohlmann S, Krey T, Bosnjak B, Forster R, Behrens GMN. Immune responses against SARS-CoV-2 variants after heterologous and homologous ChAdOx1 nCoV-19/BNT162b2 vaccination. Nat Med. 2021 Sep;27(9):1525-1529. doi: 10.1038/s41591-021-01449-9. Epub 2021 Jul 14.
PubMed 34262158He Q, Mao Q, An C, Zhang J, Gao F, Bian L, Li C, Liang Z, Xu M, Wang J. Heterologous prime-boost: breaking the protective immune response bottleneck of COVID-19 vaccine candidates. Emerg Microbes Infect. 2021 Dec;10(1):629-637. doi: 10.1080/22221751.2021.1902245.
PubMed 33691606Normark J, Vikstrom L, Gwon YD, Persson IL, Edin A, Bjorsell T, Dernstedt A, Christ W, Tevell S, Evander M, Klingstrom J, Ahlm C, Forsell M. Heterologous ChAdOx1 nCoV-19 and mRNA-1273 Vaccination. N Engl J Med. 2021 Sep 9;385(11):1049-1051. doi: 10.1056/NEJMc2110716. Epub 2021 Jul 14. No abstract available.
PubMed 34260850Hill JA, Ujjani CS, Greninger AL, Shadman M, Gopal AK. Immunogenicity of a heterologous COVID-19 vaccine after failed vaccination in a lymphoma patient. Cancer Cell. 2021 Aug 9;39(8):1037-1038. doi: 10.1016/j.ccell.2021.06.015. Epub 2021 Jun 26. No abstract available.
PubMed 34242571Velasco M, Galan MI, Casas ML, Perez-Fernandez E, Martinez-Ponce D, Gonzalez-Pineiro B, Castilla V, Guijarro C; Alcorcon COVID-19 Working Group. Impact of Previous Coronavirus Disease 2019 on Immune Response After a Single Dose of BNT162b2 Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine. Open Forum Infect Dis. 2021 Jun 4;8(7):ofab299. doi: 10.1093/ofid/ofab299. eCollection 2021 Jul.
PubMed 34258322Levi R, Azzolini E, Pozzi C, Ubaldi L, Lagioia M, Mantovani A, Rescigno M. One dose of SARS-CoV-2 vaccine exponentially increases antibodies in individuals who have recovered from symptomatic COVID-19. J Clin Invest. 2021 Jun 15;131(12):e149154. doi: 10.1172/JCI149154.
PubMed 33956667Reynolds CJ, Pade C, Gibbons JM, Butler DK, Otter AD, Menacho K, Fontana M, Smit A, Sackville-West JE, Cutino-Moguel T, Maini MK, Chain B, Noursadeghi M; UK COVIDsortium Immune Correlates Network; Brooks T, Semper A, Manisty C, Treibel TA, Moon JC; UK COVIDsortium Investigators; Valdes AM, McKnight A, Altmann DM, Boyton R. Prior SARS-CoV-2 infection rescues B and T cell responses to variants after first vaccine dose. Science. 2021 Apr 30;372(6549):1418-23. doi: 10.1126/science.abh1282. Online ahead of print.
PubMed 33931567Commissioner O of the. Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. FDA. 2021; published online Aug 18. https://www.fda.gov/news-events/press-announcements/joint-statement-hhs-public-health-and-medical-experts-covid-19-booster-shots (accessed Aug 19, 2021).
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05710783
- Acronym / sponsor ID
- AVX-SARS-CoV-2-VAC-005
- Conditions
- SARS-CoV-2 Infection
- Keywords
- Newcastle Disease Virus, rNDV, COVID-19, SARS-Cov-2 Vaccine, Booster COVID-19 Vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,065 participants (actual)
- Lead sponsor
- Laboratorio Avi-Mex, S.A. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- National Council of Science and Technology, Mexico, Instituto Nacional de Enfermedades Respiratorias
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General objective:
To demonstrate immunogenicity and safety of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in previously vaccinated subjects and prove non-inferiority producing neutralizing antibodies anti-COVID-19 from 14 days after administration in comparison to the active control, whose efficacy has been formerly established in a placebo-controlled clinical study.
Primary objective:
Phase II:
To demonstrate immunogenicity of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot to increase levels of Spike protein to ACE2 binding-inhibitory antibodies, as well as to increase titres of neutralizing antibodies anti-COVID-19 from 14 days after vaccine administration.
Phase III:
To demonstrate non-inferiority of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot for seroconversion and production of neutralizing antibodies anti-COVID-19 from 14 days after vaccine administration compared to active control, whose efficacy has been formerly established in a placebo-controlled clinical study.
