- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05682638
A Global Multi-center Clinical Study of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19
A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Videlis Nduba, PHD
- Phone Number: 254-724-52247
- Email: vnduba@gmail.com
Study Locations
-
-
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Siaya, Kenya, 144-40600
- Recruiting
- KEMRI CRDR Research Annex, Siaya Country Referral Hospital
-
Contact:
- Videlis Nduba, PHD
- Phone Number: 254-724-52247
- Email: vnduba@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 18 years and older.
- 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).
- Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
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.].
- 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.
- On the day of 1st dose of vaccination and 24 hours prior to vaccination, axillary temperatures <37.3°C/99.1°F.
- 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:
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections.
- Individuals using prescription medications for prophylaxis or treatment of SARS-CoV-2 (including vaccination of licensed COVID-19 vaccines).
- History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
- 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)).
- Positive nucleic acid for SARS-CoV-2 in nasopharyngeal/oropharyngeal swab specimens.
- Positive HIV test results.
- A history or family history of convulsions, epilepsy, encephalopathy and psychosis.
- Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period.
- Asplenia or functional asplenia, complete or partial splenectomy from any cause.
- 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.
- 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.
- Have received immunoglobulin or other blood products within 3 months prior to enrollment or plan to receive them during the study period.
- Blood donation or blood loss ≥ 450 mL within 1 month prior to enrollment or planned to donate blood during the study period.
- 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.
- Women who are pregnant or breastfeeding.
- Participants deemed unsuitable for participation in this study based on the investigator's assessment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vaccine group
Phase 3(Base the result of Phase 1 and Phase 2, intervent 100μg): initial vaccination stage- LVRNA009; crossover vaccination stage- placebo
|
100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart
1.0ml/dose, 2 injection with 28 days apart
|
Placebo Comparator: Control group
Phase 3: initial vaccination stage- placebo; crossover vaccination stage- LVRNA009
|
100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart
1.0ml/dose, 2 injection with 28 days apart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring in SARS-CoV-2 naive participants in vaccine(100μg) group
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 for SARS-CoV-2 naive participants
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 naive participants
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death for SARS-CoV-2 naive participants
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 naive participants at different age strata (18-59 years, ≥60 years)
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 non-naive participants
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 non-naive participants
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring regardless prior SARS-CoV-2 infection
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring
Time Frame: From the 1st dose in the initial set of vaccination
|
From the 1st dose in the initial set of vaccination
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The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring
Time Frame: From 7 days after the 2nd dose in the initial set of vaccination
|
From 7 days after the 2nd dose in the initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 for SARS-CoV-2 native participants
Time Frame: From 14 days after the 2nd dose in the crossover set of vaccination
|
From 14 days after the 2nd dose in the crossover set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 naive participants
Time Frame: From 14 days after the 2nd dose in the crossover set of vaccination
|
From 14 days after the 2nd dose in the crossover set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death regardless prior SARS-CoV-2 infection
Time Frame: From 14 days after the 2nd dose in the crossover set of vaccination
|
From 14 days after the 2nd dose in the crossover set of vaccination
|
Incidence, severity and duration of each solicited (local and systemic) Adverse Event (AE)
Time Frame: Within 14 days post each dose in reactogenicity subgroup in the initial set of vaccination
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Within 14 days post each dose in reactogenicity subgroup in the initial set of vaccination
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Incidence, severity, and causality of AEs occurring
Time Frame: 0-28 days post each dose
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0-28 days post each dose
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Incidence, severity, and causality of Serious Adverse Events (SAEs)
Time Frame: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
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From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
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Incidence, severity, and causality of Adverse Events of Special Interest (AESIs)
Time Frame: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
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From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
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Incidence, severity, and causality of pregnancy events
Time Frame: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
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From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
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Geometric mean Titer (GMT) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time Frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
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14 days, 28 days, 3 months and 6 months after the 2nd dose
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Geometric mean Titer (GMT) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses in the crossover set of vaccination
Time Frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
|
28 days, 3 months, 6 months and 12 months after the 2nd dose
|
Geometric mean Increase (GMI) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time Frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
|
14 days, 28 days, 3 months and 6 months after the 2nd dose
|
Geometric mean Increase (GMI) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses in the crossover set of vaccination
Time Frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
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28 days, 3 months, 6 months and 12 months after the 2nd dose
|
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seronegative participants at baseline of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time Frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
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14 days, 28 days, 3 months and 6 months after the 2nd dose
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The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seronegative participants at baseline in the crossover set of vaccination
Time Frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
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28 days, 3 months, 6 months and 12 months after the 2nd dose
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The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seropositive participants at baseline of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time Frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
|
14 days, 28 days, 3 months and 6 months after the 2nd dose
|
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seropositive participants at baseline in the crossover set of vaccination
Time Frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
|
28 days, 3 months, 6 months and 12 months after the 2nd dose
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cellular immune subgroup: The specific cellular immune response (IL-2) to SARS-CoV-2 (ELISpot)
Time Frame: 7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
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7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
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Cellular immune subgroup: The specific cellular immune response (IL-4) to SARS-CoV-2 (ELISpot)
Time Frame: 7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
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7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
|
Cellular immune subgroup: The specific cellular immune response (IL-13) to SARS-CoV-2 (ELISpot)
Time Frame: 7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
|
7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
|
Cellular immune subgroup: The specific cellular immune response (IFN-γ) to SARS-CoV-2 (ELISpot)
Time Frame: 7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
|
7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination
|
Cross-neutralization subgroup: The cross-neutralizing ability of serum neutralizing antibodies
Time Frame: 14 days and 28 days after the 2nd dose of the initial set of vaccination
|
14 days and 28 days after the 2nd dose of the initial set of vaccination
|
The immunological correlation of risk and protection against symptomatic COVID-19 and SARS-CoV-2 infection
Time Frame: 6 months after initial set of vaccination
|
6 months after initial set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 naive participants
Time Frame: From 14 days after the 2nd dose in the crossover set of vaccination
|
From 14 days after the 2nd dose in the crossover set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 non-naive participants
Time Frame: From 14 days after the 2nd dose in the crossover set of vaccination
|
From 14 days after the 2nd dose in the crossover set of vaccination
|
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 of any severity occurring caused by individual Variants of Concern (VOCs)
Time Frame: From 14 days after the 2nd dose in the initial set of vaccination
|
From 14 days after the 2nd dose in the initial set of vaccination
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LVRNA009-II/III-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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