Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 6:32 AM
Study NCT ID:
NCT05124561
Status:
WITHDRAWN
Last Update Posted:
2023-06-18
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the inHaled Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) On the Protective-Efficacy in Adults (SeiHOPE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'C566578', 'term': 'Alzheimer Disease 5'}], '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': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The trial protocol was not approved by the regulatory authorities.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of COVID-19 cases.', 'timeFrame': 'Day 14 to 12 months post vaccination', 'description': 'The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.'}, {'measure': 'Incidence of SAE', 'timeFrame': 'Within 12 months post vaccination', 'description': 'Evaluate the incidence of severe adverse events (SAE)'}], 'secondaryOutcomes': [{'measure': 'Incidence of COVID-19 cases', 'timeFrame': 'Day 28 to 12 months post vaccination', 'description': 'The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.'}, {'measure': 'Incidence of severe COVID-19 cases', 'timeFrame': 'Day 14 and Day 28 to 12 months post vaccination', 'description': 'Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection.'}, {'measure': 'Incidence of COVID-19 cases in different age groups', 'timeFrame': 'Day 14 and Day 28 to 12 months post vaccination', 'description': 'The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease in participants between 18-59 years, and participants aged 60 years and above.'}, {'measure': 'Incidence of Adverse Reactions (ARs)', 'timeFrame': 'Within 30 minutes post vaccination', 'description': 'Incidence of ARs within 30 minutes post vaccination in the safety cohort.'}, {'measure': 'Incidence of Adverse Reactions (ARs)', 'timeFrame': 'Within 14 days post vaccination', 'description': 'Incidence of ARs within 14 days post vaccination in the safety cohort.'}, {'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Within 28 days post vaccination', 'description': 'Incidence of AEs within 28 days post vaccination in the safety cohort.'}, {'measure': 'Immunogenicity of S-RBD IgG antibody (ELISA method)', 'timeFrame': 'Day 14, Day 28, Week 24, and Week 52 post-vaccination', 'description': 'Seroconversion rate of S-RBD IgG antibody post vaccination.'}, {'measure': 'Immunogenicity of S-RBD IgG antibody (ELISA method)', 'timeFrame': 'Day 14, Day 28, Week 24, and Week 52 post-vaccination', 'description': 'GMT of S-RBD IgG antibody post vaccination.'}, {'measure': 'Immunogenicity of S-RBD IgG antibody (ELISA method)', 'timeFrame': 'Day 14, Day 28, Week 24, and Week 52 post-vaccination', 'description': 'GMI of S-RBD IgG antibody post vaccination.'}, {'measure': 'Immunogenicity of neutralizing antibodies', 'timeFrame': 'Day 14, Day 28, Week 24, and Week 52 post-vaccination', 'description': 'Seroconversion rate of neutralizing antibodies post vaccination.'}, {'measure': 'Immunogenicity of neutralizing antibodies', 'timeFrame': 'Day 14, Day 28, Week 24, and Week 52 post-vaccination', 'description': 'GMT of neutralizing antibodies post vaccination.'}, {'measure': 'Immunogenicity of neutralizing antibodies', 'timeFrame': 'Day 14, Day 28, Week 24, and Week 52 post-vaccination', 'description': 'GMI of neutralizing antibodies post vaccination.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Vaccine', 'Inhalation', 'Ad5', 'Efficacy', 'Safety', 'Immunogenicity'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV \\> 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult volunteers aged 18 years and above who have received 1 dose of intramuscular Ad5-nCoV \\> 56 days at the enrollment.\n* Volunteers who have provided informed consent and signed the informed consent form.\n* Volunteers who are able and willing to comply with the requirements of the clinical study protocol, and can complete the entire follow-up period of this study.\n\nExclusion Criteria:\n\n* Allergic to the active ingredient, any non-active ingredient, or substances used in the manufacturing process, or developed an allergy to similar vaccines in the past.\n* History of severe anaphylactic reaction to vaccines (e.g., acute anaphylactic reactions, angioedema, dyspnea).\n* History or family history of seizures, epilepsy, encephalopathy, or psychosis.\n* Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, throat redness, and swelling.\n* History of a definite diagnosis of COVID-19.\n* Positive SARS-CoV-2 N antibody rapid screening kit (IgG and IgM) results.\n* Received COVID-19 vaccine other than Ad5-nCoV.\n* Axillary temperature \\> 37.0°C.\n* Severe cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, or severe hypertension and cannot be controlled by drugs.\n* Lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis.\n* Acute febrile illness, symptoms of upper respiratory tract infection, or infectious diseases.\n* Severe chronic diseases, or diseases of the progressive stage that cannot be steadily controlled, such as diabetes or thyroid disorders.\n* Asplenia or functional asplenia.\n* Thrombocytopenia or other coagulation disorder.\n* Received immunosuppressant or immunomodulatory therapy (continuous oral or intravenous infusion for more than 14 days), anti-allergic therapy, cytotoxic therapy within the past 6 months. Inhalational and local steroids are allowed.\n* Received blood products within 4 months before receiving the investigational vaccine.\n* Received other vaccines within the past 14 days or plan to receive other vaccines 14 days after scheduled immunization with the investigational vaccine.\n* Volunteers under antituberculous treatment or with active tuberculosis.\n* Received blood/plasma products or immunoglobulin 60 days before immunization with the investigational vaccine or planned to receive blood/plasma products or immunoglobulin during the entire study period.\n* Females who are positive for the urine pregnancy test, pregnant, or breastfeeding, or females who plan to conceive within 3 months (urine pregnancy test will only be performed in female volunteers of childbearing age).\n* Volunteers who are judged by the investigator with any contradiction to the study protocol or affected the signing of informed consent due to various medical, psychological,social, or other conditions.'}, 'identificationModule': {'nctId': 'NCT05124561', 'briefTitle': 'Study to Evaluate the inHaled Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) On the Protective-Efficacy in Adults (SeiHOPE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CanSino Biologics Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV', 'orgStudyIdInfo': {'id': 'CS-CTP-AD5NCOV-IH-Ⅲ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '6500 participants, Ad5-nCoV-IH, single dose, nebulized inhalation', 'interventionNames': ['Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '6500 participants, placebo, single dose, nebulized inhalation', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)', 'type': 'BIOLOGICAL', 'description': 'Nebulized inhalation through the mouth', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Nebulized inhalation through the mouth', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fengcai Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CanSino Biologics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Institute of Biotechnology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}