Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT04852835
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2021-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient', 'timeFrame': 'up to 1 month post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'Vaccine', 'Humoral response', 'Anti-spike antibodies', 'Neutralizing antibodies', 'Gender'], 'conditions': ['COVID-19 Vaccines']}, 'descriptionModule': {'briefSummary': 'Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any person, male or female, over 18 years of age who underwent vaccination and anti-SARS-CoV-2 serological test after vaccination', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Any person, male or female, over 18 years of age who underwent vaccination and\n\n* anti-SARS-CoV-2 serological test after vaccination\n* having already given their consent for their biological resources to be:\n\n * stored in a biocollection of the Microbiology Technical Platform (PTM) having received an approval from the CPP Est-IV and declared to the Ministry of Education and Research under reference No. DC2009-1002;\n * subsequently reused, as well as the anonymized associated data, for research purposes\n\nExclusion Criteria:\n\n* Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)\n* Person under safeguard of justice\n* Person under guardianship or curatorship-'}, 'identificationModule': {'nctId': 'NCT04852835', 'acronym': 'COVACHUS', 'briefTitle': 'Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals', 'orgStudyIdInfo': {'id': '8223'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Samira FAFI-KREMER, PharmD, PhD', 'role': 'CONTACT', 'email': 'Samira.fafi-kremer@chru-strasbourg.fr', 'phone': '33.3.69.55.14.38'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}, {'name': 'Samira FAFI-KREMER, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie-Josée Wendling, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aurélie Velay, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Floriane Gallais, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre Gantner, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Morgane Solis, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elodie Laugel, PH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Virologie - Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Samira FAFI-KREMER, PharmD, PhD', 'role': 'CONTACT', 'email': 'Samira.fafi-kremer@chru-strasbourg.fr', 'phone': '33.3.69.55.14.38'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}], 'overallOfficials': [{'name': 'Samira FAFI-KREMER, PharmD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Service de Virologie - Hôpital Civil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}