Intranasal COVID-19 vaccine Phase 2 study in Healthy volunteers
- Registration Number
- CTRI/2021/09/036257
- Lead Sponsor
- Bharat Biotech International Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion
1. Ability to provide written informed consent
2. Participants of either gender of age between >=18 to <=60 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 fulfil 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
1. History of any other COVID-19 investigational/or licensed vaccination.
2. Unacceptable laboratory abnormality at screening (prior to first vaccination) or safety
testing, as listed below
3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
4. Any history of facial nerve paralysis
5. History of cold, sneezing, nasal obstruction in the past 3 days.
6. Prescribed usage of any nasal spray/or nasal drop medication.
7. Any significant abnormality altering the anatomy of the nose in a substantial way or
nasopharynx that may interfere with the aims of the study and in particular any of the nasal
assessments or viral challenge (historical nasal polyps can be included, but large nasal
polyps causing current and significant symptoms and/or requiring regular treatments in the
last month are excluded)
8. For women of child bearing potential, 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).
9. 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.
10. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
11. 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.
12. Receipt of any licensed vaccine within four weeks before enrolment in this study.
13. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction
and history of allergies in the past.
14. Receipt of immunoglobulin or other blood products within the three months prior to
vaccination in this study.
15. 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.
16. 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).
17. Any history of hereditary angioedema or idiopathic angioedema.
18. Any history of anaphylaxis in relation to vaccination.
19. Any history of albumin-intolerance.
20. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
21. History of any cancer.
22. History of severe psychiatric severe conditions likely to affect participation in the study.
23. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior
history of significant bleeding or bruising following IM injections or venepuncture.
24. Any other serious chronic illness requiring hospital specialist supervision.
25. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild
asthma.
26. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease,
endocrine disorder, and neurological illness
27. Morbidly obese (BMIâ?
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GMT of neutralizing antibodies (NAbâ??s) by MNT/PRNT assays across the two groups.Timepoint: days 0, 28, 42, 90 and 180
- Secondary Outcome Measures
Name Time Method The occurrence of immediate adverse events and Serious adverse evnts <br/ ><br>Timepoint: days 0, 28, 42, 90 and 180