Comorbidities and Coexisting ConditionsCOVACManaus2NCT05289206
Immune Response of an Interchangeable Booster Vaccine Against COVID-19 Among Individuals With Risk Factors for Severity
A study testing Vaccine - ChAdOx1-S/nCoV-19 [recombinant] in people with Comorbidities and Coexisting Conditions and Healthy, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Comorbidities and Coexisting Conditions, Healthy
- What is being tested?
- Vaccine - ChAdOx1-S/nCoV-19 [recombinant]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,446 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Sep 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fundação de Medicina Tropical Dr Heitor Vieira Dourado
Manaus, Amazonas, 69040000
About this study
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)
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.
Read the 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
- Being tested
- Vaccine - ChAdOx1-S/nCoV-19 [recombinant]
- Keywords
- Covid19, vaccine, ChAdOx1-S/nCoV-19 [recombinant]
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Vaccine - ChAdOx1-S/nCoV-19 [recombinant] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start30 Sep 2021
- Primary completion31 Mar 2022
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comorbidities and Coexisting ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 \[recombinant\]).
- Masking
- None (open label)
- Enrolment
- 4,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM), XP Investimentos, Universidade do Estado do Amazonas (UEA), Oswaldo Cruz Foundation
- Responsible party
- Sponsor
- Investigators
- Marcus Lacerda, PhD, Principal investigator, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289206
- Sponsor's protocol ID
- CAAE: 51701821.6.0000.0005
- Acronym
- COVACManaus2
- Status last verified
- May 2022
- First submitted
- 13 Sep 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05289206
- Acronym / sponsor ID
- COVACManaus2 / CAAE: 51701821.6.0000.0005
- Conditions
- Comorbidities and Coexisting Conditions, Healthy
- Keywords
- Covid19, vaccine, ChAdOx1-S/nCoV-19 [recombinant]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,446 participants (actual)
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira DouradoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM), XP Investimentos, Universidade do Estado do Amazonas (UEA), Oswaldo Cruz Foundation
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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]).
| Arm | Type | Receives |
|---|---|---|
| Intervention - single arm | Experimental | Other: Vaccine - ChAdOx1-S/nCoV-19 [recombinant]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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Intervention - single arm |
Primary outcome
Antibodies (detection and titration) against SARS-CoV-2 through quantitative test for total antibodies against viral nucleocapsid and IgG antibodies against Spike protein
Time frame: change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination
Detection and titration of antibodies against SARS-CoV-2 at baseline (Day 0) and at Day 90 and Day 180 after booster vaccination
5 secondary outcomes
Profile of the cell-mediated immune response in a subgroup of participants through cell immunophenotyping, using the Flow Cytometry (FC) technique.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Lacerda, PhD principal investigator
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine - ChAdOx1-S/nCoV-19 [recombinant] in people with Comorbidities and Coexisting Conditions and Healthy, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibodies (detection and titration) against SARS-CoV-2 through quantitative test for total antibodies against viral nucleocapsid and IgG antibodies against Spike protein (time frame: change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.