Status:
UNKNOWN
Immune Response of an Interchangeable Booster Vaccine Against COVID-19 Among Individuals With Risk Factors for Severity
Lead Sponsor:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM)
XP Investimentos
Conditions:
Comorbidities and Coexisting Conditions
Healthy
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief Summary
Experimental, single-arm study in participants with comorbidities, previously immunized with 2 doses of CoronaVac, who will receive a booster vaccine with 1 dose of the Oxford/AstraZeneca vaccine.
Detailed Description
Intervention: Oxford/AstraZeneca - 0.5 mL single dose, intramuscular in deltoid, with an interval of 180 days (+/- 30 days) from the 2nd dose of the initial vaccination schedule with CoronaVac Inclus...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Have voluntarily participated and be in regular follow-up monitoring by the COVACMANAUS study;
- Have completed the vaccination schedule with 2 doses of CoronaVac, as per the COVACMANAUS study protocol for at least 180 days (+/- 30 days);
- Demonstrate availability to be followed during the follow-up period defined in the study, through visits, telephone contacts or other digital means of communication;
- Accept to participate in this new study for 6 (six) months.
- Exclusion criteria
- Confirmed diagnosis of COVID-19 within the last 28 days (antigen test or RT-PCR). In this situation, vaccination can be postponed until the participant completes 30 days;
- Report of fever within 72 hours prior to vaccination (inclusion can be postponed until the participant completes 72 hours without fever and COVID-19 is discarded);
- Having received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study;
- Any other condition that, in the opinion of the Principal Investigator or its medical representative, could jeopardize the safety or rights of a potential participant or prevent them from complying with this protocol;
- Pregnancy or lactation.
Exclusion
Key Trial Info
Start Date :
September 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
4446 Patients enrolled
Trial Details
Trial ID
NCT05289206
Start Date
September 30 2021
End Date
May 30 2022
Last Update
May 5 2022
Active Locations (1)
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1
Fundação de Medicina Tropical Dr Heitor Vieira Dourado
Manaus, Amazonas, Brazil, 69040000