A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers (NCT04683484) | Clinical Trial Compass
UnknownPhase 1/2
A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers
Vietnam620 participantsStarted 2020-12-10
Plain-language summary
The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.
Who can participate
Age range12 Years – 75 Years
SexALL
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Inclusion Criteria:
* From 18 to 50 years old in phase 1, from 12 to 75 years old in phase 2
* Body Mass Index (BMI) between 18 and 28 kg/m2
* The subject has good health, is assessed through medical history, clinical examination, and laboratory tests (such as hematology, biochemistry, urine ...) within the normal range evaluated by the clinician.
* Subjects aged potentially pregnant should use effective contraceptive methods 4 weeks prior to screening and during the study and last until 6 months after the last injection.
* Able and willing to participate in all activities in the clinical trial, including 6-month follow-up after vaccination.
* Sign the consent form. For a subject from 12 to 17 years old, it is necessary to have a legal guardian sign the consent form to participate in the study
Exclusion Criteria:
* Insufficient civil act capacity.
* Subjects at high risk of SARS-CoV-2 infection.
* Subject is/has ever had any acute or chronic medical condition, including but not limited to:
* Have any inflammatory disease, respiratory tract infection, have any respiratory symptoms such as: cough, sore throat, difficulty breathing, wheezing due to respiratory symptoms within 07 days before screening. Fever (armpit temperature ≥ 37°C) for 3 days before vaccination.
* History of any chronic respiratory illness such as bronchial asthma, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease (COPD).
* Malignant disease
* Immune disorders, using immun…
What they're measuring
1
Solicited adverse events
Timeframe: 7 days after each dose
2
Anti-S IgG
Timeframe: 0, 7, 28, 35, 56, 180 days after the first dose
Trial details
NCT IDNCT04683484
SponsorNanogen Pharmaceutical Biotechnology Joint Stock Company