Clinical trial NCT05289206: Immune Response of an Interchangeable Booster Vaccine Against COVID-19 Among Individuals With Risk Factors for Severity
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Comorbidities and Coexisting Conditions
Healthy
Keywords: Covid19
vaccine
ChAdOx1-S/nCoV-19 [recombinant]
Lead sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM)
name: XP Investimentos
name: Universidade do Estado do Amazonas (UEA)
name: Oswaldo Cruz Foundation
First posted: 2022-03-21
Enrollment: 4446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 (ChAdOx1-S/nCoV-19 \[recombinant\]).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antibodies (detection and titration) against SARS-CoV-2 through quantitative test for total antibodies against viral nucleocapsid and IgG antibodies against Spike protein
timeFrame: change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination
Secondary outcomes:
measure: Profile of the cell-mediated immune response in a subgroup of participants through cell immunophenotyping, using the Flow Cytometry (FC) technique.
timeFrame: change from baseline profile (Day 0) of the cell-mediated immune response compared to Day 90 (D90) and Day 180 (D180) after booster vaccination
measure: Ability of the serum from a subgroup of participants to neutralize antibodies though viral neutralization assay at baseline (Day 0) and at Day 90 and D180 after vaccine booster dose
timeFrame: change from baseline (Day 0) profile of the ability to neutralize antibodies in a subgroup of participants at Day 90 (D90) and Day 180 (D180) after booster vaccination
measure: Quantification of memory cell populations in a subgroup of participants
timeFrame: change from baseline (Day 0) memory cell populations in a subgroup of participants at Day 90 (D90) and Day 180 (D180) after booster vaccination
measure: Physical activity and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2.
timeFrame: change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination and it relationship with the history of physical activity
measure: Sedentary lifestyle and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2.
timeFrame: change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination and it relationship with the history of sedentary lifestyle
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Fundação de Medicina Tropical Dr Heitor Vieira Dourado
state: Amazonas
Study officials:
affiliation: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
name: Marcus Lacerda, PhD
role: PRINCIPAL_INVESTIGATOR
References: