COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=16018

Vincent Mutabazi

mutabazivincent@gmail.com

2021-07-23

Not recruiting

RCT

Randomized

Factorial

Blind label

multi-center

Prevention

Voluntarily participate in this study and sign the informed consent form Adults aged 18 years and older, male or female According to the assessment of the investigator, the participant has a stable medical condition (which is defined as no significant changes in therapy or hospitalization caused by disease aggravation within 3 months before enrollment and are able to and willing to follow the requirements of the protocol Males of reproductive potential and females of child-bearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 12 months after full-course immunization, females of child-bearing potential have negative pregnancy test at screening and at the day of vaccination

History of previous COVID19 infection Positive result for RTPCR test in screening period, or specific antibody IgG or IgM meet the following conditions If both IgG and IgM are negative the participant can be vaccinated without waiting for the RTPCR test results History of severe acute respiratory syndrome SARS middle east respiratory syndrome MERS and other human coronavirus infections or diseases History of severe allergy to any vaccine eg acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain etc or be allergic to any components of V01 Any confirmed or suspected immunosuppression or immunodeficiency condition known from medical history, including human immunodeficiency virus infection asplenia Serious or uncontrolled cardiovascular diseases, nervous system disorders eg Guillain-Barre syndrome blood and lymphatic system disorders, immune system disorders, hepatorenal disorders, respiratory system disorders e g active tuberculosis, pulmonary fibrosis metabolic and skeletal systems disorders or malignant tumors except for skin basal cell carcinoma or in situ carcinoma of uterine cervix that has been cured more than 5 years Hereditary hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic disease, or requirement of continuous use of anticoagulants Prior use of any medications to prevent COVID19 e g use of antipyretics without pyrexia and any other symptoms History of vaccination against SARSCoV2 marketed or investigational Received attenuated live vaccine within 28 days before the first vaccination or any other vaccines licensed or investigational within 14 days before the first vaccination Injection of immunoglobulin and/or other blood products within 3 months before the administration of inves

2

Livzon Mabpharm Inc

18

80

Ghana;Rwanda;Uganda

Healthy volunteers

N/A

22500

Primary ObjectivesEfficacy:To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days (=15 days) after full-course immunization (completing all vaccinations)Safety:To evaluate the incidence of adverse events (AEs) of recombinant SARS-CoV-2 fusion protein vaccine (V-01) from the first vaccination to 28 days after full-course immunization;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "No information on doses", "treatment_id": 1086, "treatment_name": "Recombinant sars-cov-2 fusion protein vaccine (v-01)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]