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New COVID booster vaccine shows promise in large trial

NCT ID NCT05710783

Vaccine Sponsor: Laboratorio Avi-Mex, S.A. de C.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new COVID-19 booster vaccine called AVX/COVID-12, made from a modified Newcastle disease virus (which affects birds). Over 4,000 healthy adults in Mexico who had already been vaccinated against COVID-19 received either the new vaccine or the AstraZeneca booster. The goal was to see if the new vaccine triggers a similar immune response and is safe. The trial is now complete, and results are being analyzed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AVX/COVID-12 vaccine (made from a modified Newcastle disease virus)
What this could lead to
If successful, this could provide a new booster option against COVID-19 that is safe and effective.
What could go wrong
This is a completed trial, but results are not yet published. The vaccine uses a novel virus vector, so its long-term performance is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

4,065 people

The number who actually took part.

Started

Nov 2022

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2 infection

Contacts and locations

Locations

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

    Mexico City, Mexico City, 06760, Mexico

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

    Mérida, Yucatán, 97070, Mexico

  • Centro de Investigación Clínica Acelerada, S.C.

    Gustavo Adolfo Madero, Mexico City, 07369, Mexico

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

    Coyoacán, Mexico City, 04100, Mexico

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

    Acapulco de Juárez, Guerrero, 39670, Mexico

  • Centro de Investigación y Avances Médicos Especializados / RED OSMO Cancún

    Cancún, Quintana Roo, 77506, Mexico

  • Clinical Research Institute S.C.

    Tlalnepantla, State of Mexico, 54055, Mexico

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

    Mérida, Yucatán, 97070, Mexico

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, Oaxaca, 68000, Mexico

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

    Veracruz, Veracruz, 91855, Mexico

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

    Aguascalientes, Aguascalientes, 20230, Mexico

  • Sociedad Administradora de Servicios de Salud, S.C.

    Morelia, Michoacán, 58260, Mexico

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

    Mérida, Yucatán, 97070, Mexico

  • Unidad de Medicina Familiar No. 20 - IMSS

    Gustavo Adolfo Madero, Mexico City, 07760, Mexico

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