Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT05599802
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2022-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-30', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'GMT of SARS-CoV-2 VNA (live virus assay).', 'timeFrame': '3 months and 6 months after (full) vaccination'}, {'measure': 'SCR of SARS-CoV-2 VNA (live virus assay).', 'timeFrame': '3 months and 6 months after (full) vaccination'}, {'measure': 'GMI of SARS-CoV-2 VNA (live virus assay).', 'timeFrame': '3 months and 6 months after (full) vaccination'}, {'measure': 'GMT of S-protein specific IgG antibodies (ELISA)', 'timeFrame': '3 months and 6 months after (full) vaccination'}, {'measure': 'SCR of S-protein specific IgG antibodies (ELISA)', 'timeFrame': '3 months and 6 months after (full) vaccination'}, {'measure': 'GMI of S-protein specific IgG antibodies (ELISA)', 'timeFrame': '3 months and 6 months after (full) vaccination'}], 'primaryOutcomes': [{'measure': 'Incidence, severity, and duration of each solicited (local and systemic) AE.', 'timeFrame': 'Within 30 minutes and 7 days after (each dose of) vaccination'}, {'measure': 'Incidence, severity, and duration of each unsolicited AE.', 'timeFrame': 'Within 28 days after (each dose of) vaccination'}, {'measure': 'The percentage of participants with abnormal hematology and chemistry laboratory values.', 'timeFrame': '4 days after (each dose of) vaccination'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).', 'timeFrame': 'Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination'}, {'measure': 'Seroconversion Rate (SCR) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).', 'timeFrame': 'Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination'}, {'measure': 'Geometric Mean Increase (GMI) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).', 'timeFrame': 'Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination'}, {'measure': 'GMT of S-protein specific IgG antibodies (ELISA)', 'timeFrame': 'Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination'}, {'measure': 'SCR of S-protein specific IgG antibodies (ELISA)', 'timeFrame': 'Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination'}, {'measure': 'GMI of S-protein specific IgG antibodies (ELISA)', 'timeFrame': 'Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination'}, {'measure': 'The incidence, severity, and causality of Serious Adverse Events (SAEs)', 'timeFrame': 'Within 12 months after (full) vaccination'}, {'measure': 'The incidence, severity, and causality of Adverse Events of Special Interest (AESI)', 'timeFrame': 'Within 12 months after (full) vaccination'}, {'measure': 'The incidence, severity, and causality of the occurrence of pregnancy events', 'timeFrame': 'Within 12 months after (full) vaccination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2']}, 'descriptionModule': {'briefSummary': 'An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed).\n* Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.\n* Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners prior to the (1st dose of) vaccination and must agree to continue such precautions during the study until 3 months after (full) vaccination.\\[Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices(IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.\\].\n* For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before (each dose of) vaccination in this study.\n* On the day of vaccination and 24 hours prior to (each dose of) vaccination, axillary temperatures\\<37.3℃/99.1°F.\n* Healthy participants or participants with mild underlying disease \\[in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study\\].\n* (For group 2 and group 3 only) Participants who have received full primary vaccination of licensed SARS-CoV-2 vaccine (3-8 weeks between 2 doses of COVID-19 inactivated vaccine or 2 doses of COVID-19 mRNA vaccine) and whose last dose was given \\>6 mony\n* (For group 1 only) Not have received any COVID-19 vaccine prior to enrollment.\n\nExclusion Criteria:\n\n* Any screening hematology and/or blood biochemistry laboratory value that meets the definition of a ≥Grade 1 abnormality,\n* (For group 1 only) Confirmed SARS-CoV-2 diagnosis within 1 years before screening visit.\n* History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections.\n* Receipt of medications intended to treat COVID-19 with 1 year.\n* History of server adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).\n* SARS-CoV-2 RT-PCR positive nasopharyngeal/oropharyngeal swab specimens at screening.\n* Positive HIV test at screening.\n* A history or family history of convulsions, epilepsy, encephalopathy and psychosis.\n* Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period.\n* Asplenia of functional asplenia, complete or partial splenectomy from any cause.