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) |
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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 |
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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) | |
Variants description | |
Variants | |
Description * | |
Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes |
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. |