COVID-19 Vaccines Clinical Trial
Official title:
Randomised Phase II Study to Assess the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schedules (rAd26-rAd5, rAd26-rAd26, rAd26-ChAdOx1 and rAd26-mRNA-1273).
Verified date | August 2021 |
Source | Ministerio de Salud de Ciudad Autónoma de Buenos Aires |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 persons aged 21 to 65 years
Status | Active, not recruiting |
Enrollment | 348 |
Est. completion date | September 6, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - Persons who have received a dose of Gam-COVID-Vac more than 30 days and: - Age > 21 and <66 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Ministerio de Salud de la Ciudad Autónoma de Buenos Aires | Ciudad Autonoma de Buenos Aires | CBA |
Argentina | Ministerio de Salud de la Ciudad Autónoma de Buenos Aires | Ciudad Autónoma de Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Ministerio de Salud de Ciudad Autónoma de Buenos Aires |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ELISA assessment of concentration of IgG anti Spike (UI/ml) at 28 days. | To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with currently used counterpart regimens.
The assessment of the antibody concentration in each of the study arms will be measured by measuring the IgG antibody concentration using ELISA expressed in IU/ml. Additionally, geometric mean concentration ratio will be measured comparing the ratio between Sputnik vaccination and that obtained in each study arm. |
28 days | |
Primary | Serious adverse events Adverse events of special interest | To report the combine and specific rate of serious adverse defined as death for any reason, any life-threatening event or any event that require inpatient hospitalization. | 28 days | |
Secondary | Neutralising antibodies against SARS-CoV-2 | Neutralising antibody titres at baseline, 14 days and 28 days after randomisation will be measured in all participants. | 28 days |
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