Immunocompromised PatientsPhase 3COVERALLNCT04805125
Immunocompromised Swiss Cohorts Based Trial Platform
A Phase 3 study testing Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) and Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®) in people with Immunocompromised Patients, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
Trial summary
This study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study [SHCS] and Swiss Transplant Cohort Study [STCS]) to assess the comparative effectiveness and safety of approved SARS-CoV-2 vaccines in immunocompromised patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompromised Patients
- What is being tested?
- Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) and Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 19 Apr 2021to 23 Sep 2023
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients registered with informed consent from participating cohorts aged ≥18 years
- Additional consent for participation in the specific sub-protocol trial
- All patients with either a chronic HIV infection or recipients of solid organs registered with informed consent from the SHCS and STCS cohorts aged ≥18 years
- Patients with solid organ transplantation of lungs or kidneys at least one month post-transplantation with a prednisone dose of 20mg or less.
- Covid-19 vaccination recommended by treating physician
- Inclusion criteria for 2. sub protocol (observational study):
- Third covid-19 vaccination recommended by treating physician and administered in the frame of clinical routine
- Patients receiving a new bivalent (Wuhan/Omicron BA.1) mRNA SARS-CoV-2 vaccine in the frame of clinical routine, according to the treating physician
Who cannot join
- Acute symptomatic SARS-CoV-2 infection, influenza or other acute respiratory tract infection
- Known allergy or contra-indications for vaccines or any vaccine components
- Any emergency condition requiring immediate hospitalization for any condition
- Patients with previous PCR documented SARS-CoV-2 infection and, or documented antibodies less than 3 months prior to screening visit (day 0)
- Pregnancy
- Acute symptomatic SARS-CoV-2 infection, influenza or other acute respiratory tract infection
Show all 14Show fewer
- Known allergy or contra-indications for vaccines or any vaccine components
- Any emergency condition requiring immediate hospitalization for any condition
- Patients with previous PCR documented SARS-CoV-2 infection and, or documented antibodies less than 3 months prior to randomisation
- Patients with solid organ transplantation (lung or kidney) with the following conditions:
- Solid organ transplant recipients less than one month post-transplantation
- Solid organ transplant recipients with the use of T-cell/B-cell depleting agents in the last 3 months (i. e induction treatment in standard risk or high-risk immunological situation or rejection treatment).
- Solid organ transplant recipients with the need of pulse corticosteroids (>100mg prednisone or equivalent) in the last 1 month or who have received ATG or rituximab in the last 6 months
- Solid organ transplant recipients with the need of any kind of chemotherapy treatment
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
University Hospital Basel
Basel, 4031
University Hospital Bern
Bern, 3010
University Hospital Lausanne CHUV
Lausanne, 1011
University Hospital Zurich
Zurich, 8091
About this study
Official title: Randomised Controlled Trials to Assess Approved SARS-CoV-2 Vaccines in Immunocompromised Patients: A Master Protocol for the Set-up of a Swiss Cohorts Based Trial Platform
This study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study [SHCS] and Swiss Transplant Cohort Study [STCS]) to assess the comparative effectiveness and safety of approved SARS-CoV-2 vaccines in immunocompromised patients.
This platform will be tested in the frame of an exploratory pilot trial and a framework will be set up to conduct a larger, flexible, randomized controlled trial (RCT) to test approved SARS-CoV-2 vaccines to prevent SARS-CoV-2 infections.
Read more
The first sub-protocol for a pilot trial is to investigate the operability of a platform trial that is nested into two existing cohort studies and compare immune response, safety and clinical efficacy of the first two mRNA vaccines (Comirnaty® by Pfizer / BioNTech and COVID-19 mRNA Vaccine Moderna®, by Moderna) in immune compromised patients in the Swiss HIV and Swiss Transplant Cohort studies.
The second sub-protocol (observational study) is to collect a blood sample before the third vaccination and 8 weeks after vaccination to analyze an additional benefit of a third SARS-CoV-2 vaccine in these immunocompromised patients.
In the third sub-protocol (substudy-3; observational) we will recruit patients who have received m-RNA-1273.214 by Moderna in the frame of clinical routine. We will start a second arm of our observational study as soon as another bivalent mRNA vaccine (from Pfizer-BioNTech) has been approved by Swissmedic. We aim to compare the immunologic response and safety of the bivalent mRNA-1273.214 vaccine from Moderna among immunocompromised persons (persons living with HIV or kidney or lung transplant recipients) to the immunologic response of immunocompromised persons who received the bivalent mRNA vaccine from Pfizer-BioNTech.
Read the detailed description
The aim of this study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study [SHCS] and Swiss Transplant Cohort Study [STCS]) to assess the comparative effectiveness and safety of approved SARS-CoV-2 vaccines in immunocompromised patients. Nesting this trial into cohorts with highly standardized data collection allows for a rapid, efficient and cost-saving trial conduct.
