An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers

NCT04641481 | Unknown Phase 3 DMC

• 1 other identifier: BBIL/BBV152-C/2020
• Study Type: interventional
• Target: 25,800
• Locations: 1 country
• Sites: 1

Brief Summary

The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.

Conditions

Covid19; SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19.

  (RT-PCR positive) symptomatic cases of COVID-19.

  Day 42 to Month 12

Secondary Outcomes (8)

• First occurence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19 based on the case definition for the secondary efficacy symptomatic endpoint.

  Day 42 to Month 12

• Virologically confirmed (RT-PCR positive) severe cases of COVID-19

  Day 42 to Month 12

• Virologically confirmed COVID-19 cases of any severity occurring among participants 18 through 59 years of age and ≥60 years of age.

  Day 42 to Month 12

• Virologically confirmed COVID-19 asymptomatic and symptomatic cases occurring from two weeks after the second vaccination.

  Day 42 to Month 12

• Reactogenicity and Safety

  Day 42 to Month 12

Study Arms (2)

Study vaccine

EXPERIMENTAL

BBV152B (6µg-Algel-IMDG)

Biological: BBV152

Placebo

PLACEBO COMPARATOR

Phosphate buffered saline with Alum (without antigen)

Biological: Placebo

Interventions

BBV152 BIOLOGICAL

BBV152 (6µg-Algel - Imidazoquinoline)

Study vaccine

Placebo BIOLOGICAL

Placebo (PBS+Alum, without antigen)

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and availability to fulfill the study requirements.
• Participants of either gender of aged 18 years and above.
• Participants with good general health as determined by the discretion of the investigator, or participants with stable medical conditions. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization or worsening disease during the 3 months before enrolment.
• 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 eight weeks after the last vaccination.
• Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination.
• Agrees not to participate in another clinical trial at any time during the study period.
• Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study.
• 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 or licensed vaccination.
• Known history of SARS-CoV-2 infection, as declared by the subject.
• For women, positive urine pregnancy test before the first dose of vaccination, or any time during the study period.
• 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.
• Resident of COVID-19 infection in the same household.
• Known case of HIV, hepatitis B, or hepatitis C infection.
• Receipt of any licensed/experimental vaccine within four weeks before enrolment in this study.
• Receipt of immunoglobulin or other blood products within the three months before 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.
• Immunoglobulins, anti-cytokine antibodies, and blood products within 6 months prior to study vaccination, during, and 21 days following the last dose of vaccination.
• Pregnancy, lactation, or willingness/intention to become pregnant during the first 6 months after enrolment.
• Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and neurological illness (mild/moderate well-controlled comorbidities are allowed)
• Pregnancy.
• History of virologically (RT-PCR) confirmed SARS-CoV-2 infection
• Anaphylactic reaction following administration of the investigational vaccine.

Sponsors & Collaborators

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

Study Sites (1)

Pt BD SHARMA,PGIMS/UHS

Rohtak, Haryana, 124001, India

Location

Related Publications (1)

• Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, Aileni VK, Kanungo S, Rai S, Reddy P, Verma S, Singh C, Redkar S, Mohapatra S, Pandey A, Ranganadin P, Gumashta R, Multani M, Mohammad S, Bhatt P, Kumari L, Sapkal G, Gupta N, Abraham P, Panda S, Prasad S, Bhargava B, Ella K, Vadrevu KM; COVAXIN Study Group. Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial. Lancet. 2021 Dec 11;398(10317):2173-2184. doi: 10.1016/S0140-6736(21)02000-6. Epub 2021 Nov 11.

  PMID: 34774196 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

BBV152 COVID-19 vaccine

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 Chadramani Singh

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Dr Sanjay Kumar Rai

  All India Institute of Medical Sciences Delhi

  PRINCIPAL INVESTIGATOR

• Dr Azhar Ali Khan

  Baba Raghav Das Medical Gorakhpur

  PRINCIPAL INVESTIGATOR

• DrAnil Kumar Pandey

  ESIC Medical College and Hospital Faridabad

  PRINCIPAL INVESTIGATOR

• Dr Simmi Dube

  Gandhi Medical College, Bhopal

  PRINCIPAL INVESTIGATOR

• Dr Anjan Jyoti Talukdar

  Gauhati Medical College & Hospital Assam

  PRINCIPAL INVESTIGATOR

• Dr Priti Meshram

  Grant Government Medical College and Sir J.J. Group of Hospitals Mumbai

  PRINCIPAL INVESTIGATOR

• Dr Laxmi S Kumari

  Guntur Medical College ,Guntur

  PRINCIPAL INVESTIGATOR

• Dr Shiva Narang

  Guru Teg Bahadur Hospital

  PRINCIPAL INVESTIGATOR

• Dr E Venkat Rao

  Institute of Medical Sciences and SUM Hospital Odisha

  PRINCIPAL INVESTIGATOR

• Dr P Venugopal

  King George Hospital Visakhapatnam

  PRINCIPAL INVESTIGATOR

• Dr. N.T. Awad

  Lokamanya tilak Municipal Medical College and General hospital Mumbai

  PRINCIPAL INVESTIGATOR

• Dr Pajanivel Ranganadin

  Mahatma Gandhi Medical College& Research Institute Pondicherry

  PRINCIPAL INVESTIGATOR

• Dr Prabhakar Reddy

  Nizam's Institute of Medical Sciences Hyderabad

  PRINCIPAL INVESTIGATOR

• Dr Raghavendra Gumashta

  Peoples university Bhopal

  PRINCIPAL INVESTIGATOR

• Dr Tapan Kumar Saikia

  Prince Aly Khan Hospital Mumbai

  PRINCIPAL INVESTIGATOR

• Dr Savita Verma

  Pt BO Sharma,PGIMS/UHS. Rohtak, Haryana

  PRINCIPAL INVESTIGATOR

• Dr Manish Multani

  Rahate Surgical Hospital ,Nagpur

  PRINCIPAL INVESTIGATOR

• Dr Sagar Vivek Redkar

  Redkar Hospital and Research Centre Goa

  PRINCIPAL INVESTIGATOR

• Dr Meghana Murthy

  Vagus Super speciality hospital,Bangalore

  PRINCIPAL INVESTIGATOR

• Dr Akshata

  Vydehi Institute of Medical Sciences and Research Centre,Bangalore

  PRINCIPAL INVESTIGATOR

• Dr T S Selvavinayagam

  Directorate of Public Health and Preventive Medicine,Chennai

  PRINCIPAL INVESTIGATOR

• Dr Suman Kanungo

  ICMR-National Institute of Cholera and Enteric Diseases,West Bengal

  PRINCIPAL INVESTIGATOR

• Dr Mohammad Shameem

  Aligarh Muslim University,Uttar Pradesh

  PRINCIPAL INVESTIGATOR

• Dr Parul Bhatt

  Gmers Medical College and Civil Hospital,Ahmedabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All vaccine and placebo formulations are at a volume of 0.5mL per dose filled into a single-use glass vial. The appearance, color, and viscosity are identical across all vaccine and control formulations. Participants, investigators, study coordinators, study-related personnel, and the sponsor will be blinded to the treatment group allocation (excluding an unblinded CRO, who is tasked with the dispatch and labeling of vaccine vials and the generation of the master randomization code). Participants will be assigned a computer-generated randomization code that maintains blinding. The blinded study nurse is responsible for vaccine preparation and administration. Each vial contains a unique code that ensured appropriate blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 23, 2020
• Study Start: November 16, 2020
• Primary Completion: January 8, 2021
• Study Completion: December 1, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)