\n* Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids are permitted.\n* Any other licensed vaccines given within 28 days prior to the investigational vaccination, or planned administration of vaccine(s) within 28 days after (full) vaccination.\n* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, form 60 days before vaccine administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before vaccine administration, or planned receipt throughout the study.\n* Blood donation or blood loss ≥450ml within 1 month prior to enrollment or planned to donate blood during the study period.\n* Participation in other studies involving study intervention within 28 days prior to study entry, and/or during the study.\n* Women who are pregnant or breastfeeding.\n* Participants deemed unsuitable for participation in this study based on the investigator's assessment.\n* (For group 1 only: Criteria for delay of 2nd dose of vaccination) Fever within 24 hours prior to the 2nd dose of vaccination (axillary body temperature ≥37.3℃/99.1°F).\n* (For group 1 only: Criteria for delay of 2nd dose of vaccination) During treatment/recovery from illness.\n* (For group 1 only: Criteria for delay of 2nd dose of vaccination) Other conditions considered by the investigator to be unsuitable for vaccination.\n* (For group 1 only: Criteria for termination of 2nd dose of vaccination) Participants with a positive urine pregnancy or blood pregnancy test (women of childbearing age only).\n* (For group 1 only: Criteria for termination of 2nd dose of vaccination) Serious allergic reactions or serious adverse events related to vaccination (as assessed by the investigator) following a previous dose of vaccine.\n* (For group 1 only: Criteria for termination of 2nd dose of vaccination) Positive result for SARS-CoV-2 (positive RT-PCR test).\n* (For group 1 only: Criteria for termination of 2nd dose of vaccination) The investigator considers inappropriate for the participants to continue participation in the study."}, 'identificationModule': {'nctId': 'NCT05599802', 'briefTitle': 'Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AIM Vaccine Co., Ltd.'}, 'officialTitle': 'An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) in Healthy Participants Aged 18 Years and Older', 'orgStudyIdInfo': {'id': 'LVRNA010-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1A: 50μg SARS-CoV-2 variant mRNA vaccine', 'description': 'Participants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.', 'interventionNames': ['Biological: SARS-CoV-2 variant mRNA vaccine low dose']}, {'type': 'EXPERIMENTAL', 'label': '1B: 100μg SARS-CoV-2 variant mRNA vaccine', 'description': 'Participants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.', 'interventionNames': ['Biological: SARS-CoV-2 variant mRNA vaccine high dose']}, {'type': 'EXPERIMENTAL', 'label': '2A: 50μg SARS-CoV-2 variant mRNA vaccine', 'description': 'Participants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.', 'interventionNames': ['Biological: SARS-CoV-2 variant mRNA vaccine low dose']}, {'type': 'EXPERIMENTAL', 'label': '2B: 100μg SARS-CoV-2 variant mRNA vaccine', 'description': 'Participants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.', 'interventionNames': ['Biological: SARS-CoV-2 variant mRNA vaccine high dose']}, {'type': 'EXPERIMENTAL', 'label': '3A: 50μg SARS-CoV-2 variant mRNA vaccine', 'description': 'Participants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.', 'interventionNames': ['Biological: SARS-CoV-2 variant mRNA vaccine low dose']}, {'type': 'EXPERIMENTAL', 'label': '3B: 100μg SARS-CoV-2 variant mRNA vaccine', 'description': 'Participants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.', 'interventionNames': ['Biological: SARS-CoV-2 variant mRNA vaccine high dose']}], 'interventions': [{'name': 'SARS-CoV-2 variant mRNA vaccine low dose', 'type': 'BIOLOGICAL', 'description': '50μg/dose', 'armGroupLabels': ['1A: 50μg SARS-CoV-2 variant mRNA vaccine', '2A: 50μg SARS-CoV-2 variant mRNA vaccine', '3A: 50μg SARS-CoV-2 variant mRNA vaccine']}, {'name': 'SARS-CoV-2 variant mRNA vaccine high dose', 'type': 'BIOLOGICAL', 'description': '100μg/dose', 'armGroupLabels': ['1B: 100μg SARS-CoV-2 variant mRNA vaccine', '2B: 100μg SARS-CoV-2 variant mRNA vaccine', '3B: 100μg SARS-CoV-2 variant mRNA vaccine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Prof. Dr. M. Raza Shah', 'role': 'CONTACT', 'email': 'razashahm@yahoo.com', 'phone': '（92-21）37715064'}], 'overallOfficials': [{'name': 'Prof. Dr. M. Raza Shah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Bioequivalence Studies and Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AIM Vaccine Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ningbo Rongan Biological Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'LiveRNA Therapeutics Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}