NCT05289206

Immune Response of an Interchangeable Booster Vaccine Against COVID-19 Among Individuals With Risk Factors for Severity

The Effects of the Interchangeability of the Booster Vaccine Against COVID-19 on the Immune Response Among Education and Public Safety Workers With Risk Factors for Severity, in Manaus (Amazonas)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,446 (actual)
• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Comorbidities and Coexisting Conditions
• Healthy

Interventions

Type	Name	Description
OTHER	Vaccine - ChAdOx1-S/nCoV-19 [recombinant]	ChAdOx1-S/nCoV-19 \[recombinant\] - 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

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-03-31
• Completion: 2022-05-30
• First posted: 2022-03-21
• Last updated: 2022-05-05

Locations

1 site across 1 country: Brazil