SARS-CoV-2 InfectionPhase 1/2NCT05133609
COVID-19 VACCINE SAFETY AND EFFECTIVENESS
A Phase 1/2 study testing ChAdOx1 nCoV-19 vaccine (AZD1222) in people with SARS-CoV-2 Infection, run by Federal University of Espirito Santo at 1 site in Brazil.
Trial summary
A longitudinal open-label study will include health professionals and patients with immune-mediated inflammatory diseases (IMID) who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- ChAdOx1 nCoV-19 vaccine (AZD1222)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2021to 30 Dec 2023
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
Who cannot join
- Pregnant women;
- History of severe adverse reaction to any previously administered vaccine;
- Having received another vaccine in the last 30 days.
- The criteria for vaccination in the immune-mediated inflammatory diseases (IMID) group will be in accordance with the Ministry of Health's National Immunization Program (PNI/MS).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Espirito Santo
Vitória, Espírito Santo, 29041-295
Valéria Valim, PhD, 2733157899, val.valim@gmail.com
José G Mill, PhD
About this study
A longitudinal open-label study will include health professionals and patients with immune-mediated inflammatory diseases (IMID) who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination campaign against SARS-CoV-2 to assess the safety, efficacy and duration of the short- and long-term humoral and cellular immune response after vaccination for COVID-19 and compare the vaccine response between individuals who have or have not had previous SARS-Cov 2 infection.
Read the detailed description
A longitudinal open-label study that will include individuals who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination campaign against SARS-CoV-2 to assess the safety, efficacy and duration of the short- and long-term humoral and cellular immune response after vaccination for COVID- 19 and compare the vaccine response between individuals who have or have not had previous SARS-Cov 2 infection. Health professionals (HS) and patients with immune-mediated inflammatory diseases (IMID) who participate in vaccination campaigns at the Cassiano Antônio Mores da University Hospital will be included. Federal University of Espírito Santo (HUCAM-UFES). It is intended to include 200 health workers and 350 patients with IMID, totaling 550 participants. Participants who have had previous SARS-CoV-2 infection confirmed by RT-PCR or positive PRNT at baseline will be considered a group exposed to COVID-19 (CovPrev) and the group without previous infection will be considered a control group (Naive). The IMID group will include patients with Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Spondyloarthritis (SA), Sjögren's Syndrome (SS), Psoriasis (Pso), Inflammatory Bowel Disease (IBD) and Vasculitis (VASC) who complete validated international classification criteria for each disease. The criteria for vaccination in the IMID group will be in accordance with the National Immunization Program of the Ministry of Health (PNI/MS). Adverse events will be recorded during the first, second and fourth week, and through weekly telephone contacts until D40. The evaluations and collection of biological samples will be carried out in 5 moments (D0, D14 and D28 after the first dose; D28 after the second dose; and D28 after thrid dose) to evaluate the efficacy and in 3 moments (D180, D360 and D540), to evaluate the duration of immunity. Neutralization tests by plaque reduction (PRNT) will be performed to detect neutralizing antibodies against COVID-19, determination of the profile of specific IgM, IgA and IgG, dosage of systemic soluble factors (chemokines, cytokines and growth factors), characterization of phenotypes of immunoregulation, immunosenescence, cell activation and exhaustion and antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The study hypothesis is that vaccine-induced production of neutralizing antibodies is more effective in individuals with previous natural SARS-Cov2 infection and less in immunosuppressed individuals.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- ChAdOx1 nCoV-19 vaccine (AZD1222)
- Keywords
- vaccines, immunity, safety, rheumatic diseases, covid-19
- Medical subject headings
- COVID-19, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1 nCoV-19 vaccine (AZD1222)Biological
ChAdOx1 nCoV-19 vaccine (AZD1222) in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-third dose).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Health professionals who will receive vaccine in the vaccination campaign against SARS-CoV-2. Receives: Biological: ChAdOx1 nCoV-19 vaccine (AZD1222) |
| Group 2 | Experimental | Patients with immune-mediated inflammatory diseases who will receive vaccine in the vaccination campaign against SARS-CoV-2. Receives: Biological: ChAdOx1 nCoV-19 vaccine (AZD1222) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Neutralization Assay
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title > 1:50 will be considered positive.
