Covid-19 Living Data

Trial NCT04683484
Publication Nguyen T, Lancet, 2022

Funding: Mixed (Nanogen Pharmaceutical Biotechnology JSC., and the Ministry of Science and Technology of Vietnam)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / Vietnam Follow-up duration (months): 2
	Nanocovax 25 mcg (n = 20) Nanocovax 50 mcg (n = 20) Nanocovax 75 mcg (n = 20)
Inclusion criteria	Healthy men and nonpregnant women 18 to 50 years of age body-mass index (BMI) of 18 to 27 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.
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: any inflammatory disease, respiratory tract infection, have any respiratory symptoms History of any chronic respiratory illness such as bronchial asthma, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease (COPD) Malignant disease Immune disorders, using immunosuppressive therapy Cardiovascular diseases (including high blood pressure requiring drug treatment), liver disease, chronic kidney disease, endocrine diseases (including diabetes), hemoglobin disease Neurological, psychiatric, epilepsy, or Guillian-Barré disorders Pathology of hemostasis Having any surgery for 8 weeks before screening History of organ transplantation Examination and testing results at the time of screening: Systolic pressure above 140 mmHg and/or diastolic pressure over 90mmHg Systolic blood pressure less than 90 mmHg and/or diastolic pressure below 50 mmHg Real-Time nasopharyngeal fluid test - PCR (positive) and/or anti S - IgG (positive) with SARS-CoV-2 Women of potential pregnancy, a positive urine beta-hCG test at the time of screening Positive with HIV, hepatitis B (HBsAg), hepatitis C (ANTI-HCV) tests WBC less than 3.5 x 10^9 cells / L Lymphocytes of less than 1.0 x 10^9 cells / L. Neutrophils less than 2.0 x 10^9 cells / L Platelets below 140 x 10^9 cells / l Hb less than 120 g/L for men and less than 100 g/L for women ALT or AST is over 2 times the normal limit eGFR of 90 mL/min/ 1.73m2 or less Abnormal ECG of clinical significance The Subject who have taken any drugs or treatments simultaneously and before: Any drug or treatment that affects the immune system such as injectable anti-allergenic drugs, Globulin, Interferon, immunomodulators, cytotoxic drugs, or any other drug toxic to the body, for 90 days before screening Systemic steroids (oral or injectable including intra-articular injection) regardless of dose except for topical form, for 28 days prior to screening Any vaccine within 28 days prior to screening or planned for in-study vaccination or after 6 months after the first vaccination Receive or donate blood/serum during the 8 weeks prior to the screening, or plan to receive or donate blood/serum during the study period The Subject that participated in any clinical trial 28 days prior to the screening date or intends to participate in another clinical study at any point in the study Women who are pregnant and breastfeeding or planning to become pregnant for the next 6 months from the time of the study 2 vaccines The Subject has a history of allergy to any of the vaccine components understudying or has a history of at least one past history of allergic or hypersensitivity reactions The Subject addicted to alcohol (drinking from 5 cups of alcohol daily, glasses of alcohol/can of beer), tobacco/water pipe addicts (smoking from 5 or more cigarettes), drug addiction, opioid dependence The Subject is a member of the research team, sponsor employee, producer (Nanogen), and a person related by family (wife, husband, child, father, mother) with those subjects.
Interventions
	Intervention 2 IM doses of 25 mcg, 28 days apart 2 IM doses of 50 mcg, 28 days apart
	Control 2 IM doses of 75 mcg, 28 days apart
Participants
	Randomized 60 participants
	Characteristics of participants Type of participants: Healthy adults N=60 23 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 20-43
	Description of participants Healthy HIV-negative and seronegative adults at a single center in Vietnam
Primary outcome
	In the register 1. Solicited adverse events [ Time Frame: 7 days after each dose ]; 2. Anti-S IgG [ Time Frame: 0, 7, 28, 35, 56, 180 days after the first dose ]
	In the report Number and percentage of participants with solicited local and systemic adverse events occurred within 7 days after vaccination andlaboratory results (serum biochemistry and hematology) at days 0, 7, 28, 35 according to FDA toxicity scoring; anti-S IgG responses to Nanocovax evaluated by chemiluminescence immunoassay (CLIA)
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes Data accessibility: Data will be provided upon request. Corresponding author: Do Minh Si, PhD Email: minhsi@nanogenpharma.com
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. There were no substantive differences between the pre-print article and the trial registry on population, procedures, interventions and outcomes. Phase 1 dose-escalating study with no placebo control group and only safety outcomes. This trial was updated on June 22nd, 2022 after publication of study report.