Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) administered 0.5ml of vaccine on day 0 and day 28 via intra-nasal route using a dropper
Whole-Virion Inactivated SARS-CoV-2 vaccine (COVAXIN®) will be administered at day 0 and day 28 via intramuscular route.
1. Ability to provide written informed consent.
2. Participants of either gender of age ≥18 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 mmHg; 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. Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after last vaccination
8. Agrees not to participate in another clinical trial at any time during the study period.
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.
1. History of any other COVID-19 investigational/or licensed vaccination.
2. 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).
3. Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness
such as an upper respiratory infection or gastroenteritis within three days prior
to each dose of vaccine.
4. Medical problems because of alcohol or illicit drug use during the past 12
5. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days
before enrolment or expects to receive an investigational agent during the
6. Receipt of any licensed vaccine within four weeks before enrolment in this
7. Known sensitivity to any ingredient of the study vaccines, or a more severe
allergic reaction and history of allergies in the past.
8. Receipt of immunoglobulin or other blood products within the three months
prior to vaccination in this study.
9. 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.
10. 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
11. Any history of anaphylaxis in relation to vaccination.
12. History of any cancer.
13. History of severe psychiatric conditions likely to affect participation in the
14. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder,
or prior history of significant bleeding or bruising following IM injections or
15. Any other serious chronic illness requiring immediate hospital specialist
16. 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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
1. Geometric mean titres (GMTs) of Serum neutralising antibody titer
(NAb’s) by neutralizing antibody
2.The occurrence of solicited adverse
3. The occurrence of serious adverse
4. The occurrence of any unsolicited
1. day 0, 28, 42, 90 and 180.
3. Through out the study
4. Up to day 42 from 1st dose of vaccination
1. Geometric mean titers of salivary IgA, Serum IgA and
IgG binding antibody titer by ELISA assays.
2. Geometric mean titers of Serum neutralizing antibody titer by neutralizing antibody assays.
3. The occurrence of adverse event of special interest (AESI).
4. Vaccine-induced cell mediated immunogenicity and antigen specific T-cell and B-cell responses.
5. The occurrence of the vaccine induced thrombosis and thrombocytopenia in participants reporting the respective
symptoms and signs.
1. Day 0, 28, 42, 90 and 180
2. Day 0, 28 and 42
3. Throughout the study
Target Sample Size
Total Sample Size="3160" Sample Size from India="3160" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
A Phase III randomized open label multi-center study to compare immunogenicity and
safety of BBV154 with COVAXIN®, and to assess Lot to Lot Consistency of BBV154 in
A total sample size of 3160 healthy volunteer’s age’s ≥18 years will be recruited in
Group 1 (BBV154): In this group, 3000 participants will be recruited, randomized in
1:1:1 ratio receive 3 consecutive lots (Lot 1: 1000, Lot 2: 1000, Lot 3: 1000) of the
BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route.
Group 2 (COVAXIN®): In this group, 160 participants will be recruited and
administered with COVAXIN® vaccine on day 0 and on day 28 via intramuscular