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

NCT05710783
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Phase
Phase 2/Phase 3
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Recruitment status
Completed
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Participants
4,065
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Lead sponsor
Laboratorio Avi-Mex, S.A. de C.V.
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Start date
2022-11-09
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Number of sites
14
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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.
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Short title
Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster.
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2023-09-10
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First posted
2023-02-02
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Registry last updated
2025-10-02
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Primary completion date
2022-12-28
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Start date
2022-11-09
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Actual participants
4,065
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Participants
4,065
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Participant count basis
Actual
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Protocol amendments
2
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Randomisation ratio
1:1
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Number of sites
14
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Laboratorio Avi-Mex, S.A. de C.V.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05710783
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ClinicalTrials.gov ID
NCT05710783
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Registry record
Open registry record
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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
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  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).

  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
clinicaltrials.gov

  • 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
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And 35 more, listed on the interactive page.

Sources for references
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Related records

Drugs (2)

Collaborators (2)

Lead sponsors (1)

Conditions (1)

Targets (2)