Measured: 7 months
Viral Neutralization Assay
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title > 1:50 will be considered positive.
Measured: 24 months
Secondary outcomes (27)
IgM (Immunoglobulin M)
Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.
Measured: 7 months
IgM (Immunoglobulin M)
Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.
Measured: 24 months
IgG (Immunoglobulin G)
Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.
Measured: 7 months
IgG (Immunoglobulin G)
Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.
Measured: 24 months
IgA (Immunoglobulin G)
Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.
Measured: 7 months
IgA (Immunoglobulin G)
Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.
Measured: 24 months
systemic soluble factors
Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.
Measured: 7 months
systemic soluble factors
Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.
Measured: 24 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 1 month
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 6 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 12 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 18 months
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 1 month
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 6 months
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 12 months
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 18 months
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 1 month
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 6 months
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 12 months
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Measured: 18 months
Adverse events
All adverse events will be followed up to establish severity and causal correlation. There will be surveillance of deaths and will be reported to the ethics committee.
Measured: 1 month
Adverse events
All adverse events will be followed up to establish severity and causal correlation. There will be surveillance of deaths and will be reported to the ethics committee.
Measured: 4 months
Adverse events
All adverse events will be followed up to establish severity and causal correlation. There will be surveillance of deaths and will be reported to the ethics committee.
Measured: 6 months
severe cases of COVID-19
incidence of severe cases of COVID-19 over 20 months following treatment
Measured: 24 months
deaths
Number of deaths with specific ICD for covid-19
Measured: 24 months
hospital admissions
number of hospital admissions for covid-19
Measured: 24 months
intensive care unit (ICU) admissions
number of intensive care unit (ICU) admissions for the treatment of SARS
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start15 Jan 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Espirito Santo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto René Rachou (IRR)
- Responsible party
- Principal investigator, Valéria Valim, Federal University of Espirito Santo
- Investigators
- Valéria Valim, PhD, Principal investigator, Federal University of Espirito Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133609
- Sponsor's protocol ID
- FUES03
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 24 Nov 2021
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 VACCINE SAFETY AND EFFECTIVENESS
- ClinicalTrials.gov ID
- NCT05133609
- Acronym / sponsor ID
- FUES03
- Conditions
- SARS-CoV-2 Infection
- Keywords
- vaccines, immunity, safety, rheumatic diseases, covid-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Federal University of Espirito SantoUniversity, hospital or other
- Collaborators
- Instituto René Rachou (IRR)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 24 Nov 2021 (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.
A longitudinal open-label study will include health professionals and patients with immune-mediated inflammatory diseases (IMID) who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination campaign against SARS-CoV-2 to assess the safety, efficacy and duration of the short- and long-term humoral and cellular immune response after vaccination for COVID-19 and compare the vaccine response between individuals who have or have not had previous SARS-Cov 2 infection.
