A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the Immunogenicity, Reactogenicity and Safety of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers.
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; oraltemperature <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
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
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
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
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
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 (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
28. Living in the same household of any COVID-19 positive person (at the
time of screening only).
29. 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
31. Anaphylactic reaction following administration of the investigational
32. Virologically confirmed cases SARS-CoV-2 infection
1. To evaluate the humoral immune
responses of BBV154.
2. To evaluate the reactogenicity and
safety of BBV154 (Adenoviral
vectored based SARS-CoV-2
virus) vaccine administered via the
3. To evaluate the immune responses
against spike protein of SARSCoV-
2 virus and Adenovirus
*To evaluate the vaccine induced
Cell mediated immune response.
* To evaluate the vaccine secretory
IgA antibody response.
* To evaluate the safety of the
vaccine in terms of assessing
adverse event of special interest
*GMT of neutralizing antibodies
(NAb’s) by MNT/PRNT assays
across the two groups, from
baseline to days 6+3, 28+2, 42±2,
90±7 and 180±7
* The occurrence of immediate
adverse events within 2 hours of
vaccination [Time Frame: within 2
hours post each vaccination]
*The occurrence of solicited
adverse events within seven days
of vaccination [Time Frame: 7
*The occurrence of serious adverse
[Time Frame: throughout the study
*The occurrence of any unsolicited
adverse events up to day 35 from
1st dose vaccination. [Time Frame:
up to day 35 from 1st dose
GMTs of binding antibodies
(bAb’s) IgA and IgG against spike
protein across the two groups,
from baseline to days 28+2, 42±2,
90±7 and 180±7.
*Immune response (binding/ or
neutralization) to the vector will be
assessed by ELISA from baseline
to days 28+2, 42±2, 90±7 and
*Vaccine induced cell mediated
immunogenicity and antigen
specific T-cell responses and
cytokines across the two groups,
from baseline to days 6+3, 28+2,
42±2, 90±7 and 180±7.
*GMTs of binding antibodies
(bAb’s) and neutralizing antibody
* The occurrence of adverse
event of special interest (AESI).
[Time Frame: throughout the study
A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the
Immunogenicity, Reactogenicity and Safety of an Intranasal Adenoviral vector
COVID-19 vaccine (BBV154) in Healthy Volunteers.
The study is designed to evaluate the safety, reactogenicity, and
immunogenicity of four groups of healthy volunteers who receive either
intranasal vaccine in the form of drops on day 0 and day 28 (Group 1) or
placebo via intranasal route with either dropper (Group 2). A total of 200
subjects will be enrolled in 4:1 ratio and will be conducted in a double blinded
Group 1 (BBV154-Dropper): In this group, 160 participants will be recruited
and administered with 0.5 mL of vaccine (BBV154) on day 0 and day 28 via
intranasal route with a dropper.
Group 2 (Placebo with Dropper): In this group, 40 participants will be
recruited and administered with placebo on both day 0 and day 28 via
intranasal route with validated dropper.
An interim analysis will be performed at day 42 for Immunogenicity, Safety
and submitted to CDSCO.