COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05812014

Xinhui Chen

xinhui.chen@aimbio.com

2023-04-13

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: 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 first vaccination and must agree to continue such precautions during the study until 3 months after booster 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 booster vaccination in this study； on the day 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]; participants who have received primary/1 booster dose(s) of sars-cov-2 vaccination (including primary series of inactivated vaccine, mrna vaccine, adenovirus vaccine or 1 homologous/heterologous booster), with the last dose received at least 6 months before enrolment. documented confirmation of prior sars-cov-2 vaccination receipt must be obtained prior to randomization;

history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers), or other coronavirus infections at any time; history of hepatitis a, hepatitis b, hepatitis c, syphilis infection based on medical inquiry.; history of severe adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s); receipt of medications intended to treat covid-19 within 6 months; virologically confirmed sars-cov-2 diagnosis within 6 months before screening visit; positive nasopharyngeal/oropharyngeal swab sars-cov-2 rt-pcr test result at screening; positive hiv test result 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 or 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 vaccination, planned administration of any other vaccines within 28 days after vaccination, or planned administration of other covid-19 vaccines during the entire study duration; receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 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 ≥ 450 ml 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.

2

AIM Vaccine Co., Ltd.

18

100

Pakistan

Healthy volunteers

N/A

9800

Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19

None

Phase 3

[{"arm_notes": "", "treatment_id": 2611, "treatment_name": "Lvrna021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]