Zika Virus InfectionPhase 1ZikaNCT04478656
Safety and Immunogenicity of BBV121
A Phase 1 study testing BBV121 in people with Zika Virus Infection, run by Bharat Biotech International Limited at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus Infection
- What is being tested?
- BBV121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 3 Jun 2017to 15 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Signed written informed consent prior to inclusion in the 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
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- 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
- Platelets >100,000/mm3
- Bilirubin and AST/ ALT <1.5 x ULN (upper limit of normal)
- Creatinine <1.5 x ULN for the clinical laboratory
- Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
- Patients should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the clinical parameters including ECG and Chest X-ray.
- Willing to allow storage and future use of biological samples for Zika virus related research.
Who cannot join
- 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
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- 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
- Metal implants within 20 cm of the planned site(s) of injection
- Presence of keloid scar formation or hypertrophic scar at the planned site(s) of injection
- Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness
- Active addictive drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints
- Blood donations/ losses within 2 months of screening
- Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mmHg or more on standing)
- Prior radiotherapy in 30 days or less
- Significant pre-existing co-morbidities i. Cardiovascular
- Myocardial infarction within the last 6 months
- Congestive heart failure
- Unstable angina
- Active cardiomyopathy
- Cardiac arrhythmia
- Uncontrolled hypertension
- History of familial long QT syndrome or sudden cardiac death ii. Pulmonary disease requiring oxygen iii. Neurologic and psychiatric
- History of significant neurologic or psychiatric disorder that would preclude study compliance or ability to give informed consent iv. Rheumatic arthralgia
- Participants not having adequate hematologic reserve i. Hemoglobin <10gm/dL ii. WBC (white blood cells) <4000/mm3 iii. ANC (absolute neutrophils count) <2000/ mm3 iv. Platelets <100,000/mm3
- Inadequate hepatic function at screening as defined by:
- Bilirubin >1.5 x ULN (upper limit of normal) ii. AST/ ALT >1.5 x ULN
- Inadequate renal function at screening as defined by:
- Creatinine >1.5 x ULN for the clinical laboratory
- An unusual or abnormal diet, for whatever reason e.g. religious fasting
- Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial to Evaluate 2 Doses of 3 Sequentially Escalating Cohort of BBV121 in Healthy Adult Dengue Sero-Negative and Dengue Sero-Positive Volunteers
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
Read the detailed description
A phase 1, multicenter, double-blind, placebo-controlled, randomised (intra group) clinical trial 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 (inactivated adsorbed Zika Virus Vaccine) compared with Placebo (Alum) administered intramuscularly on Day 0 and 28 in healthy adult Dengue Sero-Negative (Group 1) and Dengue Sero-Positive (Group 2) male and female volunteers.
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.
Immunogenicity testing on Day 0, 28 and 56, and post-study at the end of Month 6, 9 and 12 after the initial administration of the investigational product.
Safety tests (laboratory and clinical investigations) will be done during Screening, Day 0, 28, 56, and post-study at Month 6, 9 and 12 months after the initial administration of the investigational product.
- Conditions
- Zika Virus Infection
- Being tested
- BBV121
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBV121Biological
Also called Placebo
BBV121 or Placebo are administered intramuscularly in deltoid region on Day 0 and 28
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: BBV121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events and Serious Adverse events
safety
- Incidence of solicited AEs post-vaccination
- Incidence of unsolicited AEs post-vaccination
- Incidence of SAE
Measured: Within 2 hrs
Occurrence of adverse events and Serious Adverse events
safety
Measured: 7 Days
Occurrence of adverse events and Serious Adverse events
safety
Measured: 12 months
Secondary outcomes (4)
Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion
Immunogenicity
Measured: Day 0
Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion
Immunogenicity
Measured: Day 28
Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion
Immunogenicity
Measured: Day 56
Geometric mean titre estimated by 50% plaque reduction neutralization test
Immunogenicity
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start3 Jun 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zika Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudhakar Bangera, Study chair, Bharat Biotech International Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478656
- Sponsor's protocol ID
- BBIL/ZIKV/I/2016
- Acronym
- Zika
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial to Evaluate 2 Doses of 3 Sequentially Escalating Cohort of BBV121 in Healthy Adult Dengue Sero-Negative and Dengue Sero-Positive Volunteers
- ClinicalTrials.gov ID
- NCT04478656
- Acronym / sponsor ID
- Zika / BBIL/ZIKV/I/2016
- Conditions
- Zika Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A phase 1, multicenter, double-blind, placebo-controlled, randomised (intra group) clinical trial 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 (inactivated adsorbed Zika Virus Vaccine) compared with Placebo (Alum) administered intramuscularly on Day 0 and 28 in healthy adult Dengue Sero-Negative (Group 1) and Dengue Sero-Positive (Group 2) male and female volunteers.
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.
Immunogenicity testing on Day 0, 28 and 56, and post-study at the end of Month 6, 9 and 12 after the initial administration of the investigational product.
Safety tests (laboratory and clinical investigations) will be done during Screening, Day 0, 28, 56, and post-study at Month 6, 9 and 12 months after the initial administration of the investigational product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BBV121-2.5 µg | Experimental | Biological: BBV121BBV121: Each 0.5ml vial contain purified10 µg inactivated Zika virus, alum, 2-PE and phosphate buffered saline qs to 0.5mL |
| Placebo | Placebo comparator | Biological: BBV121Each 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 |
| BBV121-5 µg | Experimental | Biological: BBV121BBV121: Each 0.5ml vial contain purified inactivated Zika virus, alum, 2-PE and phosphate buffered saline qs to 0.5mL |
| BBV121-10 µg | Experimental | Biological: BBV121BBV121: Each 0.5ml vial contain purified inactivated Zika virus, alum, 2-PE and phosphate buffered saline qs to 0.5ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
- Signed written informed consent prior to inclusion in the 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBV121Also: PlaceboBBV121 or Placebo are administered intramuscularly in deltoid region on Day 0 and 28 | Biological | BBV121-10 µg, BBV121-2.5 µg, BBV121-5 µg, Placebo |
Primary outcome
Occurrence of adverse events and Serious Adverse events
Time frame: Within 2 hrs
safety * Incidence of solicited AEs post-vaccination * Incidence of unsolicited AEs post-vaccination * Incidence of SAE
Occurrence of adverse events and Serious Adverse events
Time frame: 7 Days
safety
Occurrence of adverse events and Serious Adverse events
Time frame: 12 months
safety
4 secondary outcomes
Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion
Time frame: Day 0
Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion
Time frame: Day 28
Geometric mean titre estimated by 50% plaque reduction neutralization test and four-fold seroconversion
Time frame: Day 56
Geometric mean titre estimated by 50% plaque reduction neutralization test
Time frame: Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudhakar Bangera study chair
Bharat Biotech International Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBV121 in people with Zika Virus Infection, run by Bharat Biotech International Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events and Serious Adverse events (time frame: Within 2 hrs). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020; AzTrials last refreshed its copy on 3 Nov 2026.