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 :
Multicenter / Vietnam Follow-up duration (months): 6 | |
Nanocovax 25 mcg (n = 161) Nanocovax 50 mcg (n = 160) Nanocovax 75 mcg (n = 159) Placebo (n = 80) |
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Inclusion criteria | Healthy men and nonpregnant women; at least 18 years of age; BMI of 17 to 35; 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 with 0.5 mg aluminum hydroxide adjuvant, 28 days apart 2 IM doses of 50 mcg with 0.5 mg aluminum hydroxide adjuvant, 28 days apart 2 IM doses of 75 mcg with 0.5 mg aluminum hydroxide adjuvant, 28 days apart |
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Control
2 IM doses of 0.05% aluminum hydroxide adjuvant, 28 days apart | |
Participants | |
Randomized 560 participants | |
Characteristics of participants Type of participants: Healthy adults N=560 242 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 19-76 | |
Description of participants Healthy HIV-negative and seronegative adults at 2 centers 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 and laboratory 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 Among 112 serum samples (at day 42) tested on Wuhan strain, a subset of 21 was randomly selected to evaluate neutralizing titer on UK variant (B.1.1.7, also known as the alpha variant). GMT in group 2.1 to 2.3 on UK variant were 35·6 [7·0-180·3], 56·57 [14·51-220·6] and 40 [10·9-147·0], an approximately 1·9-fold decrease, compared to the original strain (figure S6). | |
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 articles, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. The age inclusion criteria were 12-75 years in the registry, but ≥18 years in the article. Otherwise there were no substantive differences between the pre-print article and the trial registry on population, procedures, interventions and outcomes.
This study was updated on October 21st, 2021 with data from the second preprint report (SSRN). This study was updated on June 28th, 2022 after the publication of trial report. |