Secondary objectives:
Phase II:
To evaluate the extent of the increase in the neutralizing titres after 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot.
To evaluate production of interferon-gamma by peripheral blood T lymphocytes in response to the Spike protein or its derivatives peptides stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the study population.
To compare production of interferon-gamma by peripheral blood T lymphocytes in response to the Spike protein or its derivatives peptides stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the study population to production in subjects vaccinated with active control.
Phase III:
To document the incidence of symptomatic COVID-19 disease cases in both groups (experimental vaccine and active control) from 14 days after administration.
To document the incidence of severe or mortality COVID-19 disease cases in both groups (experimental vaccine and active control) from 14 days after administration.
Safety objective (primary):
Both Phases:
To evaluate safety of AVX/COVID-12 vaccine immunization as a single intramuscular booster shot in comparison to the active control.
Exploratory objectives:
Phase II:
To evaluate the extent of the increase in following neutralizing titres 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot as per the history of immunization/infection at the time of enrolment.
To evaluate the neutralizing capacity of anti-SARS-CoV-2 antibodies gained following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in neutralization tests of pseudovirus expressing Spike proteins derived from SARS-CoV-2 variants of concern.
To evaluate production of cytokines by peripheral blood T lymphocytes in response to the Spike protein or its derivatives (peptides) stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the population study.
To compare production of cytokines by peripheral blood T lymphocytes in response to the Spike protein or its derivatives (peptides) stimulation following 0, 14, 90 and 180 days of administration of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in a subgroup of subjects randomly selected among the population study to production in subjects vaccinated with active control.
Phase III:
To compare geometric means of neutralizing titres after AVX/COVID-12 (108.0 EID50/dose) vaccination as a single intramuscular booster shot in the following active-controlled subgroups:
- Subjects younger than 65 years.
- Subjects older than 65 years.
- Subjects with at least one comorbidity (any).
- Subjects with obesity (BMI >30).
- Subjects with Diabetes Mellitus.
- Subjects with hypertension.
- Subjects with smoking history.
- Subjects with asthma.
- Subjects with cardiovascular disease.
- Subjects with chronic obstructive pulmonary disease.
- Subjects with chronic renal disease.
- Subjects with liver disease.
- Subjects with cancer history.
Clinical trial hypothesis:
Phase II:
In subjects with prior anti-SARS-CoV-2 vaccination longer than 4 months ago, 14 days after intramuscular administration of the AVX/COVID-12 vaccine, ≥80% of the subjects showed an inhibitory capacity of the receptor-binding domain (spike protein binds to ACE2) above 95% and levels of neutralizing titres statistically greater than baseline tires (vaccination day).
Phase III:
Immunogenicity assessed as seroconversion rate and production of neutralizing antibodies after administration of the AVX/COVID-12 vaccine as a single intramuscular booster shot of 108.0 EID50/dose showed non-inferiority to active control from 14 days after administration.
Justification of the product use in clinical research.
Nonclinical studies and Phase I clinical study have shown safety of the AVX/COVID-12 vaccine by intramuscular route. Signs of immunogenicity in several animals are clear. Evaluation of the immune response in healthy volunteers in the Phase I clinical study after administration of the vaccine by intramuscular route as a single dose of 108.0 EID50/dose showed immunogenicity of the vaccine. Partial reports from a Phase II boosting study in subjects with low levels of immunity at the time of enrolment strongly suggest the vaccine is safe and immunogenic in this population. Altogether, these data justify the continuation of the AVX/COVID-12 vaccine development program. Due to the advanced stage of the pandemics and vaccination programs worldwide, it is important to assess the capacity of the AVX/COVID-12 vaccine to boost the pre-existing immunity in open previously vaccinated population.
Study design:
A phase II/III parallel, double-blind, active-controlled, non-inferiority study to evaluate immunogenicity and safety of a booster immunization scheme with 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.
Summarised description of Phase II design:
Subjects who meet the study inclusion and not exclusion criteria shall be randomised (1:1) to receive the AVX/COVID-12 vaccine or active control.
From the first 400 subjects of study samples corresponding to the efficacy criteria for Phases II and III shall be collected (including samples to determine cell response in a randomly-defined subgroup).
If at the end of the main endpoint assessment of the study phase corresponding to Phase II (day 14) it is determined the intervention with AVX-COVID-12 vaccine did not meet the specified objective (i. e., neutralizing capacity above 95% was not showed in 80% of the population vaccinated in surrogate testing and a significant change when comparing the geometric means of population neutralizing antibodies titres from days 0 to 14) the enrolment shall be stopped in order to meet the criteria related to the Phase III objectives, otherwise the enrolment shall continue consecutively.
Additionally, the first 400 subjects enrolled (corresponding to Phase II (200 vaccinated with the experimental vaccine and 200 with the active control)) shall be evaluated 90 and 180 days after vaccination to determine the humoral immune response performance at these moments.
A sub-sample of 100 subjects randomly selected (50 experimental vaccine and 50 active control) shall be evaluated regarding cell-mediated immune response in addition to the humoral response at the time of enrolment and 14, 90 and 180 days after vaccination.
Comparison of the safety evaluation related to Phase II shall be carried out with the population receiving active control as reference.
An interim futility analysis shall be carried out for non-inferiority criteria of Phase III at the end of enrolment corresponding to Phase II by Fleming-alpha spending function.
Summarised description of Phase III design:
In total 3832 subjects shall be enrolled divided into 3000 subjects to receive the experimental vaccine (2168 + 832 (632 Phase III + 200 from Phase II/III)) and 832 subjects (632 Phase II + 200 from Phase II/III) will receive active control.
The first 1664 subjects enrolled shall be randomised 1:1 to receive the experimental vaccine or active control and at the end of this phase the subsequent number of subjects enrolled shall receive only the experimental vaccine up to 3000 subjects.
From the first 1664 subjects of study (832 randomised to receive the experimental vaccine and 832 vaccinated with active control) samples shall be collected on days 0 and 14 to determine total titres of anti-S IgG, total titres of anti-N IgG and anti-SARS-CoV-2 neutralizing titres.
Three thousand subjects from safety population and 832 subjects vaccinated with active control shall be followed-up to 180 days to detect symptomatic cases of COVID-19 proved with genetic material detection from nasal/mouth mucus by PCR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
- Model description
- Immuno-bridging
| Arm | Type | Receives |
|---|---|---|
| Phase II - Experimental | Experimental | Biological: AVX-COVID/12AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response, Cellular response |
| Phase II - Active Control | Active comparator | Biological: ChAdOx-1-S[recombinant]ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response, Cellular response |
| Phase III - Experimental | Experimental | Biological: AVX-COVID/12AVX-COVID/12 Intramuscular Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response |
| Phase III - Active Control | Active comparator | Biological: ChAdOx-1-S[recombinant]ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response |
| Phase III - Security | Experimental | Biological: AVX-COVID/12AVX-COVID/12 Intramuscular Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety. |
| Phase II- Experimental | Experimental | Biological: AVX-COVID/12AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response. |
| Phase II- Active Control | Active comparator | –ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVX-COVID/12Also: Recombinant NDV Vectored Vaccine for SARS-CoV-2Single dose IM administration of a Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2 | Biological | Phase II - Experimental, Phase II- Experimental, Phase III - Experimental, Phase III - Security |
| ChAdOx-1-S[recombinant]Also: AstraZeneca COVID vaccineSingle dose IM administration of ChAdOx1 nCOV-19 (Astra-Zeneca) adenovirus-vectored vaccine | Biological | Phase II - Active Control, Phase III - Active Control |
Primary outcome
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Time frame: 14 to 17 days after vaccination
Serum IgG, neutralizing antibodies
Phase II - T-cell elicited responses
Time frame: Day 14
Percentage of cells expressing IL2, TNF-alpha and IFN-gamma by Flow cytometry after challenge with spike protein.
Phase III - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Time frame: 14 to 17 days after vaccination
Serum IgG, neutralizing antibodies
8 secondary outcomes
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Time frame: Day 0 (day of vaccination)
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Time frame: Day 90 after vaccination
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
Time frame: Day 180 after vaccination
Phase II - T-cell elicited responses
Time frame: Day 0 (day of vaccination)
Phase II - T-cell elicited responses
Time frame: Day 90 after vaccination
Phase II - T-cell elicited responses
Time frame: Day 180 after vaccination
Phase III - Incidence of symptomatic COVID-19 disease cases
Time frame: From 14 days after vaccination
Phase III - Incidence of severe COVID-19 disease cases or mortality
Time frame: From 14 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 34544278Lara-Puente JH, Carreno JM, Sun W, Suarez-Martinez A, Ramirez-Martinez L, Quezada-Monroy F, Paz-De la Rosa G, Vigueras-Moreno R, Singh G, Rojas-Martinez O, Chagoya-Cortes HE, Sarfati-Mizrahi D, Soto-Priante E, Lopez-Macias C, Krammer F, Castro-Peralta F, Palese P, Garcia-Sastre A, Lozano-Dubernard B. Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs. mBio. 2021 Oct 26;12(5):e0190821. doi: 10.1128/mBio.01908-21. Epub 2021 Sep 21.
