Covid19HEMVACONCT04852796
Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients
An observational study of Covid19 and Hematologic Malignancy, run by Centre Hospitalier de Cornouaille at 1 site in France.
Trial summary
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in December 2019 in Wuhan, China. Infection with this new coronavirus called SARS-CoV-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Hematologic Malignancy, Vaccine Response Impaired
- What is being tested?
- Patients with hemopathy
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 1 Apr 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Patients with hemopathy followed in declared hospitals
Who may be able to join
- Benign or malignant hemopathy
- With priority vaccination indication
- Having benefited from anti-covid-19 mRNA vaccination
Who cannot join
- Patients under legal protection
- Palliative care patients
- History of known Covid-19 disease (<1 year)
Trial locations and contacts
1 site in 1 country.
About this study
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in December 2019 in Wuhan, China. Infection with this new coronavirus called SARS-CoV-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (ICU).
Hospitalized patients with hematologic malignancies have a higher mortality rate than patients without hematologic malignancies (62% vs. 8%). The severity of Covid-19 may be related to their treatment, in particular anti-CD20 used in B lymphoid hemopathies. In fact, anti-CD20 antibodies induce rapid and prolonged depletion of B cells, but they are necessary for development. humoral immune responses.
But currently, no immunogenicity data are known for patients with hemopathy or in those on anti-lymphocyte immunochemotherapy.
Read the detailed description
The aim of this study is to evaluate the humoral response after vaccination against SARS-CoV-2 in a French multicenter cohort of patients with hemopathies. Analysis of hemopathies and immunochemotherapy subgroups will determine whether there is a need to strengthen immunization schedules. In addition, the study wish to assess the safety and clinical efficacy of mRNA vaccines in this cohort.
- Conditions
- Covid19, Hematologic Malignancy, Vaccine Response Impaired
- Being tested
- Patients with hemopathy
- Medical subject headings
- COVID-19, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with hemopathyOther
optimal humoral response at 1 month after COVID-19 vaccination
What is being measured
The primary outcome is the main question the study is designed to answer.
humoral response after COVID19 vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
Measured: 1 month after vaccination
Secondary outcomes (7)
humoral response after COVID19 vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
Measured: before first dose vaccination
humoral response after COVID19 vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
Measured: before second dose vaccination
humoral response after COVID19 vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
Measured: 3 months after vaccination
humoral response after COVID19 vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
Measured: 6 months after vaccination
humoral response after COVID19 vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
Measured: 12 months after vaccination
clinical response after COVID19 vaccination
SARS-CoV-2 disease onset in the follow-up
Measured: 12 months after vaccination
security of mRNA COVID19 vaccine
side effects onset in the follow-up
Measured: 3 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cornouaille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LENAIG LE CLECH, PhD, Principal investigator, Centre Hospitalier de Quimper Cornouaille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852796
- Sponsor's protocol ID
- QP2021-PPD
- Acronym
- HEMVACO
- Status last verified
- Aug 2023
- First submitted
- 30 Mar 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gueguen M, Khatchatourian L, Loheac C, Dorval I, Mercier M, Le Calloch R, Mahe K, Rizcallah MJ, Hutin P, Fangous MS, Saidani N, Le Clech L. The humoral response of mRNA COVID-19 vaccine in hematological diseases: The HEMVACO study. Infect Dis Now. 2022 Aug;52(5):280-285. doi: 10.1016/j.idnow.2022.05.008. Epub 2022 Jun 3.
PubMed 35667558
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients
- ClinicalTrials.gov ID
- NCT04852796
- Acronym / sponsor ID
- HEMVACO / QP2021-PPD
- Conditions
- Covid19, Hematologic Malignancy, Vaccine Response Impaired
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre Hospitalier de CornouailleUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Apr 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.
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in December 2019 in Wuhan, China. Infection with this new coronavirus called SARS-CoV-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (ICU).
Hospitalized patients with hematologic malignancies have a higher mortality rate than patients without hematologic malignancies (62% vs. 8%). The severity of Covid-19 may be related to their treatment, in particular anti-CD20 used in B lymphoid hemopathies. In fact, anti-CD20 antibodies induce rapid and prolonged depletion of B cells, but they are necessary for development. humoral immune responses.
But currently, no immunogenicity data are known for patients with hemopathy or in those on anti-lymphocyte immunochemotherapy.
Detailed description
The aim of this study is to evaluate the humoral response after vaccination against SARS-CoV-2 in a French multicenter cohort of patients with hemopathies. Analysis of hemopathies and immunochemotherapy subgroups will determine whether there is a need to strengthen immunization schedules. In addition, the study wish to assess the safety and clinical efficacy of mRNA vaccines in this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hemopathy followed in declared hospitals
Key inclusion criteria (3 listed)
- Benign or malignant hemopathy
- With priority vaccination indication
- Having benefited from anti-covid-19 mRNA vaccination
Key exclusion criteria (3 listed)
- Patients under legal protection
- Palliative care patients
- History of known Covid-19 disease (<1 year)
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 |
|---|---|---|
| Patients with hemopathyoptimal humoral response at 1 month after COVID-19 vaccination | Other | – |
Primary outcome
humoral response after COVID19 vaccination
Time frame: 1 month after vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
7 secondary outcomes
humoral response after COVID19 vaccination
Time frame: before first dose vaccination
humoral response after COVID19 vaccination
Time frame: before second dose vaccination
humoral response after COVID19 vaccination
Time frame: 3 months after vaccination
humoral response after COVID19 vaccination
Time frame: 6 months after vaccination
humoral response after COVID19 vaccination
Time frame: 12 months after vaccination
clinical response after COVID19 vaccination
Time frame: 12 months after vaccination
security of mRNA COVID19 vaccine
Time frame: 3 months after 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 30 Aug 2023.
- Derived from this study: PubMed 35667558Gueguen M, Khatchatourian L, Loheac C, Dorval I, Mercier M, Le Calloch R, Mahe K, Rizcallah MJ, Hutin P, Fangous MS, Saidani N, Le Clech L. The humoral response of mRNA COVID-19 vaccine in hematological diseases: The HEMVACO study. Infect Dis Now. 2022 Aug;52(5):280-285. doi: 10.1016/j.idnow.2022.05.008. Epub 2022 Jun 3.
Related trials for Covid19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
LENAIG LE CLECH, PhD principal investigator
Centre Hospitalier de Quimper Cornouaille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Hematologic Malignancy, run by Centre Hospitalier de Cornouaille at 1 site in France.
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 3 inclusion and 3 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 30 Aug 2023. 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 France. 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?
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?
humoral response after COVID19 vaccination (time frame: 1 month after vaccination). 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 NCT04852796, which also lists 1 linked publication.
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 30 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.