This platform will be tested in the frame of a pilot trial and a framework will be set up to conduct a larger, flexible, randomized controlled trial (RCT) to test approved SARS-CoV-2 vaccines to prevent SARS-CoV-2 infections.
The pilot study will primarily assess the functionality of the trial platform and early immunogenicity, efficacy and safety data. At a later stage, the platform might also be used to enlarge the pilot trial or to develop sub-protocols to deal with patients with no or insufficient immune response to Sars-CoV-2 vaccines.
Since January 12, 2021 two mRNA vaccines against Sars-CoV-2 by Pfizer / BioNTech (Comirnaty®) and COVID-19 mRNA Vaccine Moderna® by Moderna have been licensed in Switzerland and roll-out of vaccines has started
The first sub-protocol for a pilot trial is to investigate the operability of a platform trial that is nested into two existing cohort studies and compare immune response, safety and clinical efficacy of the first two mRNA vaccines (Comirnaty® by Pfizer / BioNTech and COVID-19 mRNA Vaccine Moderna®, by Moderna) in immune compromised patients in the Swiss HIV and Swiss Transplant Cohort studies.
In Switzerland, since October 2021 severely immunodeficient persons ≥ 12 years of age who have received two doses of an mRNA vaccine should receive a third dose of Comirnaty® or Spikevax® as part of the basic immunization, regardless of any antibody titer. Among all other immunocompromised patients a booster vaccination with an mRNA vaccine is recommended. These vaccines will be administered to patients from the SHCS and the STCS in the frame of clinical routine.
This second sub-protocol (observational study) is to collect a blood sample before the third vaccination and 8 weeks after vaccination to analyze an additional benefit of a third SARS-CoV-2 vaccine in these immunocompromised patients.
In the third sub-protocol (substudy-3; observational) we will recruit patients who have received m-RNA-1273.214 by Moderna in the frame of clinical routine. We will start a second arm of our observational study as soon as another bivalent mRNA vaccine (from Pfizer-BioNTech) has been approved by Swissmedic. We aim to compare the immunologic response and safety of the bivalent mRNA-1273.214 vaccine from Moderna (n=160) among immunocompromised persons (persons living with HIV or kidney or lung transplant recipients) to the immunologic response of immunocompromised persons who received the bivalent mRNA vaccine from Pfizer-BioNTech (n=80). Patients will be asked to provide blood sample at baseline (before receiving bivalent mRNA SARS-CoV-2 vaccine) and 4 weeks, 8 weeks, and 6 months after vaccination (see details in original study protocol below).
- Conditions
- Immunocompromised Patients
- Being tested
- Moderna COVID-19 Vaccine, mRNA-1273 (100 μg), Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)
- Keywords
- Covid-19 infection, SARS-CoV-2-specific antibodies, Sars-CoV-2 vaccine, vector based messenger ribonucleic acid (mRNA) vaccines, SARS-CoV-2 infection, Swiss HIV Cohort Study [SHCS], Swiss Transplant Cohort Study [STCS], BNT162b2, mRNA-1273, bivalent SARS-CoV-2 vaccine, mRNA-1273.214
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderna COVID-19 Vaccine, mRNA-1273 (100 μg)Biological
intramuscular injection, proposed as a series of two doses (0.5 mL each), dosing is 100 microgram on day 0 and day 28
Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)Biological
intramuscular injection, proposed dosing is 30 microgram of the diluted vaccine solution (0.3 mL each) on day 0 and day 21
| Study group | Role | What they receive |
|---|---|---|
| Moderna mRNA COVID-19 vaccine | Active comparator | The Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) is administered intramuscularly as a series of two doses (0.5 mL each), given 28 days apart.
ARM CLOSED Receives: Biological: Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) |
| Comirnaty® (Pfizer / BioNTech) mRNA COVID-19 vaccine | Active comparator | Active:
The comparator product is the first licensed vaccine against SARS-CoV-2 in Switzerland.
Pfizer-BioNTech COVID-19 Vaccine, BNT162b2 (30 µg) Comirnaty®, is administered intramuscularly (IM) as a series of two 30 µg doses of the diluted vaccine solution (0.3 mL each) according to the following schedule: a single dose followed by a second dose 21 days later.
ARM CLOSED Receives: Biological: Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunological outcome: change in pan-Ig antibody response (pan-Ig anti-S1-RBD)
A commercial immunoassay Elecsys® Anti-SARS-CoV-2 S for the in vitro quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma is used. This assay detects pan-Ig antibody response (pan-Ig anti-S1-RBD) and allows for a quantitative assessment of the serological response of the participants.
Measured: at baseline (day of vaccination) and three months after vaccination
immunological outcome: change in anti-Nucleocapsid (N) response
Qualitative measurement of anti-Nucleocapsid (N) responses with Elecsys® Anti-SARS-CoV-2 N assay
Measured: at baseline (day of vaccination) and three months after vaccination
immunological outcome: change in SARS-CoV-2-binding antibodies
SARS-CoV-2-binding antibody responses of the participants are assessed by analyzing the IgM, IgA and IgG responses to a wider range of SARS-CoV-2 proteins (S1, S2, RBD and N) using an in-house method (ABCORA). The ABCORA test allows a parallel assessment of IgG, IgM and IgA reactivity.
Measured: at baseline (day of vaccination) and three months after vaccination
Number of participants with newly polymerase chain reaction (PCR)-confirmed asymptomatic COVID-19 infection
Number of participants with newly PCR-confirmed asymptomatic COVID-19 infection (identified by the presence of anti-SARS-CoV-2 nucleocapsid antibodies or Sars-Cov-2 PCR or rapid antigen test) and no related symptoms [(i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose nausea or vomiting, and diarrhea])
Measured: at any time point in within 48 weeks following randomisation (day of vaccination)
Number of participants with newly PCR-confirmed symptomatic COVID-19 infection
Number of participants with newly PCR-confirmed symptomatic COVID-19 infection with at least one of the following symptoms (i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose nausea or vomiting, and diarrhea
Measured: at any time point in within 48 weeks following randomisation (day of vaccination)
Number of participants with severe COVID-19 infection
Number of participants with severe COVID-19 infection with respiratory failure, evidence of shock (as diagnosed by a treating physician), clinically significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death
Measured: at any time point in within 48 weeks following randomisation (day of vaccination)
Clinical Outcome: COVID-19 burden of diseases (BOD)
COVID-19 burden of diseases (BOD), a composite, will be scored as by using 0 for no COVID-19, 1 for non-severe COVID-19, and 2 for severe COVID-19.
Measured: within 48 weeks following randomisation (day of vaccination)
Duration of RCT set up (specific endpoint related to trial conduct feasibility)
Duration of RCT set up (i.e. time from deciding which interventions will be tested until the first patient is randomised).
Measured: one time assessment at baseline (from deciding which interventions will be tested until the first patient is randomised)
Time of patient recruitment from activation of first study site until 40 patients are randomised
Time of patient recruitment from activation of first study site until 40 patients are randomised
Measured: one time assessment after approx. 3 months (from activation of first study site until 40 patients are randomised)
Time of patient recruitment from activation of first study site until 380 patients are randomised
Time of patient recruitment from activation of first study site until 380 patients are randomised
Measured: one time assessment after approx. 3 months (from activation of first study site until 380 patients are randomised)
Patient consent rate
Patient consent rate (i.e. proportion of patients giving informed consent out of approached eligible patients)
Measured: approx. 3 months
Proportion of missing data for all baseline variables from routinely collected cohort data
Proportion of missing data for all baseline variables from routinely collected cohort data
Measured: one time assessment at baseline
Proportion of missing data for all clinical outcomes
Proportion of missing data for all clinical outcomes from routinely collected cohort data and outcome data that is collected in the trial platform
Measured: one time assessment after approx. 3 months
SARS-CoV-2-specific antibodies
SARS-CoV-2-specific antibodies (using a pan-IgG antibody assay against the receptor binding domain (RBD) against the nP and spike 1 subunits)
Measured: three months after vaccination
SARS-CoV-2-specific titers
SARS-CoV-2-specific titers (using an in-house assay developed by the Institute of Medical Virology, University of Zurich which can detect multiple viral epitopes)
Measured: three months after vaccination
The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed in the observational second sub- protocol
The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed or plasma assessed in the observational second sub- protocol by the commercial immunoassay Elecsys Anti-SARS-CoV-2 S (Elecsys S) from Roche Diagnostics. An antibody response will be considered as positive using the threshold ≥ 100 units/ml, predicting a protective immune response.
Measured: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Secondary outcomes (6)
The proportion of patients with a positive antibody response using SARS-CoV-2 spike (S1) Elecsys S by Roche in the observational second sub- protocol, using a threshold of ≥0.8 units/ml as defined by the manufacturer
The proportion of patients with a positive antibody response using SARS-CoV-2 spike (S1) Elecsys S by Roche in the observational second sub- protocol, using a threshold of ≥0.8 units/ml as defined by the manufacturer
Measured: 8 weeks (¨+/- 2 weeks) after 3. vaccination
The proportion of patients with a positive antibody response using antibody response using the Antibody CORonavirus Assay (ABCORA) 2 in the observational second sub- protocol
The proportion of patients with a positive antibody response using antibody response using the Antibody CORonavirus Assay (ABCORA) 2 in the observational second sub- protocol that assesses seropositivity by measuring specific IgG, IgA and IgM responses to SARS-CoV-2 receptor binding domains, S1, S2 and N16
Measured: 8 weeks (¨+/- 2 weeks) after 3. vaccination
The proportion of patients with neutralizing neutralization activity against the vaccine strain Wuhan-Hu-1 in the observational second sub- protocol
The proportion of patients with neutralizing neutralization activity against the vaccine strain Wuhan-Hu-1 in sera in the observational second sub- protocol defined as having an ABCORA sum S1 (sum of S1 signal over cut-off values of IgG, IgA, IgM) above the threshold of 17.
