| Eligibility |
Phase 1:
Inclusion Criteria
1. Ability to provide written informed consent.
2. Participants of either gender of age between =18 to =55 years.
3. Good general health as determined by the discretion of investigator (vital signs
(heart rate =60 to=100 bpm; blood pressure systolic =90 mm Hg and <140 mm Hg;
diastolic = 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and
physical examination).
4. Expressed interest and availability to fulfill the study requirements.
5. For a female participant of child-bearing potential, planning to avoid becoming
pregnant (use of an effective method of contraception or abstinence) from the time of
study enrolment until at least four weeks after the last vaccination
6. Male subjects of reproductive potential: Use of condoms to ensure effective
contraception with the female partner from first vaccination until 3 months after last
vaccination
7. Male subjects agree to refrain from sperm donation from the time of first vaccination
until 3 months after last vaccination
8. Participants must refrain from blood or plasma donation from the time of first
vaccination until 3 months after last vaccination
9. Agrees not to participate in another clinical trial at any time during the study
period.
10. Agrees to remain in the study area for the entire duration of the study.
11. Willing to allow storage and future use of biological samples for future research.
Exclusion Criteria
1. History of any other COVID-19 investigational vaccination.
2. Unacceptable laboratory abnormality from screening (prior to first vaccination) or
safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood
sugar level, Renal function test (serum urea and Creatinine), liver function tests,
urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis
B surface antigen].
(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2
antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary care
provider for follow up of these abnormal laboratory tests.)
3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
4. Health care workers.
5. For women, a positive serum pregnancy test (during screening within 45 days of
enrolment) or positive urine pregnancy test (within 24 hours of administering each
dose of vaccine).
6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an
upper respiratory infection or gastroenteritis within three days prior to each dose of
vaccine.
7. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before
enrollment or expects to receive an investigational agent during the study period.
9. Receipt of any licensed vaccine within four weeks before enrolment in this study.
10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic
reaction and history of allergies in the past.
11. Receipt of immunoglobulin or other blood products within the three months prior to
vaccination in this study.
12. Immunosuppression as a result of an underlying illness or treatment with
immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation
therapy within the preceding 36 months.
13. Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent)
within the preceding six months (nasal and topical steroids are allowed).
14. Any history of hereditary angioedema or idiopathic angioedema.
15. Any history of anaphylaxis in relation to vaccination.
16. Any history of albumin-intolerance.
17. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
18. History of any cancer.
19. History of psychiatric severe conditions likely to affect participation in the study.
20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or
prior history of significant bleeding or bruising following IM injections or
venepuncture.
21. Any other serious chronic illness requiring hospital specialist supervision.
22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including
mild asthma.
23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal
disease, endocrine disorder, and neurological illness
24. Morbidly obese (BMI=35 kg/m2) or underweight (BMI =18 kg/m2).
25. Living in the same household of any COVID-19 positive person.
26. Any other condition that in the opinion of the investigator would jeopardize the
safety or rights of a volunteer participating in the trial or would render the subject
unable to comply with the protocol.
Re-Vaccination Exclusion Criteria
27. Pregnancy.
28. Anaphylactic reaction following administration of the investigational vaccine.
29. Virologically confirmed cases of COVID-19
Phase 2:
Inclusion Criteria
1. Ability to provide written informed consent (Audio video consent for vulnerable
subjects).
2. Participants of either gender of age between =12 to = 65 years.
3. Good general health as determined by the discretion of investigator (vital signs
(heart rate =60 to=100 bpm; blood pressure systolic =90 mm Hg and <140 mm Hg;
diastolic = 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and
physical examination).
4. Expressed interest and availability to fulfill the study requirements.
5. For a female participant of child-bearing potential, avoid becoming pregnant (use of
an effective method of contraception or abstinence) from the time of study enrolment
until at least four weeks after the last vaccination and agrees not to participate in
another clinical trial at any time during the study period.
6. Male subjects of reproductive potential: Use of condoms to ensure effective
contraception with the female partner from first vaccination until 3 months after last
vaccination
7. Male subjects agree to refrain from sperm donation from the time of first vaccination
until 3 months after last vaccination
8. Participants must refrain from blood or plasma donation from the time of first
vaccination until 3 months after last vaccination.
9. Agrees to remain in the study area for the entire duration of the study.
10. Willing to allow storage and future use of biological samples for future research.
Exclusion Criteria
1. History of any other COVID-19 investigational vaccination.
2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
3. Health care workers.
4. Positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
5. Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an
upper respiratory infection or gastroenteritis within three days prior to each dose of
vaccine.
6. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before
enrolment or expects to receive an investigational agent during the study period.
8. Receipt of any licensed vaccine within four weeks before enrolment in this study.
9. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic
reaction and history of allergies in the past.
10. Receipt of immunoglobulin or other blood products within the three months prior to
vaccination in this study.
11. Immunosuppression as a result of an underlying illness or treatment with
immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation
therapy within the preceding 36 months.
12. Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent)
within the preceding six months (nasal and topical steroids are allowed).
13. Any history of hereditary angioedema or idiopathic angioedema.
14. Any history of anaphylaxis in relation to vaccination.
15. Any history of albumin-intolerance.
16. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
17. History of any cancer.
18. History of psychiatric severe conditions likely to affect participation in the study.
19. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or
prior history of significant bleeding or bruising following IM injections or
venepuncture.
20. Any other serious chronic illness requiring hospital specialist supervision.
21. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including
mild asthma.
22. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal
disease, endocrine disorder, and neurological illness
23. Morbidly obese (BMI=35 kg/m2) or underweight (BMI =18 kg/m2).
24. Living in the same household of any COVID-19 positive person.
25. Any other condition that in the opinion of the investigator would jeopardize the
safety or rights of a volunteer participating in the trial or would render the subject
unable to comply with the protocol.
Re-Vaccination Exclusion Criteria
26. Pregnancy.
27. Anaphylactic reaction following administration of the investigational vaccine.
28. Virologically confirmed cases of COVID-19.
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