Clinical trial: A Study to Evaluate Safety and Immunogenicity of DelNS1-nCoV-RBD LAIV for COVID-19 (NCT04809389)

Eligibility criteria:
Inclusion Criteria:

          1. Informed Consent: The subject (or the subject's legally acceptable representative, if
             applicable) must be capable of giving written informed consent and, prior to the
             commencement of any study-specific procedure, must sign an ICF indicating the consent
             on the subject's voluntary participation in the study and compliance with the
             requirements and restrictions listed on the ICF.

          2. Gender and Age: Male or female, at the age of ≥ 18 and ≤ 55 on the day of signing the
             ICF.

          3. Body Weight and BMI: Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and < 25 kg/m2 at
             screening and baseline.

          4. Medical Conditions or Diagnoses: Existence of all of the following medical conditions
             or diagnoses:

               1. Generally in good health with no clinically significant abnormality, as
                  determined by medical history, physical examination, 12-lead ECG and clinical
                  laboratory tests at screening and baseline;

               2. Normal vital signs at screening and baseline, as defined by:

                    -  Body (tympanic) temperature ≤ 37.5oC;

                    -  Resting pulse rate ≥ 50 and ≤ 100 bpm; and

                    -  DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.

          5. Contraception: Willingness and agreement to undertake measures to avoid pregnancy of
             the subject or the subject's sexual partner(s) as detailed below:

               1. A female subject who is a woman of childbearing potential (WOCBP) must be willing
                  and agree to remain abstinent or practise at least one effective contraceptive
                  method from at least 30 days prior to the first vaccination until 60 days after
                  the second vaccination;

               2. A male subject (i) who is sexually active with a WOCBP (except who is permanently
                  sterile by bilateral orchiectomy or vasectomy) must be willing and agree to
                  remain abstinent or practise at least one effective contraceptive method from the
                  first vaccination until 60 days after the second vaccination; and (ii) must be
                  willing and agree to refrain from sperm donation during the aforesaid period.

          6. Breastfeeding: A female subject must be willing and agree to avoid engagement in
             breastfeeding at any time from the first vaccination until 60 days after the second
             vaccination.

          7. Blood Donation: Willingness and agreement to avoid blood donation from screening to
             the end of the period of participation in this study.

        Exclusion Criteria:

          1. Medical History: History of any of the following diseases or conditions:

               1. COVID-19;

               2. SARS;

               3. Any significant respiratory diseases (e.g. COPD, asthma);

               4. Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);

               5. Blood dyscrasias or any significant disorder of coagulation;

               6. Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);

               7. Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);

               8. Any malignant neoplastic disease;

               9. Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;

              10. Any psychiatric disorder, psychotic disorder, major affective disorder or
                  suicidal ideation;

              11. Any immunodeficiency or autoimmune disease;

              12. Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance,
                  which requires hospitalization or emergency medical care;

              13. Any hypersensitivity to (especially anaphylactic reactions) to eggs, egg proteins
                  or gentamicin sulfate;

              14. Any chronic rhinitis, nasal septal defect, cleft palate, nasal polyps or other
                  nasal abnormality that might affect vaccine administration;

              15. History of alcohol or illicit drug abuse, or used any illicit drug within 6
                  months prior to screening.

          2. Medical Conditions or Diagnoses: Existence of any of the following medical conditions
             or diagnoses:

               1. Positive serum pregnancy test at screening or positive urine pregnancy test at
                  baseline (for WOCBP);

               2. IgE level > 1,000 U.I./ml at screening;

               3. Positive SARS-CoV-2 test result in serum, deep throat saliva (DTS) or
                  nasopharyngeal swab (NPS) within 4 days prior to baseline;

               4. T3, T4 or TSH < LLN or > ULN at screening;

               5. Positive HIV test result at screening;

               6. Positive HBsAg test result at screening;

               7. Positive HCV antibody test result at screening;

               8. Positive T-cell interferon-γ release assay (TIGRA) result (i.e. by
                  QuantiFERON®-TB Gold Plus™ test) at screening (Remark: A single repeat will be
                  allowed with an indeterminate result);

               9. Positive urine drug screen test result or positive blood alcohol test result at
                  screening or baseline;

              10. Any clinical significant findings (e.g. active or acute cardiac/pulmonary
                  diseases) of chest X-ray at screening.

          3. Prior/Concomitant Interventions: Use of or undergoing any of the following prior or
             concomitant medications, therapies or interventions:

               1. Any COVID-19 or coronavirus vaccine at any time prior to the first vaccination,
                  or planned use of any such vaccine throughout the study;

               2. Any vaccine other than COVID-19 or coronavirus vaccines within 28 days prior to
                  the first vaccination, or planned use of any such vaccine up to 28 days after the
                  second vaccination;

               3. Any immune-modifying medication/therapy (e.g. immunomodulator and
                  immunosuppressant) within 6 months prior to the first vaccination, or planned use
                  of any such medication/therapy throughout the study;

               4. Any blood product (including blood transfusion) or immunoglobulin within 3 months
                  prior to the first vaccination, or planned use of any such therapy throughout the
                  study;

               5. Any anticoagulation medication within 28 days prior to the first vaccination, or
                  planned use of any such medication up to 28 days after the second vaccination;

               6. Any psychotropic medication within 28 days prior to the first vaccination, or
                  planned use of any such medication up to 28 days after the second vaccination;

               7. Regular use of any inhaled/nebulized corticosteroid;

               8. Any intranasal preparation within 48 hours prior to the first vaccination, or
                  planned use of any such preparation up to 48 hours after the second vaccination;

               9. Any influenza antiviral medication within 48 hours prior to the first
                  vaccination, or planned use of any such medication up to 14 days after the second
                  vaccination;

              10. Any prescription or over-the-counter medication or supplement product (e.g.
                  vitamin, dietary supplement, herbal preparation) within 7 days prior to the first
                  vaccination, unless with the investigator's approval for managing a chronic
                  condition;

              11. Donated ≥ 450 ml of blood within 28 days prior to the first vaccination;

              12. Prior nasal surgery or nasal cauterization.

          4. Prior/Concurrent Clinical Study: Prior or concurrent participation in any other
             clinical study, including:

               1. Prior or current participation in another COVID-19 vaccine study;

               2. Prior participation in any interventional clinical study and use of any
                  investigational intervention within 90 days prior to the first vaccination;

               3. Concurrent participation or plan for participation in another interventional
                  clinical study during participation in this study.

          5. Other Significant Medical Conditions: Any clinically significant concomitant disease
             or condition that, in the reasonable opinion of the investigator, may interfere with
             the subject's participation in this study or pose an unacceptable safety risk for the
             subject's participation in this study.

          6. Special Conditions: Existence of any of the following special conditions:

               1. Close contact with anyone known to have COVID-19 within 30 days prior to the
                  first vaccination;

               2. Travelled outside Hong Kong within 14 days prior to the first vaccination;

               3. Planned to travel outside Hong Kong at any time during the period from screening
                  to Day 57(±3) visit.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? 0