Laboratorio Avi Mex SA de CV

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.

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.

This is a Phase 1, open-label, non-randomized, dose-escalation study using three doses and two schemes of administration of a recombinant vaccine against SARS-CoV-2 based on a viral vector (Newcastle Disease virus) in 90 healthy volunteers at a single research site in Mexico City.