Safety and Immunogenicity of BBV121

NCT04478656 | Completed Phase 1 DMC

• 1 other identifier: BBIL/ZIKV/I/2016
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, and immunogenicity of two-doses of three-sequentially escalating cohort (2.5 µg, 5 µg and 10 µg) of BBV121 (purified inactivated adsorbed Zika virus vaccine) compared with Placebo (Alum). The investigational product is administered intramuscularly on Day 0 and 28 with safety and immunogenicity testing on Day 0, 28 and 56, and Month 6, 9 and 12

Conditions

Zika Virus Infection

Outcome Measures

Primary Outcomes (3)

• Occurrence of adverse events and Serious Adverse events

  safety * Incidence of solicited AEs post-vaccination * Incidence of unsolicited AEs post-vaccination * Incidence of SAE

  Within 2 hrs

• Occurrence of adverse events and Serious Adverse events

  safety

  7 Days

• Occurrence of adverse events and Serious Adverse events

  safety

  12 months

Secondary Outcomes (4)

• Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion

  Day 0

• Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion

  Day 28

• Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion

  Day 56

• Geometric mean titre estimated by 50% plaque reduction neutralization test

  Day 365

Study Arms (4)

BBV121-2.5 µg

EXPERIMENTAL

BBV121: Each 0.5ml vial contain purified10 µg inactivated Zika virus, alum, 2-PE and phosphate buffered saline qs to 0.5mL

Biological: BBV121

Placebo

PLACEBO COMPARATOR

Each 0.5ml vial contain purified 2.5 µg, 5 µg or 10 µg inactivated Zika virus, alum, 2-PE and phosphate buffered saline qs to 0.5mL

Biological: BBV121

BBV121-5 µg

EXPERIMENTAL

BBV121: Each 0.5ml vial contain purified inactivated Zika virus, alum, 2-PE and phosphate buffered saline qs to 0.5mL

Biological: BBV121

BBV121-10 µg

EXPERIMENTAL

BBV121: Each 0.5ml vial contain purified inactivated Zika virus, alum, 2-PE and phosphate buffered saline qs to 0.5ml

Biological: BBV121

Interventions

BBV121 BIOLOGICAL

BBV121 or Placebo are administered intramuscularly in deltoid region on Day 0 and 28

Also known as: Placebo

BBV121-10 µg; BBV121-2.5 µg; BBV121-5 µg; Placebo

Eligibility Criteria

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

You may qualify if:

• Normal healthy male and female volunteers aged between 18 and 65 years weighing at least 50kgs of body weight
• Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study
• Seronegative for Zika by ELISA
• Dengue sero-negative at baseline by screening laboratory evaluation, confirmed by Dengue IgG by ELISA method for Group 1 participants
• Dengue seropositive at baseline by screening laboratory evaluation, confirmed by Dengue IgG by ELISA method for Group 2 participants
• Dengue vaccination or suffered from Dengue viral fever for Group 2 volunteers
• No history of yellow fever vaccination
• No history of vaccination to Japanese encephalitis vaccination
• Since active (live) ZIKV infection is known to cause teratogenicity, women of child-bearing potential should agree to use medically effective contraception (oral contraception, barrier methods, spermicide, etc.), preferably double contraception or have a partner who is sterile from enrollment to 3 months following the last injection, or have a male partner who is medically unable to induce pregnancy.
• Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception, preferably double contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or is medically unable to become pregnant.
• A negative urine or serum pregnancy test before administration of investigational vaccine on day of screening (Serum Pregnancy Test), and Day 0 and Day 28 (both days Urine Pregnancy Test)
• No history of clinically significant immunosuppressive or autoimmune disease.
• Laboratory investigations must be within normal limits
• Hemoglobin \>10gm/dL
• WBC (white blood cells) \>4000/mm3

You may not qualify if:

• Administration of an investigational vaccine or drug either currently or within 30 days of first BBV121 vaccination
• Previous receipt of an investigational vaccine or drug for the treatment or prevention of Zika virus
• Administration of any vaccine within 4 weeks of first dose
• Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose of BBV121 vaccination
• Administration of any blood product within 3 months of first dose
• Pregnancy or breast feeding or plans to become pregnant during the study
• Positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor
• Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
• Chronic liver disease or cirrhosis
• Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation
• Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day)
• Current or anticipated treatment with TNF-alpha inhibitors such as infliximab, adalimumab, and etanercept
• Prior major surgery or any radiation therapy within 4 weeks of enrolment
• Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome
• Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (1)

Bharat Biotech International Ltd

Hyderabad, Telangana, 500078, India

Location

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Sudhakar Bangera

  Bharat Biotech International Limited

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinded vial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to sequential escalating dose level groups to receive vaccinations at 2.5 µg, 5 µg, or 10 µg or Placebo on Day 0 and 28 with follow-up for 12 months from initial administration of the investigational product.

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2020
• Study Start: June 3, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2018
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)