Could different settings of immunodysfunction have an impact on COVID-19 disease burden, case fatality ratio and immune response following COVID-19 disease or vaccination?
| ISRCTN | ISRCTN12126664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12126664 |
| Secondary identifying numbers | INV_215 |
- Submission date
- 09/10/2021
- Registration date
- 11/10/2021
- Last edited
- 07/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The pandemic caused by the new SARS-CoV2 coronavirus identified poses the greatest health challenge of the 21st century. More than one year after its appearance, there is still no treatment capable of inducing a cure, and prospects for controlling the pandemic are based on prevention through vaccination with recently developed vaccines.
In SARS-CoV2 infection, the immune response, clinical evolution, contagiousness, and prognosis seem to be influenced by the presence of immunosuppression (the state in which your immune system is not functioning as well as it should). Vaccine efficacy in immunosuppressed patients has not yet been fully characterized. Immunosuppression seems to be associated with a higher death rate, longer duration of infection, and a longer period of contagiousness, enabling these patients to act as a replicative viral reservoir for long periods of time.
The ongoing mass vaccination campaign against SARS-CoV2 infection provides a unique opportunity to assess vaccine response in immunosuppressed patients, particularly people living with HIV (PLWH) and immune-mediated inflammatory diseases (IMIDs) patients. International recommendations regarding COVID-19 vaccination in immunosuppressed patients have been recently updated, acknowledging the need for a booster dose in these patients. We believe that response to vaccination may be one reliable indicator of the degree of immune dysfunction and may translate the inability to protect against infection. We will combine an infection survey with a study on cellular immunity to further characterize vaccine responsiveness in immunosuppressed patients.
Who can participate?
Adult HIV patients and IMIDs patients on immunosuppressive treatment.
What does the study involve?
Clinical data will be registered (past and present medical history, results of exams, and treatments) by consulting clinical files.
Patients will be asked to attend medical appointments and medical examinations proposed, including taking blood samples.
Blood samples will be collected on admission and at various times over a 12-18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19.
What are the possible benefits and risks of participating?
This study will not have a direct influence on patients' clinical disease status but will allow us to better understand the SARS-COV2 infection, contributing to the care of future patients and medical investigation.
Taking blood samples may cause discomfort or a slight bruise.
No other invasive interventions will be performed; the standard of care of patients at our hospital will not be affected by this study.
Where is the study run from?
The study is run from the Infectious Diseases and Auto-immune Departments of Centro Hospitalar Universitário Lisboa Central, in collaboration with Instituto Gulbenkian de Ciência.
When is the study starting and how long is it expected to run for?
The study is starting in October 2021 and is expected to run for 12-18 months.
Who is funding the study?
This is an investigator initiated study promoted by the Portuguese public hospital Centro Hospitalar Universitário Lisboa Central.
Roche Diagnostics provided the kits necessary for the determination of serology.
The study on cellular immunity will be done in collaboration with Instituto Gulbenkian de Ciência (Portugal)
Who is the main contact?
Diana Póvoas, diana.silva@chlc.min-saude.pt
Contact information
Scientific
Infectious Diseases Unit
Hospital de Curry Cabral
Rua da Beneficência, 8
Lisbon
1050-099
Portugal
 ORCID ID |
0000-0003-4531-2123 |
|---|---|
| Phone | +351 217924280 |
| diana.silva@chlc.min-saude.pt |
Public
Infectious Diseases Unit
Hospital de Curry Cabral
Rua da Beneficência, 8
Lisbon
1050-'99
Portugal
| Phone | +351 217924280 |
|---|---|
| diana.silva@chlc.min-saude.pt |
Study information
| Study design | Single-centre prospective observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 40532 PIS.pdf |
| Scientific title | Seroepidemiological survey and study of cellular immunity against SARS-CoV2 in immunocompromised patients |
| Study objectives | Immune response following SARS-CoV2 infection and/or vaccination is influenced by immune dysfunction in immunosuppressed patients |
| Ethics approval(s) | Approved 18/06/2021, Ethics Committee for Health of Central Lisbon University Hospital Centre (Centro Hospitalar Universitário Lisboa Central [CHULC], Rua José António Serrano, 1150-199 Lisbon, Portugal; +351-213514410; comissao.etica@chlc.min-saude.pt), ref: 1073/2021 |
| Health condition(s) or problem(s) studied | Influence of different settings of immune dysfunction in immunosuppressed patients on antibody and cellular immune responses following SARS-CoV2 infection and/or COVID-19 vaccination. |
| Intervention | Vaccines will be administered according to the Portuguese national vaccination plan against COVID-19, the investigation team won’t be responsible for decision-making regarding vaccine type and brand, timing, and place of vaccination Clinical data will be registered (past and present medical history, results of exams, and treatments) by consulting clinical files. Patients will be asked to attend medical appointments and medical examinations proposed, including taking blood samples. Blood samples will be collected on admission and at various times over a 12 - 18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Comirnaty® (Pfizer); COVID-19 Vaccine Moderna®; VAXZEVRIA® (AstraZeneca), COVID-19 Vaccine Janssen® |
| Primary outcome measure | Determination of antibodies to the SARS-CoV-2 nucleoprotein (N) and spike (S) protein receptor binding domain SARS-CoV2 will be by electrochemiluminescence using Elecsys-N and Elecsys-S (Roche Diagnostics) and these results will be expressed in U/mL, using blood samples collected on admission and at various times over a 12 - 18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19 |
| Secondary outcome measures | Using blood samples collected on admission and at various times over a 12 - 18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19: 1. Measurement of SARS-CoV2 specific reactive CD8+ T cell response using spheromers (Mallajosyula V, et al. 2021) 2. Assessment of SARS-CoV-2 specific memory B cells responses through a flow cytometric assay using a combination of fluorescently labeled antigens as probes to track the induction of virus-specific memory B cells in longitudinal peripheral blood mononuclear cell (PBMC) samples (Goel RR, et al. 2021) |
| Overall study start date | 18/06/2021 |
| Completion date | 21/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 252 |
| Total final enrolment | 203 |
| Key inclusion criteria | 1. Adult patients with HIV infection 2. Adult patients with immune-mediated inflammatory disease on immunosuppressive therapies |
| Key exclusion criteria | 1. Refusal to give informed consent 2. Contraindication to venipuncture |
| Date of first enrolment | 13/10/2021 |
| Date of final enrolment | 31/07/2022 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Lisbon
1150-199
Portugal
Sponsor information
Hospital/treatment centre
Rua José António Serrano
Lisbon
1150-199
Portugal
| Phone | +351 21 884 1000 |
|---|---|
| centro.investigacao@chlc.min-saude.pt | |
| Website | http://www.chlc.min-saude.pt/homepage.aspx?menuid=1 |
"ROR" |
https://ror.org/00k6r3f30 |
Funders
Funder type
Other
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Roche Diagnostics Corporation
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Portuguese | 11/10/2021 | No | Yes |
Additional files
- 40532 PIS.pdf
- in Portuguese
Editorial Notes
07/12/2022: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 01/11/2022 to 31/07/2022.
3. The intention to publish date was changed from 01/01/2023 to 01/05/2023.
11/10/2021: Trial's existence confirmed by Ethics Committee for Health of Central Lisbon University Hospital Centre