- Background: PubMed 32896291Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.
- BackgroundDetermining Sample Sizes Needed to Detect a Difference between Two Proportions. In: Statistical Methods for Rates and Proportions. John Wiley & Sons, Ltd, 2003: 64-85.
- BackgroundRitchie H, Ortiz-Ospina E, Beltekian D, et al. Coronavirus Pandemic (COVID-19). Our World in Data 2020; published online March 5. https://ourworldindata.org/covid-cases (accessed Aug 2, 2021).
- BackgroundExceso de Mortalidad en México - Coronavirus. https://coronavirus.gob.mx/exceso-de-mortalidad-en-mexico/ (accessed Aug 2, 2021).
- Background: PubMed 34288409Dhillon P, Altmann D, Male V. COVID-19 vaccines: what do we know so far? FEBS J. 2021 Sep;288(17):4996-5009. doi: 10.1111/febs.16094. Epub 2021 Jul 19.
- Background: PubMed 34331459Zamai L, Rocchi MBL. Hypothesis: Possible influence of antivector immunity and SARS-CoV-2 variants on efficacy of ChAdOx1 nCoV-19 vaccine. Br J Pharmacol. 2022 Jan;179(2):218-226. doi: 10.1111/bph.15620. Epub 2021 Jul 31.
- Background: PubMed 34262158Barros-Martins J, Hammerschmidt SI, Cossmann A, Odak I, Stankov MV, Morillas Ramos G, Dopfer-Jablonka A, Heidemann A, Ritter C, Friedrichsen M, Schultze-Florey C, Ravens I, Willenzon S, Bubke A, Ristenpart J, Janssen A, Ssebyatika G, Bernhardt G, Munch J, Hoffmann M, Pohlmann S, Krey T, Bosnjak B, Forster R, Behrens GMN. Immune responses against SARS-CoV-2 variants after heterologous and homologous ChAdOx1 nCoV-19/BNT162b2 vaccination. Nat Med. 2021 Sep;27(9):1525-1529. doi: 10.1038/s41591-021-01449-9. Epub 2021 Jul 14.
- Background: PubMed 33691606He Q, Mao Q, An C, Zhang J, Gao F, Bian L, Li C, Liang Z, Xu M, Wang J. Heterologous prime-boost: breaking the protective immune response bottleneck of COVID-19 vaccine candidates. Emerg Microbes Infect. 2021 Dec;10(1):629-637. doi: 10.1080/22221751.2021.1902245.
- Background: PubMed 34260850Normark J, Vikstrom L, Gwon YD, Persson IL, Edin A, Bjorsell T, Dernstedt A, Christ W, Tevell S, Evander M, Klingstrom J, Ahlm C, Forsell M. Heterologous ChAdOx1 nCoV-19 and mRNA-1273 Vaccination. N Engl J Med. 2021 Sep 9;385(11):1049-1051. doi: 10.1056/NEJMc2110716. Epub 2021 Jul 14. No abstract available.
- Background: PubMed 34242571Hill JA, Ujjani CS, Greninger AL, Shadman M, Gopal AK. Immunogenicity of a heterologous COVID-19 vaccine after failed vaccination in a lymphoma patient. Cancer Cell. 2021 Aug 9;39(8):1037-1038. doi: 10.1016/j.ccell.2021.06.015. Epub 2021 Jun 26. No abstract available.
- Background: PubMed 34258322Velasco M, Galan MI, Casas ML, Perez-Fernandez E, Martinez-Ponce D, Gonzalez-Pineiro B, Castilla V, Guijarro C; Alcorcon COVID-19 Working Group. Impact of Previous Coronavirus Disease 2019 on Immune Response After a Single Dose of BNT162b2 Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine. Open Forum Infect Dis. 2021 Jun 4;8(7):ofab299. doi: 10.1093/ofid/ofab299. eCollection 2021 Jul.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data (including data dictionaries) will not be shared, but only to the extent permitted in the informed consent and under Mexican law.
Related trials for SARS-CoV-2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Peralta study director
Laboratorio Avi-Mex, S.A. de C.V.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AVX-COVID/12 and ChAdOx-1-S[recombinant] in people with SARS-CoV-2 Infection, run by Laboratorio Avi-Mex, S.A. de C.V. at 14 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum (time frame: 14 to 17 days after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710783, which also lists 60 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.