Measured: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Immune response (pan-Ig antibodies against the receptor binding domain (RBD) in the S1 subunit of the spike protein (pan-Ig anti-S1-RBD) of SARS-CoV-2 in the observational second sub- protocol
Immune response (pan-Ig antibodies against the receptor binding domain (RBD) in the S1 subunit of the spike protein (pan-Ig anti-S1-RBD) of SARS-CoV-2 in the observational second sub- protocol
Measured: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Mean immune response of IgM, IgA and IgG to the subunit S1 using ABCORA in the observational second sub- protocol
Mean immune response of IgM, IgA and IgG to the subunit S1 using ABCORA in the observational second sub- protocol
Measured: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Number of newly PCR-confirmed asymptomatic SARS-CoV-2 infection in the observational second sub- protocol
Number of newly PCR-confirmed asymptomatic SARS-CoV-2 infection in the observational second sub- protocol
Measured: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start19 Apr 2021
- Primary completion23 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Immunocompromised PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort embedded platform with a first sub-study pilot trial of two arms comparing licensed vaccines against SARS-CoV-2. The platform design allows to expand the pilot trial into a larger trial by sub-protocols to add or drop vaccine arms or to add further sub-protocols for re-randomization of patients with no immune response to a vaccine booster or new vaccines A parallel two-arm open-label randomized controlled exploratory pilot trial comparing the first in Switzerland approved SARS-CoV-2 vaccines (based on a trial platform that is integrated into the ongoing routine prospective data collection of two national cohorts, the SHCS and STCS). Within substudy-2 and substudy-3 observational studies were added to the platform trial.
- Masking
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, ModernaTX, Inc.
- Responsible party
- Sponsor
- Investigators
- Heiner C. Bucher, Prof. Dr. med., Principal investigator, Basel Institute for Clinical Epidemiology & Biostatistics, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805125
- Sponsor's protocol ID
- 2021-000593; me20Bucher
- Acronym
- COVERALL
- Status last verified
- Jan 2024
- First submitted
- 15 Mar 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Speich B, Chammartin F, Abela IA, Amico P, Stoeckle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Audige A, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Trkola A, Briel M, Kusejko K, Bucher HC; Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Antibody Response in Immunocompromised Patients After the Administration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine BNT162b2 or mRNA-1273: A Randomized Controlled Trial. Clin Infect Dis. 2022 Aug 24;75(1):e585-e593. doi: 10.1093/cid/ciac169.
PubMed 35234868Kusejko K, Chammartin F, Smith D, Odermatt M, Schuhmacher J, Koller M, Gunthard HF, Briel M, Bucher HC, Speich B; Swiss HIV Cohort Study; Swiss Transplant Cohort Study. Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients. BMC Infect Dis. 2022 Jul 28;22(1):654. doi: 10.1186/s12879-022-07621-x.
PubMed 35902817Amstutz A, Chammartin F, Audige A, Eichenberger AL, Braun DL, Amico P, Stoeckle MP, Hasse B, Papadimitriou-Olivgeris M, Manuel O, Bongard C, Schuurmans MM, Hage R, Damm D, Tamm M, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Schonenberger CM, Griessbach A, Labhardt ND, Kouyos RD, Trkola A, Kusejko K, Bucher HC, Abela IA, Briel M, Speich B; Swiss HIV Cohort Study; Swiss Transplant Cohort. Antibody and T-Cell Response to Bivalent Booster SARS-CoV-2 Vaccines in People With Compromised Immune Function: COVERALL-3 Study. J Infect Dis. 2024 Oct 16;230(4):e847-e859. doi: 10.1093/infdis/jiae291.
PubMed 38848312Griessbach A, Chammartin F, Abela IA, Amico P, Stoeckle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Audige A, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Trkola A, Epp S, Amstutz A, Schonenberger CM, Taji Heravi A, Papadimitriou-Olivgeris M, Casutt A, Manuel O, Kusejko K, Bucher HC, Briel M, Speich B; Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Antibody Response After the Third SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients and People Living With HIV (COVERALL-2). Open Forum Infect Dis. 2023 Nov 3;10(11):ofad536. doi: 10.1093/ofid/ofad536. eCollection 2023 Nov.
PubMed 38023564Chammartin F, Griessbach A, Kusejko K, Audige A, Epp S, Stoeckle MP, Eichenberger AL, Amstutz A, Schoenenberger CM, Hasse B, Braun DL, Rauch A, Trkola A, Briel M, Bucher HC, Gunthard HF, Speich B, Abela IA; Swiss HIV Cohort Study. Bridging the gap: identifying factors impacting mRNA severe acute respiratory syndrome coronavirus 2 vaccine booster response in people with HIV-1. AIDS. 2024 Feb 1;38(2):217-222. doi: 10.1097/QAD.0000000000003751. Epub 2023 Oct 11.
