Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19

NCT04751682 | Completed Phase 1 DMC

• 1 other identifier: BBIL/BBV154/2020
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 4

Brief Summary

The study is designed to evaluate the safety, reactogenicity, and immunogenicity of three groups of healthy volunteers who receive either intranasal single dose (vaccine on Day 0 and placebo on Day 28) or two-dose (vaccine on Day 0 and 28) of BBV154 vaccine or Placebo (on Day 0 and day 28). A total of 175 subjects will be enrolled in 2:2:1 ratio and will be conducted in a double-blinded manner. To assess the safety of the vaccine, each participant will record symptoms in a diary card for 7 days after each dose. Safety and laboratory tests and physical exams will also be performed. Blood samples and saliva samples be collected to assess the immune response from the vaccine. An interim report based on the safety and immunogenicity of the vaccine (BBV154) will be notified to the Central Drugs Standard Control Organization (CDSCO), India, for further progressing the clinical development of the vaccine. This unblinded interim report will contain a detailed analysis of the data based on the primary and secondary objectives of all visits through Day 42 (Immunogenicity \& Safety).

Conditions

SARS-CoV Infection

Outcome Measures

Primary Outcomes (4)

• Incidence of immediate adverse events.

  within 2 hours post each vaccination

• The incidence of solicited local and systemic adverse events

  within 7 days post each vaccination

• The incidence of serious adverse events (SAEs)

  Through study completion, an average of 6 months

• The incidence of unsolicited adverse events

  Through study completion, an average of 6 months

Secondary Outcomes (7)

• To evaluate the humoral immune responses of BBV154

  Through study completion, an average of 6 months

• To compare the humoral responses between single dose group and double dose group.

  Through study completion, an average of 6 months

• To evaluate the immune responses against spike protein of SARS-CoV-2 virus and Adenovirus vector

  Through study completion, an average of 6 months

• Vaccine induced cell mediated antigen specific T-cell responses across the three groups.

  Through study completion, an average of 6 months

• Vaccine induced cell mediated antigen specific cytokines across the three groups. To evaluate the vaccine induced Cell mediated immune response.

  Through study completion, an average of 6 months

Study Arms (3)

BBV154: Single Dose

EXPERIMENTAL

Group 1 (Single dose group): In this group, 70 participants will be recruited and administered with vaccine (BBV154) on day 0 and with placebo on day 28 via intranasal route.

Biological: BBV154 Vaccine

BBV154: Two Dose

EXPERIMENTAL

Group 2 (Two-dose group): In this group, 70 participants will be recruited and administered with vaccine (BBV154) on both day 0 and on day 28 via intranasal route.

Biological: BBV154 Vaccine

Placebo

PLACEBO COMPARATOR

Group 3 (Placebo): In this group, 35 participants will be recruited and administered with placebo on both day 0 and day 28 via intranasal route.

Biological: Placebo

Interventions

BBV154 Vaccine BIOLOGICAL

Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) NLT 1X10\^10 Virus Particle.

BBV154: Single Dose; BBV154: Two Dose

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide written informed consent.
• Participants of either gender of age between ≥18 to ≤60 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 fulfil 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/or licensed 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 or CLIA method.
• History of facial nerve paralysis
• History of cold, sneezing, nasal obstruction in the past 3 days.
• Prescribed usage of any nasal spray/or nasal drop medication.
• Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded)
• 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).
• 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 enrolment 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (4)

AIIMS,Patna

Patna, Bihar, India

Location

Apollo Hospitals,Chennai

Chennai, Tamil Nadu, India

Location

St.Theresa Hospital, Hyderabad

Hyderabad, India

Location

Gillurkar Multispeciality Hospital,Nagpur

Nagpur, India

Location

Related Publications (1)

• Hassan AO, Kafai NM, Dmitriev IP, Fox JM, Smith BK, Harvey IB, Chen RE, Winkler ES, Wessel AW, Case JB, Kashentseva E, McCune BT, Bailey AL, Zhao H, VanBlargan LA, Dai YN, Ma M, Adams LJ, Shrihari S, Danis JE, Gralinski LE, Hou YJ, Schafer A, Kim AS, Keeler SP, Weiskopf D, Baric RS, Holtzman MJ, Fremont DH, Curiel DT, Diamond MS. A Single-Dose Intranasal ChAd Vaccine Protects Upper and Lower Respiratory Tracts against SARS-CoV-2. Cell. 2020 Oct 1;183(1):169-184.e13. doi: 10.1016/j.cell.2020.08.026. Epub 2020 Aug 19.

  PMID: 32931734 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

BBV152 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The vaccine and placebo are identical in appearance and colour.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: March 1, 2021
• Primary Completion: June 25, 2021
• Study Completion: November 30, 2021
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)