Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT05289206
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
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.
Type of study/study design: 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.
Sample size: all active participants from the COVACManaus study (up to 5071)
Primary outcome: Detection and titration of antibodies against SARS-CoV-2 before (D0), at D90 and D180 after booster vaccination
Secondary outcomes:
* Profile of the cell-mediated immune response in a subgroup of participants, before (D0), at D90 and D180 after booster vaccination;
* Ability to neutralize antibodies in a subgroup of participants before (D0), in D90 and D180 after the vaccine booster;
* Memory cell populations in a subgroup of participants before (D0), in D90 and D180 after booster vaccination.
* Detection and titration of antibodies against SARS-CoV-2 and its association with the history of physical activity or sedentary lifestyle.
Study:
NCT05289206
Study Brief:
Protocol Section:
NCT05289206