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COVID-19Phase 1/2NCT04683484

A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers

A Phase 1/2 study testing Nanocovax in people with COVID-19, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers. Read more about this study

Who is it for?
Ages 12 to 75 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Nanocovax
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
620 participants
Where
1 siteVietnam
Study dates
10 Dec 2020to 10 Aug 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Nhan Ho, PhD contact

(+84) 28 7108 9688

clinicaltrial@nanogenpharma.com

Vietnam1 site, 1 recruiting

  • Military Medical Academy

    Hanoi, Ha Dong

    Men chu, MD, +84 388 959 096

    Recruiting

Other trials in Vietnam

About this study

Official title: Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen

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

Read the 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.

Conditions
COVID-19
Being tested
Nanocovax, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NanocovaxBiological

    Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)

  • PlaceboBiological

    0,5 mg Al PO4

Study groups in NCT04683484
Study groupRoleWhat they receive
Low dose of NanocovaxExperimentalIntramuscular injection, two doses given 28 days apart
Receives: Biological: Nanocovax
Middle dose of NanocovaxExperimentalIntramuscular injection, two doses given 28 days apart
Receives: Biological: Nanocovax
High dose of NanocovaxExperimentalIntramuscular injection, two doses given 28 days apart
Receives: Biological: Nanocovax
PlaceboPlacebo comparatorIntramuscular injection, two doses given 28 days apart
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Solicited adverse events

    Percentage and severity level of participants reporting Solicited adverse events

    Measured: 7 days after each dose

  2. Anti-S IgG

    Geometric mean concentrations of Anti-S IgG at each time points

    Measured: 0, 7, 28, 35, 56, 180 days after the first dose

Secondary outcomes (7)

  1. SARS-CoV-2 neutralizing titers

    Geometric mean titers of SARS-CoV-2 Neutralization antibody at each time points

    Measured: 0, 7, 28, 35, 56, 180 days after the first dose

  2. Participants achieving ≥4-fold rise of Anti-S IgG

    Proportion of participants achieving ≥4-fold rise of Anti-S IgG from before vaccination at each time points

    Measured: 0, 7, 28, 35, 56, 180 days after the first dose

  3. Cellular immune response (IFNγ)

    Change of IFNγ from baseline after vaccination

    Measured: 28, 35, 56 days after the first dose

  4. Cellular immune response (T CD4)

    Change of T CD4 from baseline after vaccination

    Measured: 28, 35, 56 days after the first dose

  5. Cellular immune response (T CD8)

    Change of T CD8 from baseline after vaccination

    Measured: 28, 35, 56 days after the first dose

  6. Serious adverse events

    Percentage of participants reporting Serious adverse events

    Measured: 28 days after each dose

  7. Unsolicited adverse events

    Percentage of participants reporting Unsolicited adverse events

    Measured: 28 days after each dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start10 Dec 2020
  3. Primary completion10 Jun 2021 (estimated)
  4. Study completion10 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
620 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683484
Sponsor's protocol ID
NNG26
Status last verified
Dec 2020
First submitted
18 Dec 2020
Last updated
29 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35602004

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nanocovax in people with COVID-19, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nhan Ho, PhD ((+84) 28 7108 9688, clinicaltrial@nanogenpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited adverse events (time frame: 7 days after each dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04683484, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

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