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

NCT05205746 | Completed Phase 2 DMC

• 1 other identifier: AVX-SARS-CoV-2-VAC-002
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Newcastle Disease Virus; rNDV; COVID-19; SARS-Cov-2 Vaccine; Booster COVID-19 Vaccine

Outcome Measures

Primary Outcomes (2)

• Titers of circulating anti SARS-CoV-2 antibodies

  Serum IgG, neutralizing antibodies

  Day 14

• T-cell elicited responses

  Percentage of cells expressing IL2, TNFalpha and IFNgamma by Flow cytometry after challenge with spike protein

  Day 14

Secondary Outcomes (8)

• Titers of circulating anti SARS-CoV-2 antibodies

  Day 0

• Titers of circulating anti SARS-CoV-2 antibodies

  Day 42

• Titers of circulating anti SARS-CoV-2 antibodies

  Day 90

• Titers of circulating anti SARS-CoV-2 antibodies

  Day 180

• Titers of circulating anti SARS-CoV-2 antibodies

  Day 365

Other Outcomes (25)

• Safety: adverse events

  Day 1

• Safety: adverse events

  Day 2

• Safety: adverse events

  Day 3

Study Arms (4)

Intramuscular

EXPERIMENTAL

10 8.0 EID 50/dose intramuscular

Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2

Intranasal

EXPERIMENTAL

10 8.0 EID 50/dose intranasal

Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2

Intramuscular Placebo

OTHER

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

Biological: Placebo

Intranasal Placebo

OTHER

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

Biological: Placebo

Interventions

Recombinant NDV Vectored Vaccine for SARS-CoV-2 BIOLOGICAL

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

Intramuscular; Intranasal

Placebo BIOLOGICAL

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

Intramuscular Placebo; Intranasal Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥ 18 years old.
• Indistinct sex.
• Having given their informed consent.
• No respiratory problems during the last 21 days prior to administration of the single dose.
• No conditions or alterations in the physical examination, laboratory values and cabinet that in the opinion of the investigator may interfere with the participation of the subject in the study or require a more detailed medical study.
• Negative PCR test for SARS-CoV-2 during the screening visit.
• Negative pregnancy test in women with pregnancy potential.
• Signature of commitment for the use of highly effective contraceptive methods for at least 30 days after administration of the intramuscular injection or intranasal.
• In case of presenting any chronic disease with medical management, it must be controlled and stable without changes in treatment during the last three months prior to the scrutiny visit.
• Commitment to maintain adequate prevention measures to avoid the contagion by SARS-CoV-2 during their participation in the study, considering themselves these strict use during the first 14 days after the baseline visit (Use of face masks in closed places, social distancing measures in spaces open, and frequent hand washing).
• Present detectable titers of anti-Spike IgG in peripheral serum during the visit of screening with titers less than 1,200 U/mL in a chemiluminescence test.
• Submit proof of vaccination 4 months or more after the last vaccination
• Have been vaccinated with the complete program of any of the following vaccines against SARS-CoV-2:
• ModeRNA
• Pfizer

You may not qualify if:

• History of hypersensitivity or allergy to any of the components of the vaccine.
• History of severe anaphylactic reactions from any cause.
• History of seizures.
• Uncontrolled chronic diseases.
• Chronic diseases that require management with immunosuppressive agents or immune response modulators (eg, systemic corticosteroids, cyclosporine, rituximab among others).
• Oncological disease.
• Active participation, or during the last 3 months in any other clinical study or research experimental intervention.
• Use within 30 days prior to screening evaluation of any drug or herbal supplement, or alternative medicine (for example, transfer factor, chlorine dioxide, etc.) aimed at treating or preventing complications or contagion by SARS-CoV-2, or any other condition.
• Febrile illness at the time of the screening visit.
• Have received any vaccine (experimental or approved) during the 60 days prior to the scrutiny visit.
• Having received a blood transfusion or blood components during the last 4 months prior to the scrutiny hearing.
• Have been a plasma donor during the last 4 months prior to the visit of scrutiny.
• Have undergone dialysis or hemodialysis procedures during the last year prior to the scrutiny visit.
• Work on poultry or gamecock farms.
• History of substance abuse problems that in the opinion of the investigator could interfere with the subject's ability to adequately comply with the protocol guidelines.

Sponsors & Collaborators

• Laboratorio Avi-Mex, S.A. de C.V.: lead
• National Council of Science and Technology, Mexico: collaborator
• Instituto Nacional de Enfermedades Respiratorias: collaborator

Study Sites (4)

Centro Mexicano de Estudios Clínicos CEMDEC SA de CV

Mexico City, Mexico City, 06100, Mexico

Location

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

Mexico City, Mexico City, 06760, Mexico

Location

Unidad Médico Familiar No. 20 Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 07760, Mexico

Location

Oaxaca Site Management Organization S.C.

Oaxaca City, Oaxaca, 68000, Mexico

Location

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura Castro, MD

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

  PRINCIPAL INVESTIGATOR

• Niels Hansen, MD

  Unidad Médico Familiar No. 20 Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The first sentinel group (6 of each previous vaccine) will be without masked only to the subjects to ensure safety measurement in each group. The randomized double-mask placebo-controlled phase will begin when the safety committee, after evaluating the information from the sentinel group of the first three subjects (by vaccine and by specific route of administration), gives authorization to continue with the recruitment. It will be conducted through a computerized assignment system. Randomization for the double-masking phase of the study will be carried out using a computer assignment system.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be assigned according to their previous vaccine.

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: January 25, 2022
• Study Start: November 23, 2021
• Primary Completion: August 9, 2022
• Study Completion: July 24, 2023
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available immediately following publication and for 12 months thereafter.
• Access Criteria: Data will be available only to investigators whose proposed use of the data has been authorized by an independent review committee and the ethics committees involved in the authorization of the protocol, and/or the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) in Mexico if required by law. The permitted use of the data will be as authorized. Proposals or requests should be directed to gustavo.peralta@avimex.com.mx and authorized data requestors must sign a data access agreement.

Locations

ME (4)