Clinical trial NCT04683484: A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers
Official title: Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 620
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.

Detailed description: The clinical trial Phase 1, open-label, dose-escalation to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine Nanocovax intramuscularly in healthy Vietnamese adult volunteers.

The clinical trial Phase 2, randomization, double-blind, multicenter, placebo-controlled to evaluate the safety, immunogenicity, and determined the optimal dose of the Vaccine Nanocovax intramuscularly in healthy volunteers.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Solicited adverse events
timeFrame: 7 days after each dose
measure: Anti-S IgG
timeFrame: 0, 7, 28, 35, 56, 180 days after the first dose
Secondary outcomes:
measure: SARS-CoV-2 neutralizing titers
timeFrame: 0, 7, 28, 35, 56, 180 days after the first dose
measure: Participants achieving ≥4-fold rise of Anti-S IgG
timeFrame: 0, 7, 28, 35, 56, 180 days after the first dose
measure: Cellular immune response (IFNγ)
timeFrame: 28, 35, 56 days after the first dose
measure: Cellular immune response (T CD4)
timeFrame: 28, 35, 56 days after the first dose
measure: Cellular immune response (T CD8)
timeFrame: 28, 35, 56 days after the first dose
measure: Serious adverse events
timeFrame: 28 days after each dose
measure: Unsolicited adverse events
timeFrame: 28 days after each dose
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Military Medical Academy
state: Ha Dong
Study officials:
References:
citation: Nguyen TP, Do Q, Phan LT, Dinh DV, Khong H, Hoang LV, Nguyen TV, Pham HN, Chu MV, Nguyen TT, Pham QD, Le TM, Trang TNT, Dinh TT, Vo TV, Vu TT, Nguyen QBP, Phan VT, Nguyen LV, Nguyen GT, Tran PM, Nghiem TD, Tran TV, Nguyen TG, Tran TQ, Nguyen LT, Do AT, Nguyen DD, Ho SA, Nguyen VT, Pham DT, Tran HB, Vu ST, Hoang SX, Do TM, Nguyen XT, Le GQ, Tran T, Cao TM, Dao HM, Nguyen TTT, Doan UY, Le VTT, Tran LP, Nguyen NM, Nguyen NT, Pham HTT, Nguyen QH, Nguyen HT, Nguyen HLK, Tran VT, Tran MTN, Nguyen TTT, Ha PT, Huynh HT, Nguyen KD, Thuan UT, Doan CC, Do SM. Safety and immunogenicity of Nanocovax, a SARS-CoV-2 recombinant spike protein vaccine: Interim results of a double-blind, randomised controlled phase 1 and 2 trial. Lancet Reg Health West Pac. 2022 May 16;24:100474. doi: 10.1016/j.lanwpc.2022.100474. eCollection 2022 Jul.