Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2
Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Biological samples
What it measured
Main measures
Protective humoral response after vaccination
Month 2
Other measures (15)
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 0
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 1
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 2
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 3
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 6
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 0
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 1
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 2
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 3
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Month 6
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups: * Group of immunocompromised (15 participants per immunosuppression subgroup): * Kidney transplant * Extracorporeal dialysis * Solid cancer under chemotherapy and / or radiotherapy * Myeloma under chemotherapy * Hematologic malignancies under chemotherapy * Diseases treated with anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after) * Multiple sclerosis under anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after) * Common variable immune deficiency or other causes of severe hypogammaglobulinemia requiring chronic treatment with polyvalent immunoglobulin * Malignant tumor under anti-PD1 or anti-PDL1 * People living with HIV * Complicated type 2 diabetes (with micro and / or macroangiopathy) * Group of non-immunocompromised subjects (controls, n = 75) * 60 people vaccinated with the ComirnatyTM * 15 people vaccinated with Astra Zeneca's VaxzevriaTM for the first dose
Exclusion criteria
* Minors * Pregnant or breastfeeding women * Persons under tutorship or curatorship * Protected adults * Person under legal protection * Person not affiliated to a social security scheme * People with a contraindication to receiving the ComirnatyTM vaccine * People who have already been vaccinated against SARS-CoV-2 Note: a history of COVID-19 (> at 3 months) is not a contraindication to vaccination and is therefore not a criterion for non-inclusion in the study.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.
Papers
Background
Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C,Background
Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of
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History
Started
Mar 2021
Main results due
Feb 2022
Finished
Feb 2022