Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM) | UNKNOWN |
| XP Investimentos | UNKNOWN |
| Universidade do Estado do Amazonas (UEA) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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:
Exclusion criteria
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - single arm | Experimental | Oxford/AstraZeneca (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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine - ChAdOx1-S/nCoV-19 [recombinant] | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibodies (detection and titration) against SARS-CoV-2 through quantitative test for total antibodies against viral nucleocapsid and IgG antibodies against Spike protein | Detection and titration of antibodies against SARS-CoV-2 at baseline (Day 0) and at Day 90 and Day 180 after booster vaccination | change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of the cell-mediated immune response in a subgroup of participants through cell immunophenotyping, using the Flow Cytometry (FC) technique. | • Profile of the cell-mediated immune response in a subgroup of participants, before (D0), at D90 and D180 after booster vaccination through cell immunophenotyping, using the Flow Cytometry (FC) technique. Memory T and B cell subpopulations will be labeled with monoclonal antibodies conjugated to pre-especified fluorochromes that bind to specific surface markers (clusters of differentiation) present in the populations of interest. |
Not provided
Inclusion criteria:
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcus Lacerda, PhD | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundação de Medicina Tropical Dr Heitor Vieira Dourado | Manaus | Amazonas | 69040000 | Brazil |
Not provided
| Oswaldo Cruz Foundation |
| OTHER |
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]).
Not provided
Not provided
Not provided
Not provided
| change from baseline profile (Day 0) of the cell-mediated immune response compared to Day 90 (D90) and Day 180 (D180) after booster vaccination |
| 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 | • Ability to neutralize antibodies in a subgroup of participants, through the Viral Neutralization Test (VNT) consisting of cultured Vero CCL-81 cells, inactivated serial diluted serum and fixation. | 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 |
| Quantification of memory cell populations in a subgroup of participants | • Profile of memory populations by cellular immunophenotyping in a subgroup of participants at baseline (Day 0) and in Day 90 and Day 180 after booster vaccination. | change from baseline (Day 0) memory cell populations in a subgroup of participants at Day 90 (D90) and Day 180 (D180) after booster vaccination |
| Physical activity and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2. | • Detection and titration of antibodies against SARS-CoV-2 and relationship with the history of physical activity during the follow-up period. To access physical activity the International Physical Activity Questionnaire (IPAQ) will be used and combined with the Duke Activity Status Index (DASI) questionnaire for sedentary lifestyle. | 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 |
| Sedentary lifestyle and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2. | • Detection and titration of antibodies against SARS-CoV-2 and relationship with the history of sedentary lifestyle during the follow-up period. To access the sedentary lifestyle the Duke Activity Status Index (DASI) questionnaire will be used and combined with International Physical Activity Questionnaire (IPAQ) for physical activity. | 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 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided