Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers

NCT04471519 | Completed Phase 1 DMC

• 2 other identifiers: BBIL/BBV152-A/2020Protocol No:BBIL/BBV152-A/2020
• Study Type: interventional
• Target: 755
• Locations: 1 country
• Sites: 12

Brief Summary

Double blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three investigational vaccine groups and one placebo group in healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2 studies, respectively. A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or placebo.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

BBV152; COVID-19 vaccine; inactivated vaccine

Outcome Measures

Primary Outcomes (2)

• Phase 1: Occurrence of adverse events and Serious Adverse events

  Safety

  Through study completion, an average of 6 months

• Phase 2: Evaluation of Neutralizing Antibody Titers

  Pre- and Post-vaccination immune response

  Through study completion, an average of 6 months

Secondary Outcomes (3)

• Phase 1: Evaluation of Neutralizing Antibody Titers

  Through study completion, an average of 6 months

• Phase 2: Occurrence of adverse events and Serious Adverse events

  Through study completion, an average of 6 months

• Phase 2: Evaluation of Neutralizing Antibody Titers

  Through study completion, an average of 6 months

Study Arms (6)

BBV152A - Phase I

EXPERIMENTAL

0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152A\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14

Biological: BBV152A - Phase I

BBV152B - Phase I

EXPERIMENTAL

0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152B\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14

Biological: BBV152B - Phase I

BBV152C - Phase I

EXPERIMENTAL

0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152C\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14

Biological: BBV152C - Phase I

Placebo - Phase I

ACTIVE COMPARATOR

0.5 mL of Placebo will be administered intramuscularly twice at Day 0 and Day 14.

Biological: Placebo - Phase I

BBV152A - Phase II

EXPERIMENTAL

0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152A\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28.

Biological: BBV152A - Phase II

BBV152B - Phase II

EXPERIMENTAL

0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152B\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28

Biological: BBV152B - Phase II

Interventions

BBV152A - Phase I BIOLOGICAL

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

BBV152A - Phase I

BBV152B - Phase I BIOLOGICAL

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

BBV152B - Phase I

BBV152C - Phase I BIOLOGICAL

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

BBV152C - Phase I

Placebo - Phase I BIOLOGICAL

0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14

Placebo - Phase I

BBV152A - Phase II BIOLOGICAL

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28

BBV152A - Phase II

BBV152B - Phase II BIOLOGICAL

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28

BBV152B - Phase II

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent.
• Participants of either gender of age between ≥18 to ≤55 years.
• 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).
• Expressed interest and availability to fulfill the study requirements.
• 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
• 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
• Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
• Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination
• Agrees not to participate in another clinical trial at any time during the study period.
• Agrees to remain in the study area for the entire duration of the study.
• Willing to allow storage and future use of biological samples for future research.

You may not qualify if:

• History of any other COVID-19 investigational vaccination.
• Unacceptable laboratory abnormality from screening (prior to first vaccination) or safety testing, as listed below \[Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen\].
• (Subjects will be informed if their results are positive for hepatitis C, HIV 1 \& 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for follow up of these abnormal laboratory tests.)
• Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
• Health care workers.
• For women, 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).
• 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.
• Medical problems as a result of alcohol or illicit drug use during the past 12 months.
• 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.
• Receipt of any licensed vaccine within four weeks before enrolment in this study.
• Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
• Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
• 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.
• 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).
• Any history of hereditary angioedema or idiopathic angioedema.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead
• Indian Council of Medical Research: collaborator

Study Sites (12)

King George Hospital

Visakhapatnam, Andhra Pradesh, 560037, India

Location

All India Institute of Medical Sciences

Patna, Bihar, 801507, India

Location

Pt BD SHARMA,PGIMS/UHS

Rohtak, Haryana, 124001, India

Location

Jeevan Rekha Hospital

Belagavi, Karnataka, 590019, India

Location

Gillukar Multispeciality Hospital

Nagpur, Maharashtra, 440009, India

Location

All India Institute of Medical Sciences

Delhi, New Delhi, 110029, India

Location

Institute of Medical Sciences and SUM Hospital

Bhubaneswar, Odisha, 751003, India

Location

SRM Hospital & Research center

Chennai, Tamil Nadu, 603211, India

Location

Nizam's Institute of Medical Sciences

Hyderabad, Telangana, 500082, India

Location

Rana Hospital and Trauma Center

Gorakhpur, Uttar Pradesh, 273013, India

Location

Prakhar Hospital

Kanpur, Uttar Pradesh, 208002, India

Location

Redkar Hospital and Research Centre

Goa, 403513, India

Location

Related Publications (4)

• Vadrevu KM, Ganneru B, Reddy S, Jogdand H, Raju D, Sapkal G, Yadav P, Reddy P, Verma S, Singh C, Redkar SV, Gillurkar CS, Kushwaha JS, Mohapatra S, Bhate A, Rai SK, Ella R, Abraham P, Prasad S, Ella K. Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variants. Sci Rep. 2022 Jul 14;12(1):12038. doi: 10.1038/s41598-022-16097-3.

  PMID: 35835822 DERIVED

• Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, Das D, Raju D, Praturi U, Sapkal G, Yadav P, Reddy P, Verma S, Singh C, Redkar SV, Gillurkar CS, Kushwaha JS, Mohapatra S, Bhate A, Rai S, Panda S, Abraham P, Gupta N, Ella K, Bhargava B, Vadrevu KM. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial. Lancet Infect Dis. 2021 Jul;21(7):950-961. doi: 10.1016/S1473-3099(21)00070-0. Epub 2021 Mar 8.

  PMID: 33705727 DERIVED

• Yadav PD, Ella R, Kumar S, Patil DR, Mohandas S, Shete AM, Vadrevu KM, Bhati G, Sapkal G, Kaushal H, Patil S, Jain R, Deshpande G, Gupta N, Agarwal K, Gokhale M, Mathapati B, Metkari S, Mote C, Nyayanit D, Patil DY, Sai Prasad BS, Suryawanshi A, Kadam M, Kumar A, Daigude S, Gopale S, Majumdar T, Mali D, Sarkale P, Baradkar S, Gawande P, Joshi Y, Fulari S, Dighe H, Sharma S, Gunjikar R, Kumar A, Kalele K, Srinivas VK, Gangakhedkar RR, Ella KM, Abraham P, Panda S, Bhargava B. Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques. Nat Commun. 2021 Mar 2;12(1):1386. doi: 10.1038/s41467-021-21639-w.

  PMID: 33654090 DERIVED

• Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, Ganneru B, Sapkal G, Yadav P, Abraham P, Panda S, Gupta N, Reddy P, Verma S, Kumar Rai S, Singh C, Redkar SV, Gillurkar CS, Kushwaha JS, Mohapatra S, Rao V, Guleria R, Ella K, Bhargava B. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial. Lancet Infect Dis. 2021 May;21(5):637-646. doi: 10.1016/S1473-3099(20)30942-7. Epub 2021 Jan 21.

  PMID: 33485468 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Savita Verma, MBBS, MD

  PGIMS, Rohtak

  PRINCIPAL INVESTIGATOR

• Dr. Sanjay Kumar Rai, MBBS, MD

  All India Institute of Medical Sciences, Delhi

  PRINCIPAL INVESTIGATOR

• Dr. Chandramani Singh, MBBS, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Dr. Ajeeth Pratap Singh, MBBS, MD

  Rana Hospital and Trauma Centre, Gorakhpur

  PRINCIPAL INVESTIGATOR

• Dr. Satyajit Mohapatra, MBBS, MD

  SRM Hospital and Research Centre, Chennai

  PRINCIPAL INVESTIGATOR

• Dr. Prabhakar Reddy, MBBS, MD

  Nizams Institute of Medical Sciences, Hyderabad

  PRINCIPAL INVESTIGATOR

• Dr. Venkata Rao, MBBS, MD

  IMS & SUM Hospital, Orissa

  PRINCIPAL INVESTIGATOR

• Dr. Jitendra Kushwaha, MBBS, MD

  Prakhar Hospital, Kanpur

  PRINCIPAL INVESTIGATOR

• Dr. Sagar Vivek Redkar, MBBS, MD

  Redkar Hospital and Research Center, Goa

  PRINCIPAL INVESTIGATOR

• Dr. Amit Bhate, MBBS, MD

  Jeevan Rekha Hospital, Belguam

  PRINCIPAL INVESTIGATOR

• Dr. Chadrashekar Gillukar, MBBS, MD

  Gillukar Multispeciality Hospital, Nagpur

  PRINCIPAL INVESTIGATOR

• Dr Vasudev R, MBBS, MD

  King George Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2020
• First Posted: July 15, 2020
• Study Start: July 15, 2020
• Primary Completion: July 31, 2020
• Study Completion: June 30, 2021
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (12)