A study to assess safety and immunogenicity of Biological E’s Covid-19 vaccine in 5-80 year old people.

• Register: CTRI
• Last refreshed on: 4 March 2024
• Main ID: CTRI/2024/01/061423
• Date of registration: 12-01-2024
• Prospective Registration: Yes
• Primary sponsor: Biological E Limited
• Public title: A study to assess safety and immunogenicity of Biological E’s Covid-19 vaccine in 5-80 year old people.
• Scientific title: A prospective single-blind randomized phase-III comparative study to evaluate immunogenicity and safety of Biological E’s XBB.1.5-RBD subunit Covid-19 vaccine in 5-80 years old individuals. - Nil
• Date of first enrolment: 31-01-2024
• Target sample size: 360
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=98111
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Mr Subba Reddy GV
• Affiliation: Biological E.Limited

• Name: Dr Subhash Thuluva
• Affiliation: Biological E.Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1. Ability to provide written informed consent and by the subjects or their parents or legally acceptable representative and also an assent by the children aged between 7 to 18 years

2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol

3. Participants of either gender, aged between 5 to 80 years on the day of screening

4. Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR prior to enrolment.

5.Participants who have not received any COVID-19 related vaccine(s), during the last six months prior to enrolment

6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital sign as defined in the protocol.

7. Subject or his or her LAR agrees not to participate in another clinical trial at any time during the total study period.

8.Subject or his or her LAR willing to allow storage and future use of collected biological samples for future research in an anonymised form.

9.Subject or his or her LAR agrees to remain in the town where the study centre is located, for the entire duration of the study.
Exclusion criteria: 1. Living in the same household of any COVID-19 positive person;

2. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment;

3. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines);

4. Current or planned participation in prophylactic or therapeutic drug trials for the duration of the study.

5.Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment.;

6. Pregnant women, nursing women or women of childbearing potential who are or may not actively avoid pregnancy during the study period;

7. Chronic respiratory disease, including asthma;

8. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;

9. Individuals who are part of the study team or close family members of individuals conducting the study.

10. Anaphylactic reaction following administration of the investigational vaccine.

11. History of severe psychiatric conditions likely to affect participation in the study;

12. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);

13. History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s test or control vaccine formulations;









Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Intervention(s)

Intervention1: Biological Es XBB.1.5 RBD subunit vaccine: Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses 1st at Day 0 and the 2nd dose at Day 28.
Control Intervention1: Biological Es Monovalent Corbevax vaccine: Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses 1st at Day 0 and the 2nd dose at Day 28.

Primary Outcome(s)

1. Immune response measured as determined by geometric mean titre (GMT) of anti-XBB.1.5.RBD neutralizing antibodiesTimepoint: 1. At day 28 and at day 42 in cohorts under Group-1 (test) and Group-2 (control)

Secondary Outcome(s)

Occurrence of any adverse reactionsTimepoint: Within 60 minutes of immediate post vaccination period

Proportion of subjects with =2-fold and =4-fold riseTimepoint: At day 28 and day 42

To assess geometric mean titre (GMT) of, Anti-XBB.1.5-RBD-IgG and PSVNT antibodiesTimepoint: At baseline, Day-28 and Day-42 time-points in both test (Group-1) and control (Group-2) groups

Occurrence of any unsolicited adverse events (AEs), serious AEs (SAEs), medically attended AEs (MAAEs) or AEs of special interest (AESIs) in all study participantsTimepoint: until 28 days’ post vaccination period

Occurrence of any solicited adverse eventsTimepoint: Within 7 consecutive days after each dose

To assess geometric mean fold rise (GMFR) in Anti-XBB-1.5 RBD-IgG and PSVNT antibodiesTimepoint: From baseline at day 28 and again at day 42 in both test (Group-1) and control (Group-2) groups

Secondary ID(s)

BECT083/XBB-Covid-19-Phase-III/CTP-01Ver:1.1 dated: 20.12.23

Source(s) of Monetary Support

Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India.

Ethics review

Status: Approved
Approval date: 08/01/2024
Contact:

Lifepoint Research- Ethics Committee

Status: Approved
Approval date: 11/01/2024
Contact:

Ethics Committee - St. Theresas Hospital,

Status: Not Approved
Approval date:
Contact:

BAPS Hospital Institutional Ethics Committee

Status: Not Approved
Approval date:
Contact:

Gullurkar Hospital Ethics Committee

Status: Not Approved
Approval date:
Contact:

Guru Teg Bahadur Hospital Ethics Committee

Status: Not Approved
Approval date:
Contact:

IEC-Mysore Medical College and Research & Associated Hospital,

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee for ESIC