Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants
- Summary
- An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010)
- Short title
- Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-05-01
- First posted
- 2022-10-31
- Registry last updated
- 2022-11-01
- Primary completion date
- 2023-05-01
- Start date
- 2023-02-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Registry sponsor category
- Industry
- Lead sponsor
- AIM Vaccine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05599802
- ClinicalTrials.gov ID
- NCT05599802
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
Incidence, severity, and duration of each solicited (local and systemic) AE.
Timeframe: Within 30 minutes and 7 days after (each dose of) vaccination
Incidence, severity, and duration of each unsolicited AE.
Timeframe: Within 28 days after (each dose of) vaccination
The percentage of participants with abnormal hematology and chemistry laboratory values.
Timeframe: 4 days after (each dose of) vaccination
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
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
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
GMT of S-protein specific IgG antibodies (ELISA)
Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination
SCR of S-protein specific IgG antibodies (ELISA)
Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination
GMI of S-protein specific IgG antibodies (ELISA)
Timeframe: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination
The incidence, severity, and causality of Serious Adverse Events (SAEs)
Timeframe: Within 12 months after (full) vaccination
The incidence, severity, and causality of Adverse Events of Special Interest (AESI)
Timeframe: Within 12 months after (full) vaccination
The incidence, severity, and causality of the occurrence of pregnancy events
Timeframe: Within 12 months after (full) vaccination
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- Adults aged 18 years and older.
- 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).
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, 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 (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.].
- 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.
- On the day of vaccination and 24 hours prior to (each dose of) vaccination, axillary temperatures<37.3℃/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].
- (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
- (For group 1 only) Not have received any COVID-19 vaccine prior to enrollment.
- Any screening hematology and/or blood biochemistry laboratory value that meets the definition of a ≥Grade 1 abnormality,
- (For group 1 only) Confirmed SARS-CoV-2 diagnosis within 1 years before screening visit.
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections.
- Receipt of medications intended to treat COVID-19 with 1 year.
- 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).
- SARS-CoV-2 RT-PCR positive nasopharyngeal/oropharyngeal swab specimens at screening.
- Positive HIV test at screening.
- 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 of functional asplenia, complete or partial splenectomy from any cause.
- 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.
- 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.
- 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.
- Blood donation or blood loss ≥450ml within 1 month prior to enrollment or planned to donate blood during the study period.
- Participation in other studies involving study intervention within 28 days prior to study entry, and/or during the study.
- Women who are pregnant or breastfeeding.
- Participants deemed unsuitable for participation in this study based on the investigator's assessment.
- (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).
- (For group 1 only: Criteria for delay of 2nd dose of vaccination) During treatment/recovery from illness.
- (For group 1 only: Criteria for delay of 2nd dose of vaccination) Other conditions considered by the investigator to be unsuitable for vaccination.
- (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).
- (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.
- (For group 1 only: Criteria for termination of 2nd dose of vaccination) Positive result for SARS-CoV-2 (positive RT-PCR test).
- (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.
Related records
Drugs (1)
Collaborators (2)
- LiveRNA Therapeutics Inc.
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition