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Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence

NCT05205746 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-10-02

No results posted yet for this study

Summary

This is a Phase II study with single-blinded safety phase followed by double-blinded randomization, placebo-controlled, of administration of a single dose by two different administration routes (intramuscular route or intranasal route), to evaluate immunogenicity and safety of the recombinant SARS-CoV-2 vaccine (AVX/COVID-12 vaccine) based a live Newcastle disease viral vector (rNDV) in 396 healthy subjects with evidence of prior immunity to SARS-CoV-2, followed by a booster response assessment with an intramuscular dose of COVID-19 vaccine (ChAdOx-1 -S\[recombinant\]) in subjects originally randomized to the placebo arm at several research sites in Mexico City.

Conditions

  • SARS CoV 2 Infection

Interventions

BIOLOGICAL

Recombinant NDV Vectored Vaccine for SARS-CoV-2

Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

BIOLOGICAL

Placebo

Physiological saline solution of Sodium Chloride at 0.9% After mask opening ChAdOx-1-S\[recombinant\]) Intramuscular

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Instituto Nacional de Enfermedades Respiratorias

    collaborator OTHER_GOV

  • Laboratorio Avi-Mex, S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Laura Castro, MD · CAIMED Investigación en Salud S.A. de C.V.

  • Niels Hansen, MD · Unidad Médico Familiar No. 20 Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2022-08-09
Completion
2023-07-24

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205746 on ClinicalTrials.gov