A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers
Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen
1 other identifier
interventional
620
1 country
1
Brief Summary
The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2020
CompletedFirst Submitted
Initial submission to the registry
December 18, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2021
CompletedDecember 29, 2020
December 1, 2020
6 months
December 18, 2020
December 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Solicited adverse events
Percentage and severity level of participants reporting Solicited adverse events
7 days after each dose
Anti-S IgG
Geometric mean concentrations of Anti-S IgG at each time points
0, 7, 28, 35, 56, 180 days after the first dose
Secondary Outcomes (7)
SARS-CoV-2 neutralizing titers
0, 7, 28, 35, 56, 180 days after the first dose
Participants achieving ≥4-fold rise of Anti-S IgG
0, 7, 28, 35, 56, 180 days after the first dose
Cellular immune response (IFNγ)
28, 35, 56 days after the first dose
Cellular immune response (T CD4)
28, 35, 56 days after the first dose
Cellular immune response (T CD8)
28, 35, 56 days after the first dose
- +2 more secondary outcomes
Study Arms (4)
Low dose of Nanocovax
EXPERIMENTALIntramuscular injection, two doses given 28 days apart
Middle dose of Nanocovax
EXPERIMENTALIntramuscular injection, two doses given 28 days apart
High dose of Nanocovax
EXPERIMENTALIntramuscular injection, two doses given 28 days apart
Placebo
PLACEBO COMPARATORIntramuscular injection, two doses given 28 days apart
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Military Medical Academy
Hanoi, Ha Dong, Vietnam
Related Publications (1)
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.
PMID: 35602004DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2020
First Posted
December 24, 2020
Study Start
December 10, 2020
Primary Completion
June 10, 2021
Study Completion
August 10, 2021
Last Updated
December 29, 2020
Record last verified: 2020-12