Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes in an Elderly Population

• Status: Recruiting
• Trial end date: 2021-09-26
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with counterpart regimens currently in use in Argentina among a population of persons aged 66 or above.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ministerio de Salud de Ciudad Autónoma de Buenos Aires

Criteria

Inclusion Criteria:

• Persons who have received a dose of Gam-COVID-Vac more than 30 days and less than 90 days ago.

• Age > 65 years.

• Both genders.

• Who have voluntarily agreed to participate in the clinical trial and have provided informed consent.

Exclusion Criteria:

• Known history of COVID in the 6 months prior to study inclusion.

• Known or suspected immunocompromised status by the study investigator for any cause.

• Use of oral or parenteral corticosteroids in the last 30 days.

• Known history of allergy to any vaccine.

• History of anaphylaxis.

• Pregnant or lactating women.

• Known history of autoimmune diseases.

• Persons under treatment for any neoplastic disease within the last 6 months.

• Any serious illness or condition at the discretion of the study investigator (including but not limited to the presence of chronic obstructive pulmonary disease, heart failure, poorly controlled hypertension, poorly controlled diabetes, renal failure).

• Planned medical procedures within two months of randomisation.

• Previous vaccination within the last 30 days with any vaccine.

• Known participation in an ongoing clinical trial.

• Ongoing acute illness.

• Fever (≥37.8 C) at the time of randomisation.