Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster.
SARS-CoV-2 Infection
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring Newcastle Disease Virus, rNDV, COVID-19, SARS-Cov-2 Vaccine, Booster COVID-19 Vaccine
Eligibility Criteria
Inclusion Criteria: People ≥18 years old. Any genre. Have received their informed consent. Negative PCR test for SARS-CoV-2 during the screening visit. Negative pregnancy test in women with child-bearing potential. 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). Have been vaccinated with any of the approved vaccines against SARS-CoV-2 (at least once). Exclusion Criteria: History of hypersensibility or allergy to any of the vaccine compounds. History of severe anaphylactic reactions of any cause. Fever at the baseline visit. Active participation in any other clinical trial or experimental intervention within last 3 months. Have received any vaccine (experimental or approved) within 30 days before baseline visit, except for influenza vaccine. The last anti-COVID vaccination was less than 4 months ago. SARS-CoV-2 infection occurred in less than 1 month ago. Pregnant or nursing women. 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). Chronic diseases that require use of immunosuppressive agents or immune response modulators (for instance: systemic corticosteroids, cyclosporine, rituximab, among others). Cancer under active chemotherapy treatment. Subjects with HIV infection history. 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.
Sites / Locations
- CAIMED Investigación en Salud S.A. de C.V.
- Centro de Investigación Clínica Chapultepec S.A. de C.V.
- Unidad de Medicina Familiar No. 20 - IMSS
- Centro de Investigación Clínica Acelerada, S.C.
- Clinical Research Institute S.C.
- Centro de Investigación Clínica del Pacífico, S.A. de C.V.
- Sociedad Administradora de Servicios de Salud, S.C.
- Centro de Investigación y Avances Médicos Especializados / RED OSMO Cancún
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clinica en Yucatán S.C.P.
- Jules Bordet Medical Service, S.C.P. / Khöler & Milstein Research
- Unidad de Atención Médica e Investigación en Salud, S.C.P.
- Promotora Médica Aguascalientes, S.A. de C.V.
- Oaxaca Site Management Organization, S.C.
- Profesionales Médicos Desarrollados, S.C. (Instituto Veracruzano de Investigación Clínica)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Phase II - Experimental
Phase II - Active Control
Phase III - Experimental
Phase III - Active Control
Phase III - Security
Phase II- Experimental
Phase II- Active Control
AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response, Cellular response
ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response, Cellular response
AVX-COVID/12 Intramuscular Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response
ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response
AVX-COVID/12 Intramuscular Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety.
AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response.
ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response.