Status:
COMPLETED
Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence
Lead Sponsor:
Laboratorio Avi-Mex, S.A. de C.V.
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Instituto Nacional de Enfermedades Respiratorias
Conditions:
SARS CoV 2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (intra...
Detailed Description
General objective: To demonstrate immunogenicity due to the administration of a single dose of AVX/COVID-12 vaccine at a dose of 108.0 EID50%/dose by the intramuscular or intranasal route in subjects...
Eligibility Criteria
Inclusion
- 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
- AstraZeneca
- CanSino
- Sinovac
- Sinopharm
- Johnson \& Johnson (Janssen)
- Sputnik V
Exclusion
- 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.
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2023
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05205746
Start Date
November 23 2021
End Date
July 24 2023
Last Update
October 2 2025
Active Locations (4)
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1
Centro Mexicano de Estudios Clínicos CEMDEC SA de CV
Mexico City, Mexico City, Mexico, 06100
2
CAIMED Investigación en Salud S.A. de C.V.
Mexico City, Mexico City, Mexico, 06760
3
Unidad Médico Familiar No. 20 Instituto Mexicano del Seguro Social
Mexico City, Mexico City, Mexico, 07760
4
Oaxaca Site Management Organization S.C.
Oaxaca City, Oaxaca, Mexico, 68000