Clinical trial NCT04918797: COVAXIN in a Pediatric Cohort
Official title: A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers Ages ≤18 to ≥ 2 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: SARS-CoV2 Infection
Lead sponsor: Bharat Biotech International Limited
Sponsor class: INDUSTRY
First posted: 2021-06-09
Enrollment: 525
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: PREVENTION

Brief summary: The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - \>12, ≤12 -\>6, ≤ 6 - \>2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart.

Data will be un-blinded to the third party bio-statistician and an interim analysis will be performed on day 56 for Immunogenicity, Safety and submitted to CDSCO.

Detailed description: Study design: A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity, of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers ages ≤18 to ≥2 Years.

A total sample size of 525 healthy volunteers.

The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - \>12, ≤12 -\>6, ≤ 6 - \>2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart.

Group1: A total of 175 healthy volunteers ages ≤18-\>12, years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2.

Group 2: A total of 175 healthy volunteers ages ≤12-\>6, years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2.

Group 3: A total of 175 healthy volunteers ages ≤6-\> 2 years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2.

Data will be un-blinded to the third party bio-statistician and an interim analysis will be performed on day 56 for Immunogenicity, Safety and submitted to CDSCO.

Immunogenicity analysis: A total of 5 ml of blood is collected at days 0, 28+2, 56±7, 118±7 and 208±7. SARS-CoV-2 test will be conducted at the time of screening using RT-PCR and ELISA method.

Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent (by the parents or legally acceptable/authorized representative (LAR) and assent by the children (verbal/oral assent for the children of age between 7-12 years, and written assent for the children of age between \>12 to 18 years), and Audio video consent for all participants.
2. Participants of either gender of age between ≥2 to ≤18years (Participant should be ≤18 years at the time of Screening of the study).
3. Good general health as determined by the discretion of investigator.
4. Expressed interest and availability to fulfill the study requirements.
5. Agrees not to participate in another clinical trial at any time during the study period.
6. Agrees to remain in the study area for the entire duration of the study.
7. 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. 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.
4. 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.
5. Receipt of any licensed vaccine within four weeks before enrollment in this study.
6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
8. 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.
9. 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).
10. Any history of hereditary angioedema or idiopathic angioedema.
11. Any history of anaphylaxis in relation to vaccination.
12. History of congenital diseases.
13. Any history of albumin-intolerance.
14. History of any cancer.
15. History of psychiatric severe conditions likely to affect participation in the study.
16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
17. Any other serious chronic illness requiring hospital specialist supervision.
18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration.
21. 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
22. Anaphylactic reaction following administration of the investigational vaccine.
23. Virologically confirmed cases of COVID-19

Primary outcomes:
measure: Reactogenicity
timeFrame: Within 7 days after each dose of vaccination
measure: Immunogenecity
timeFrame: 6 months
Secondary outcomes:
measure: Immunogenicity
timeFrame: 6 months
Other outcomes:
measure: Unsolicited Adverse Events
timeFrame: Within 28 days after each dose of vaccination
measure: Adverse Events of Special Interest
timeFrame: Through study completion ,an average of 9 months
Locations:
city: Visakhapatnam
country: India
facility: Victoria Government Hospital
state: Andhra Pradesh
city: Patna
country: India
facility: All India Institute of Medical Sciences
state: Bihar
city: Mysore
country: India
facility: Cheluvambha Hospital
state: Karnataka
city: Nagpur
country: India
facility: Meditrina Institute of Medical Sciences
state: Maharashtra
city: Ajmer
country: India
facility: Jawahar Lal Nehru Medical college
state: Rajasthan
city: Hyderabad
country: India
facility: Pranam Hospitals Hyderabad
state: Telangana
city: Kanpur
country: India
facility: Prakhar Hospital
state: Uttar Pradesh
Study officials:
affiliation: Meditrina Institute of Medical Sciences,Nagpur
name: Dr.Vasant Khalatkar, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prakhar Hospital Pvt Ltd.,Kanpur
name: Dr.V.N Tripathi, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Victoria Government Hospital
name: Dr Padmavathi I V, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Scienes,Patna
name: Dr.Lokesh Kumar Tiwari, MBBS,DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: JLN Medical college,Ajmer
name: Dr.Jai Prakash Narayan, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pranam Hospitals Hyderabad
name: Dr Mirza Nizam Baig, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheluvambha Hospital,Mysore
name: Dr Prashanth Siddiah, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vadrevu KM, Reddy S, Jogdand H, Ganneru B, Mirza N, Tripathy VN, Singh C, Khalatkar V, Prasanth S, Rai S, Ella R, Blackwelder W, Prasad S, Ella K. Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2-18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study. Lancet Infect Dis. 2022 Sep;22(9):1303-1312. doi: 10.1016/S1473-3099(22)00307-3. Epub 2022 Jun 16.