Detailed description
A longitudinal open-label study that will include individuals who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination campaign against SARS-CoV-2 to assess the safety, efficacy and duration of the short- and long-term humoral and cellular immune response after vaccination for COVID- 19 and compare the vaccine response between individuals who have or have not had previous SARS-Cov 2 infection. Health professionals (HS) and patients with immune-mediated inflammatory diseases (IMID) who participate in vaccination campaigns at the Cassiano Antônio Mores da University Hospital will be included. Federal University of Espírito Santo (HUCAM-UFES). It is intended to include 200 health workers and 350 patients with IMID, totaling 550 participants. Participants who have had previous SARS-CoV-2 infection confirmed by RT-PCR or positive PRNT at baseline will be considered a group exposed to COVID-19 (CovPrev) and the group without previous infection will be considered a control group (Naive). The IMID group will include patients with Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Spondyloarthritis (SA), Sjögren's Syndrome (SS), Psoriasis (Pso), Inflammatory Bowel Disease (IBD) and Vasculitis (VASC) who complete validated international classification criteria for each disease. The criteria for vaccination in the IMID group will be in accordance with the National Immunization Program of the Ministry of Health (PNI/MS). Adverse events will be recorded during the first, second and fourth week, and through weekly telephone contacts until D40. The evaluations and collection of biological samples will be carried out in 5 moments (D0, D14 and D28 after the first dose; D28 after the second dose; and D28 after thrid dose) to evaluate the efficacy and in 3 moments (D180, D360 and D540), to evaluate the duration of immunity. Neutralization tests by plaque reduction (PRNT) will be performed to detect neutralizing antibodies against COVID-19, determination of the profile of specific IgM, IgA and IgG, dosage of systemic soluble factors (chemokines, cytokines and growth factors), characterization of phenotypes of immunoregulation, immunosenescence, cell activation and exhaustion and antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The study hypothesis is that vaccine-induced production of neutralizing antibodies is more effective in individuals with previous natural SARS-Cov2 infection and less in immunosuppressed individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: ChAdOx1 nCoV-19 vaccine (AZD1222)Health professionals who will receive vaccine in the vaccination campaign against SARS-CoV-2. |
| Group 2 | Experimental | Biological: ChAdOx1 nCoV-19 vaccine (AZD1222)Patients with immune-mediated inflammatory diseases who will receive vaccine in the vaccination campaign against SARS-CoV-2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older
Key exclusion criteria (4 listed)
- Pregnant women;
- History of severe adverse reaction to any previously administered vaccine;
- Having received another vaccine in the last 30 days.
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 |
|---|---|---|
| ChAdOx1 nCoV-19 vaccine (AZD1222)ChAdOx1 nCoV-19 vaccine (AZD1222) in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-third dose). | Biological | Group 1, Group 2 |
Primary outcome
Viral Neutralization Assay
Time frame: 7 months
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title > 1:50 will be considered positive.
Viral Neutralization Assay
Time frame: 24 months
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title > 1:50 will be considered positive.
27 secondary outcomes
IgM (Immunoglobulin M)
Time frame: 7 months
IgM (Immunoglobulin M)
Time frame: 24 months
IgG (Immunoglobulin G)
Time frame: 7 months
IgG (Immunoglobulin G)
Time frame: 24 months
IgA (Immunoglobulin G)
Time frame: 7 months
IgA (Immunoglobulin G)
Time frame: 24 months
systemic soluble factors
Time frame: 7 months
systemic soluble factors
Time frame: 24 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Time frame: 1 month
Antigen-specific stimulation of peripheral blood mononuclear cells
Time frame: 6 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Time frame: 12 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Time frame: 18 months
Lymphocyte investigation
Time frame: 1 month
Lymphocyte investigation
Time frame: 6 months
Lymphocyte investigation
Time frame: 12 months
Lymphocyte investigation
Time frame: 18 months
Cytokine investigation
Time frame: 1 month
Cytokine investigation
Time frame: 6 months
Cytokine investigation
Time frame: 12 months
Cytokine investigation
Time frame: 18 months
Adverse events
Time frame: 1 month
Adverse events
Time frame: 4 months
Adverse events
Time frame: 6 months
severe cases of COVID-19
Time frame: 24 months
deaths
Time frame: 24 months
hospital admissions
Time frame: 24 months
intensive care unit (ICU) admissions
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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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.
Valéria Valim, PhD principal investigator
Federal University of Espirito Santo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ChAdOx1 nCoV-19 vaccine (AZD1222) in people with SARS-CoV-2 Infection, run by Federal University of Espirito Santo 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 1 inclusion and 4 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 24 Nov 2021. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Valéria Valim, PhD (+5527999874665, val.valim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Neutralization Assay (time frame: 7 months). The study lists 2 primary outcomes in all. 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 24 Nov 2021.