PubMed 37830908Chammartin F, Kusejko K, Pasin C, Trkola A, Briel M, Amico P, Stoekle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Mueller NJ, Rauch A, Koller MT, Gunthard HF, Bucher HC, Speich B, Abela IA; and the Swiss HIV Cohort Study. Determinants of antibody response to severe acute respiratory syndrome coronavirus 2 mRNA vaccines in people with HIV. AIDS. 2022 Aug 1;36(10):1465-1468. doi: 10.1097/QAD.0000000000003246. Epub 2022 Jul 9.
PubMed 35876706Speich B, Chammartin F, Smith D, Stoeckle MP, Amico P, Eichenberger AL, Hasse B, Schuurmans MM, Muller T, Tamm M, Dickenmann M, Abela IA, Trkola A, Hirsch HH, Manuel O, Cavassini M, Hemkens LG, Briel M, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Bucher HC, Kusejko K; study groups from the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty(R) and COVID-19 mRNA Vaccine Moderna(R). Trials. 2021 Oct 21;22(1):724. doi: 10.1186/s13063-021-05664-0.
PubMed 34674742
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trials to Assess Approved SARS-CoV-2 Vaccines in Immunocompromised Patients: A Master Protocol for the Set-up of a Swiss Cohorts Based Trial Platform
- ClinicalTrials.gov ID
- NCT04805125
- Acronym / sponsor ID
- COVERALL / 2021-000593; me20Bucher
- Conditions
- Immunocompromised Patients
- Keywords
- Covid-19 infection, SARS-CoV-2-specific antibodies, Sars-CoV-2 vaccine, vector based messenger ribonucleic acid (mRNA) vaccines, SARS-CoV-2 infection, Swiss HIV Cohort Study [SHCS], Swiss Transplant Cohort Study [STCS], BNT162b2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, ModernaTX, Inc.
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 18 Mar 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.
This study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study [SHCS] and Swiss Transplant Cohort Study [STCS]) to assess the comparative effectiveness and safety of approved SARS-CoV-2 vaccines in immunocompromised patients.
This platform will be tested in the frame of an exploratory pilot trial and a framework will be set up to conduct a larger, flexible, randomized controlled trial (RCT) to test approved SARS-CoV-2 vaccines to prevent SARS-CoV-2 infections.
The first sub-protocol for a pilot trial is to investigate the operability of a platform trial that is nested into two existing cohort studies and compare immune response, safety and clinical efficacy of the first two mRNA vaccines (Comirnaty® by Pfizer / BioNTech and COVID-19 mRNA Vaccine Moderna®, by Moderna) in immune compromised patients in the Swiss HIV and Swiss Transplant Cohort studies.
The second sub-protocol (observational study) is to collect a blood sample before the third vaccination and 8 weeks after vaccination to analyze an additional benefit of a third SARS-CoV-2 vaccine in these immunocompromised patients.
In the third sub-protocol (substudy-3; observational) we will recruit patients who have received m-RNA-1273.214 by Moderna in the frame of clinical routine. We will start a second arm of our observational study as soon as another bivalent mRNA vaccine (from Pfizer-BioNTech) has been approved by Swissmedic. We aim to compare the immunologic response and safety of the bivalent mRNA-1273.214 vaccine from Moderna among immunocompromised persons (persons living with HIV or kidney or lung transplant recipients) to the immunologic response of immunocompromised persons who received the bivalent mRNA vaccine from Pfizer-BioNTech.
Detailed description
The aim of this study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study [SHCS] and Swiss Transplant Cohort Study [STCS]) to assess the comparative effectiveness and safety of approved SARS-CoV-2 vaccines in immunocompromised patients. Nesting this trial into cohorts with highly standardized data collection allows for a rapid, efficient and cost-saving trial conduct.
This platform will be tested in the frame of a pilot trial and a framework will be set up to conduct a larger, flexible, randomized controlled trial (RCT) to test approved SARS-CoV-2 vaccines to prevent SARS-CoV-2 infections.
The pilot study will primarily assess the functionality of the trial platform and early immunogenicity, efficacy and safety data. At a later stage, the platform might also be used to enlarge the pilot trial or to develop sub-protocols to deal with patients with no or insufficient immune response to Sars-CoV-2 vaccines.
Since January 12, 2021 two mRNA vaccines against Sars-CoV-2 by Pfizer / BioNTech (Comirnaty®) and COVID-19 mRNA Vaccine Moderna® by Moderna have been licensed in Switzerland and roll-out of vaccines has started
The first sub-protocol for a pilot trial is to investigate the operability of a platform trial that is nested into two existing cohort studies and compare immune response, safety and clinical efficacy of the first two mRNA vaccines (Comirnaty® by Pfizer / BioNTech and COVID-19 mRNA Vaccine Moderna®, by Moderna) in immune compromised patients in the Swiss HIV and Swiss Transplant Cohort studies.
In Switzerland, since October 2021 severely immunodeficient persons ≥ 12 years of age who have received two doses of an mRNA vaccine should receive a third dose of Comirnaty® or Spikevax® as part of the basic immunization, regardless of any antibody titer. Among all other immunocompromised patients a booster vaccination with an mRNA vaccine is recommended. These vaccines will be administered to patients from the SHCS and the STCS in the frame of clinical routine.
This second sub-protocol (observational study) is to collect a blood sample before the third vaccination and 8 weeks after vaccination to analyze an additional benefit of a third SARS-CoV-2 vaccine in these immunocompromised patients.
In the third sub-protocol (substudy-3; observational) we will recruit patients who have received m-RNA-1273.214 by Moderna in the frame of clinical routine. We will start a second arm of our observational study as soon as another bivalent mRNA vaccine (from Pfizer-BioNTech) has been approved by Swissmedic. We aim to compare the immunologic response and safety of the bivalent mRNA-1273.214 vaccine from Moderna (n=160) among immunocompromised persons (persons living with HIV or kidney or lung transplant recipients) to the immunologic response of immunocompromised persons who received the bivalent mRNA vaccine from Pfizer-BioNTech (n=80). Patients will be asked to provide blood sample at baseline (before receiving bivalent mRNA SARS-CoV-2 vaccine) and 4 weeks, 8 weeks, and 6 months after vaccination (see details in original study protocol below).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort embedded platform with a first sub-study pilot trial of two arms comparing licensed vaccines against SARS-CoV-2. The platform design allows to expand the pilot trial into a larger trial by sub-protocols to add or drop vaccine arms or to add further sub-protocols for re-randomization of patients with no immune response to a vaccine booster or new vaccines A parallel two-arm open-label randomized controlled exploratory pilot trial comparing the first in Switzerland approved SARS-CoV-2 vaccines (based on a trial platform that is integrated into the ongoing routine prospective data collection of two national cohorts, the SHCS and STCS). Within substudy-2 and substudy-3 observational studies were added to the platform trial.
| Arm | Type | Receives |
|---|---|---|
| Moderna mRNA COVID-19 vaccine | Active comparator | Biological: Moderna COVID-19 Vaccine, mRNA-1273 (100 μg)The Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) is administered intramuscularly as a series of two doses (0.5 mL each), given 28 days apart. ARM CLOSED |
| Comirnaty® (Pfizer / BioNTech) mRNA COVID-19 vaccine | Active comparator | Biological: Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)Active: The comparator product is the first licensed vaccine against SARS-CoV-2 in Switzerland. Pfizer-BioNTech COVID-19 Vaccine, BNT162b2 (30 µg) Comirnaty®, is administered intramuscularly (IM) as a series of two 30 µg doses of the diluted vaccine solution (0.3 mL each) according to the following schedule: a single dose followed by a second dose 21 days later. ARM CLOSED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients registered with informed consent from participating cohorts aged ≥18 years
- Additional consent for participation in the specific sub-protocol trial
- All patients with either a chronic HIV infection or recipients of solid organs registered with informed consent from the SHCS and STCS cohorts aged ≥18 years
- Patients with solid organ transplantation of lungs or kidneys at least one month post-transplantation with a prednisone dose of 20mg or less.
- Covid-19 vaccination recommended by treating physician
Key exclusion criteria (14 listed)
- Acute symptomatic SARS-CoV-2 infection, influenza or other acute respiratory tract infection
- Known allergy or contra-indications for vaccines or any vaccine components
- Any emergency condition requiring immediate hospitalization for any condition
- Patients with previous PCR documented SARS-CoV-2 infection and, or documented antibodies less than 3 months prior to screening visit (day 0)
- Pregnancy
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 |
|---|---|---|
| Moderna COVID-19 Vaccine, mRNA-1273 (100 μg)intramuscular injection, proposed as a series of two doses (0.5 mL each), dosing is 100 microgram on day 0 and day 28 | Biological | Moderna mRNA COVID-19 vaccine |
| Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)intramuscular injection, proposed dosing is 30 microgram of the diluted vaccine solution (0.3 mL each) on day 0 and day 21 | Biological | Comirnaty® (Pfizer / BioNTech) mRNA COVID-19 vaccine |
Primary outcome
immunological outcome: change in pan-Ig antibody response (pan-Ig anti-S1-RBD)
Time frame: at baseline (day of vaccination) and three months after vaccination
A commercial immunoassay Elecsys® Anti-SARS-CoV-2 S for the in vitro quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma is used. This assay detects pan-Ig antibody response (pan-Ig anti-S1-RBD) and allows for a quantitative assessment of the serological response of the participants.
immunological outcome: change in anti-Nucleocapsid (N) response
Time frame: at baseline (day of vaccination) and three months after vaccination
Qualitative measurement of anti-Nucleocapsid (N) responses with Elecsys® Anti-SARS-CoV-2 N assay
immunological outcome: change in SARS-CoV-2-binding antibodies
Time frame: at baseline (day of vaccination) and three months after vaccination
SARS-CoV-2-binding antibody responses of the participants are assessed by analyzing the IgM, IgA and IgG responses to a wider range of SARS-CoV-2 proteins (S1, S2, RBD and N) using an in-house method (ABCORA). The ABCORA test allows a parallel assessment of IgG, IgM and IgA reactivity.
