COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23630

Fan Zhang

fan.zhang@aimbio.com

2022-04-08

Not recruiting

RCT

Randomized

Crossover

Blind label

multi-center

Prevention

(1) Adults aged 18 years and older. (2) Understand the content of the ICF and the clinical study, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to limited literacy, 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) During the screening period and within 72 hours prior to the 1st dose, 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].

1. History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections 2. Individuals using prescription medications for prophylaxis or treatment of SARS-CoV-2(including vaccination of licensed COVID-19 vaccines) 3.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, not receiving adequate treatment, at potential risk of recurrence during the study 9.Asplenia or functional asplenia, complete or partial splenectomy from any cause. 10.Prolonged (defined as >14 days) use of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, =20mg/d prednisone or equivalent, however, inhaled and topical steroids are permitted) within 6 months prior to the 1st dose of study 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 blood products within 3 months prior to enrollment or plan to receive them during the study. 13.Blood donation or blood loss = 450 mL within 1 month prior to enrollment or planned to donate blood during the study 14.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 study 15.Pregnant or breastfeeding women 16.Deemed unsuitable to participate in this study as assessed by investigator

3

AIM Vaccine Co. Ltd

18

100

Burkina Faso;Ghana;Mali;Nigeria;Sierra Leone;Uganda;United Republic Of Tanzania

Healthy volunteers

N/A

34000

The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis occurring from 14 days after the 2nd dose in the initial set of vaccination in SARS-CoV-2 naive participants in the LVRNA009 (50 µg) dose group.

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"arm_notes": "50\u03bcg", "treatment_id": 1970, "treatment_name": "Lvrna009", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100\u03bcg", "treatment_id": 1970, "treatment_name": "Lvrna009", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]