A Global Multi-center Clinical Study of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19

NCT05682638 | Unknown Phase 3 DMC

• 1 other identifier: LVRNA009-II/III-01
• Study Type: interventional
• Target: 34,000
• Locations: 1 country
• Sites: 1

Brief Summary

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 (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older

Conditions

SARS-CoV-2

Keywords

mRNA, Prevention

Outcome Measures

Primary Outcomes (1)

• 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

  From 14 days after the 2nd dose in the initial set of vaccination

Secondary Outcomes (25)

• The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 for SARS-CoV-2 naive participants

  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

  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

  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)

  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

  From 14 days after the 2nd dose in the initial set of vaccination

Other Outcomes (9)

• Cellular immune subgroup: The specific cellular immune response (IL-2) to SARS-CoV-2 (ELISpot)

  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-4) to SARS-CoV-2 (ELISpot)

  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)

  7 days, 14 days, 28 days after the 2nd dose of the initial set of vaccination

Study Arms (2)

Vaccine group

EXPERIMENTAL

Phase 3(Base the result of Phase 1 and Phase 2, intervent 100μg): initial vaccination stage- LVRNA009; crossover vaccination stage- placebo

Biological: LVRNA009; Other: 0.9%NaCl

Control group

PLACEBO COMPARATOR

Phase 3: initial vaccination stage- placebo; crossover vaccination stage- LVRNA009

Biological: LVRNA009; Other: 0.9%NaCl

Interventions

LVRNA009 BIOLOGICAL

100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart

Control group; Vaccine group

0.9%NaCl OTHER

1.0ml/dose, 2 injection with 28 days apart

Control group; Vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• AIM Vaccine Co., Ltd.: lead
• AIM Innovation Biotechnology (Shanghai) Co., Ltd: collaborator
• Ningbo Rongan Biological Pharmaceutical Co., Ltd.: collaborator
• LiveRNA Therapeutics Inc.: collaborator

Study Sites (1)

KEMRI CRDR Research Annex, Siaya Country Referral Hospital

Siaya, 144-40600, Kenya

RECRUITING

MeSH Terms

Interventions

LVRNA009 COVID-19 vaccine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Videlis Nduba, PHD

CONTACT

254-724-52247; vnduba@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 12, 2023
• Study Start: January 30, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 21, 2023

Record last verified: 2022-08

Locations

KE (1)