A Global Multi-center Clinical Study of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19
NCT ID: NCT05682638
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
34000 participants
INTERVENTIONAL
2023-01-30
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population Aged 18 Years and Above
NCT04847102
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine
NCT05636319
Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
NCT04982068
Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older
NCT05683600
GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)
NCT04673149
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vaccine group
Phase 3(Base the result of Phase 1 and Phase 2, intervent 100μg): initial vaccination stage- LVRNA009; crossover vaccination stage- placebo
LVRNA009
100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart
0.9%NaCl
1.0ml/dose, 2 injection with 28 days apart
Control group
Phase 3: initial vaccination stage- placebo; crossover vaccination stage- LVRNA009
LVRNA009
100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart
0.9%NaCl
1.0ml/dose, 2 injection with 28 days apart
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LVRNA009
100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart
0.9%NaCl
1.0ml/dose, 2 injection with 28 days apart
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Understand the content of the Informed Consent Form (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).
3. Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
4. Female participants of childbearing potential or partners of male participants:
voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after full vaccination (including the initial set of vaccination and crossover set of vaccination). \[Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.\].
5. 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 vaccination in this study.
6. On the day of 1st dose of vaccination and 24 hours prior to vaccination, axillary temperatures \<37.3°C/99.1°F.
7. Healthy participants or participants with mild underlying disease \[in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study\].
Exclusion Criteria
2. Individuals using prescription medications for prophylaxis or treatment of SARS-CoV-2 (including vaccination of licensed COVID-19 vaccines).
3. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
4. History of allergy to any component of the study vaccine or history of severe allergic reaction to vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
5. Positive nucleic acid for SARS-CoV-2 in nasopharyngeal/oropharyngeal swab specimens.
6. Positive HIV test results.
7. A history or family history of convulsions, epilepsy, encephalopathy and psychosis.
8. Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period.
9. Asplenia or functional asplenia, complete or partial splenectomy from any cause.
10. Prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, ≥20 mg/d prednisone or equivalent; however, inhaled and topical steroids are permitted) within 6 months prior to the 1st dose of investigational vaccine.
11. Any other licensed vaccines given within 28 days prior to the study vaccination, or planned administration of vaccine(s) within 28 days after the 2nd dose in the blinded crossover vaccination.
12. Have received immunoglobulin or other blood products within 3 months prior to enrollment or plan to receive them during the study period.
13. Blood donation or blood loss ≥ 450 mL within 1 month prior to enrollment or planned to donate blood during the study period.
14. Participants who have received any other investigational product within 1 month prior to enrollment or intent to participate in another clinical study at any time during the conduct of this study.
15. Women who are pregnant or breastfeeding.
16. Participants deemed unsuitable for participation in this study based on the investigator's assessment.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AIM Innovation Biotechnology (Shanghai) Co., Ltd
UNKNOWN
Ningbo Rongan Biological Pharmaceutical Co., Ltd.
INDUSTRY
LiveRNA Therapeutics Inc.
UNKNOWN
AIM Vaccine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KEMRI CRDR Research Annex, Siaya Country Referral Hospital
Siaya, , Kenya
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LVRNA009-II/III-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.