Number of participants with newly polymerase chain reaction (PCR)-confirmed asymptomatic COVID-19 infection
Time frame: at any time point in within 48 weeks following randomisation (day of vaccination)
Number of participants with newly PCR-confirmed asymptomatic COVID-19 infection (identified by the presence of anti-SARS-CoV-2 nucleocapsid antibodies or Sars-Cov-2 PCR or rapid antigen test) and no related symptoms [(i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose nausea or vomiting, and diarrhea])
Number of participants with newly PCR-confirmed symptomatic COVID-19 infection
Time frame: at any time point in within 48 weeks following randomisation (day of vaccination)
Number of participants with newly PCR-confirmed symptomatic COVID-19 infection with at least one of the following symptoms (i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose nausea or vomiting, and diarrhea
Number of participants with severe COVID-19 infection
Time frame: at any time point in within 48 weeks following randomisation (day of vaccination)
Number of participants with severe COVID-19 infection with respiratory failure, evidence of shock (as diagnosed by a treating physician), clinically significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death
Clinical Outcome: COVID-19 burden of diseases (BOD)
Time frame: within 48 weeks following randomisation (day of vaccination)
COVID-19 burden of diseases (BOD), a composite, will be scored as by using 0 for no COVID-19, 1 for non-severe COVID-19, and 2 for severe COVID-19.
Duration of RCT set up (specific endpoint related to trial conduct feasibility)
Time frame: one time assessment at baseline (from deciding which interventions will be tested until the first patient is randomised)
Duration of RCT set up (i.e. time from deciding which interventions will be tested until the first patient is randomised).
Time of patient recruitment from activation of first study site until 40 patients are randomised
Time frame: one time assessment after approx. 3 months (from activation of first study site until 40 patients are randomised)
Time of patient recruitment from activation of first study site until 40 patients are randomised
Time of patient recruitment from activation of first study site until 380 patients are randomised
Time frame: one time assessment after approx. 3 months (from activation of first study site until 380 patients are randomised)
Time of patient recruitment from activation of first study site until 380 patients are randomised
Patient consent rate
Time frame: approx. 3 months
Patient consent rate (i.e. proportion of patients giving informed consent out of approached eligible patients)
Proportion of missing data for all baseline variables from routinely collected cohort data
Time frame: one time assessment at baseline
Proportion of missing data for all baseline variables from routinely collected cohort data
Proportion of missing data for all clinical outcomes
Time frame: one time assessment after approx. 3 months
Proportion of missing data for all clinical outcomes from routinely collected cohort data and outcome data that is collected in the trial platform
SARS-CoV-2-specific antibodies
Time frame: three months after vaccination
SARS-CoV-2-specific antibodies (using a pan-IgG antibody assay against the receptor binding domain (RBD) against the nP and spike 1 subunits)
SARS-CoV-2-specific titers
Time frame: three months after vaccination
SARS-CoV-2-specific titers (using an in-house assay developed by the Institute of Medical Virology, University of Zurich which can detect multiple viral epitopes)
The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed in the observational second sub- protocol
Time frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination
The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed or plasma assessed in the observational second sub- protocol by the commercial immunoassay Elecsys Anti-SARS-CoV-2 S (Elecsys S) from Roche Diagnostics. An antibody response will be considered as positive using the threshold ≥ 100 units/ml, predicting a protective immune response.
6 secondary outcomes
The proportion of patients with a positive antibody response using SARS-CoV-2 spike (S1) Elecsys S by Roche in the observational second sub- protocol, using a threshold of ≥0.8 units/ml as defined by the manufacturer
Time frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination
The proportion of patients with a positive antibody response using antibody response using the Antibody CORonavirus Assay (ABCORA) 2 in the observational second sub- protocol
Time frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination
The proportion of patients with neutralizing neutralization activity against the vaccine strain Wuhan-Hu-1 in the observational second sub- protocol
Time frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Immune response (pan-Ig antibodies against the receptor binding domain (RBD) in the S1 subunit of the spike protein (pan-Ig anti-S1-RBD) of SARS-CoV-2 in the observational second sub- protocol
Time frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Mean immune response of IgM, IgA and IgG to the subunit S1 using ABCORA in the observational second sub- protocol
Time frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Number of newly PCR-confirmed asymptomatic SARS-CoV-2 infection in the observational second sub- protocol
Time frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Results publication: PubMed 35234868Speich B, Chammartin F, Abela IA, Amico P, Stoeckle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Audige A, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Trkola A, Briel M, Kusejko K, Bucher HC; Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Antibody Response in Immunocompromised Patients After the Administration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine BNT162b2 or mRNA-1273: A Randomized Controlled Trial. Clin Infect Dis. 2022 Aug 24;75(1):e585-e593. doi: 10.1093/cid/ciac169.
- Results publication: PubMed 35902817Kusejko K, Chammartin F, Smith D, Odermatt M, Schuhmacher J, Koller M, Gunthard HF, Briel M, Bucher HC, Speich B; Swiss HIV Cohort Study; Swiss Transplant Cohort Study. Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients. BMC Infect Dis. 2022 Jul 28;22(1):654. doi: 10.1186/s12879-022-07621-x.
- Derived from this study: PubMed 38848312Amstutz A, Chammartin F, Audige A, Eichenberger AL, Braun DL, Amico P, Stoeckle MP, Hasse B, Papadimitriou-Olivgeris M, Manuel O, Bongard C, Schuurmans MM, Hage R, Damm D, Tamm M, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Schonenberger CM, Griessbach A, Labhardt ND, Kouyos RD, Trkola A, Kusejko K, Bucher HC, Abela IA, Briel M, Speich B; Swiss HIV Cohort Study; Swiss Transplant Cohort. Antibody and T-Cell Response to Bivalent Booster SARS-CoV-2 Vaccines in People With Compromised Immune Function: COVERALL-3 Study. J Infect Dis. 2024 Oct 16;230(4):e847-e859. doi: 10.1093/infdis/jiae291.
- Derived from this study: PubMed 38023564Griessbach A, Chammartin F, Abela IA, Amico P, Stoeckle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Audige A, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Trkola A, Epp S, Amstutz A, Schonenberger CM, Taji Heravi A, Papadimitriou-Olivgeris M, Casutt A, Manuel O, Kusejko K, Bucher HC, Briel M, Speich B; Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Antibody Response After the Third SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients and People Living With HIV (COVERALL-2). Open Forum Infect Dis. 2023 Nov 3;10(11):ofad536. doi: 10.1093/ofid/ofad536. eCollection 2023 Nov.
- Derived from this study: PubMed 37830908Chammartin F, Griessbach A, Kusejko K, Audige A, Epp S, Stoeckle MP, Eichenberger AL, Amstutz A, Schoenenberger CM, Hasse B, Braun DL, Rauch A, Trkola A, Briel M, Bucher HC, Gunthard HF, Speich B, Abela IA; Swiss HIV Cohort Study. Bridging the gap: identifying factors impacting mRNA severe acute respiratory syndrome coronavirus 2 vaccine booster response in people with HIV-1. AIDS. 2024 Feb 1;38(2):217-222. doi: 10.1097/QAD.0000000000003751. Epub 2023 Oct 11.
- Derived from this study: PubMed 35876706Chammartin F, Kusejko K, Pasin C, Trkola A, Briel M, Amico P, Stoekle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Mueller NJ, Rauch A, Koller MT, Gunthard HF, Bucher HC, Speich B, Abela IA; and the Swiss HIV Cohort Study. Determinants of antibody response to severe acute respiratory syndrome coronavirus 2 mRNA vaccines in people with HIV. AIDS. 2022 Aug 1;36(10):1465-1468. doi: 10.1097/QAD.0000000000003246. Epub 2022 Jul 9.
- Derived from this study: PubMed 34674742Speich B, Chammartin F, Smith D, Stoeckle MP, Amico P, Eichenberger AL, Hasse B, Schuurmans MM, Muller T, Tamm M, Dickenmann M, Abela IA, Trkola A, Hirsch HH, Manuel O, Cavassini M, Hemkens LG, Briel M, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Bucher HC, Kusejko K; study groups from the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty(R) and COVID-19 mRNA Vaccine Moderna(R). Trials. 2021 Oct 21;22(1):724. doi: 10.1186/s13063-021-05664-0.
Related trials for Immunocompromised Patients
RecruitingPhase 2
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Locally Recurrent Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
RecruitingObservational study
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Critically-ill Patients
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.
Heiner C. Bucher, Prof. Dr. med. principal investigator
Basel Institute for Clinical Epidemiology & Biostatistics, University Hospital Basel
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) and Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®) in people with Immunocompromised Patients, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
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 8 inclusion and 14 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: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
immunological outcome: change in pan-Ig antibody response (pan-Ig anti-S1-RBD) (time frame: at baseline (day of vaccination) and three months after vaccination). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805125, which also lists 7 linked publications.
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 25 Jan 2024.