SARS-CoV InfectionPhase 1NCT04751682
Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19
A Phase 1 study testing BBV154 Vaccine in people with SARS-CoV Infection, run by Bharat Biotech International Limited at 4 sites in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- BBV154 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 4 sitesIndia
- Study dates
- 1 Mar 2021to 30 Nov 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 33Show fewer
- 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.
- 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.
- Any history of anaphylaxis in relation to vaccination.
- Any history of albumin-intolerance.
- Pregnancy, lactation, or willingness/intention to become pregnant during the study.
- History of any cancer.
- History of severe psychiatric conditions likely to affect participation in the study.
- A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
- Any other serious chronic illness requiring hospital specialist supervision.
- Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
- Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
- Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
- Living in the same household of any COVID-19 positive person.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. Re-Vaccination Exclusion Criteri.
- Pregnancy.
- Anaphylactic reaction following administration of the investigational vaccine.
- Virologically confirmed cases of SARS-CoV-2 infection.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Apollo Hospitals,Chennai
Chennai, Tamil Nadu
St.Theresa Hospital, Hyderabad
Hyderabad
Gillurkar Multispeciality Hospital,Nagpur
Nagpur
AIIMS,Patna
Patna, Bihar
About this study
Official title: A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenovirus Vector COVID-19 Vaccine (BBV154) in Healthy Volunteers
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.
Read more
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
- Being tested
- BBV154 Vaccine, Placebo
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBV154 VaccineBiological
Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) NLT 1X10^10 Virus Particle.
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immediate adverse events.
Measured: within 2 hours post each vaccination
The incidence of solicited local and systemic adverse events
Measured: within 7 days post each vaccination
The incidence of serious adverse events (SAEs)
Measured: Through study completion, an average of 6 months
The incidence of unsolicited adverse events
Measured: Through study completion, an average of 6 months
Secondary outcomes (7)
To evaluate the humoral immune responses of BBV154
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the three groups.
Measured: Through study completion, an average of 6 months
To compare the humoral responses between single dose group and double dose group.
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the three groups.
Measured: Through study completion, an average of 6 months
To evaluate the immune responses against spike protein of SARS-CoV-2 virus and Adenovirus vector
GMT and four-fold seroconversion rate of binding antibodies (bAb's) IgA and IgG against spike protein across the three groups.
Immune response (binding/ or neutralization) to the vector will be assessed by ELISA
Measured: Through study completion, an average of 6 months
Vaccine induced cell mediated antigen specific T-cell responses across the three groups.
IFN-gamma (ELISPOT)
Measured: 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.
Th1/Th2 profiling
Measured: Through study completion, an average of 6 months
To evaluate the vaccine secretory IgA antibody response.
Measured: Through study completion, an average of 6 months
To evaluate the safety of the vaccine in terms of assessing adverse event of special interest (AESI)
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Mar 2021
- Primary completion25 Jun 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 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
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751682
- Sponsor's protocol ID
- BBIL/BBV154/2020
- Status last verified
- Aug 2022
- First submitted
- 8 Feb 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32931734
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenovirus Vector COVID-19 Vaccine (BBV154) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04751682
- Acronym / sponsor ID
- BBIL/BBV154/2020
- Conditions
- SARS-CoV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 12 Feb 2021 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BBV154: Single Dose | Experimental | Biological: BBV154 VaccineGroup 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. |
| BBV154: Two Dose | Experimental | Biological: BBV154 VaccineGroup 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. |
| Placebo | Placebo comparator | Biological: PlaceboGroup 3 (Placebo): In this group, 35 participants will be recruited and administered with placebo on both day 0 and day 28 via intranasal route. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (33 listed)
- 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
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 |
|---|---|---|
| BBV154 VaccineReplication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) NLT 1X10^10 Virus Particle. | Biological | BBV154: Single Dose, BBV154: Two Dose |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Incidence of immediate adverse events.
Time frame: within 2 hours post each vaccination
The incidence of solicited local and systemic adverse events
Time frame: within 7 days post each vaccination
The incidence of serious adverse events (SAEs)
Time frame: Through study completion, an average of 6 months
The incidence of unsolicited adverse events
Time frame: Through study completion, an average of 6 months
7 secondary outcomes
To evaluate the humoral immune responses of BBV154
Time frame: Through study completion, an average of 6 months
To compare the humoral responses between single dose group and double dose group.
Time frame: Through study completion, an average of 6 months
To evaluate the immune responses against spike protein of SARS-CoV-2 virus and Adenovirus vector
Time frame: Through study completion, an average of 6 months
Vaccine induced cell mediated antigen specific T-cell responses across the three groups.
Time frame: 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.
Time frame: Through study completion, an average of 6 months
To evaluate the vaccine secretory IgA antibody response.
Time frame: Through study completion, an average of 6 months
To evaluate the safety of the vaccine in terms of assessing adverse event of special interest (AESI)
Time frame: Through study completion, an average of 6 months
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 18 Aug 2022.
- Background: PubMed 32931734Hassan 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.
- Individual participant dataSharing planned: No
Related trials for SARS-CoV Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
SARS-CoV Infection
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBV154 Vaccine in people with SARS-CoV Infection, run by Bharat Biotech International Limited at 4 sites 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 11 inclusion and 33 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Incidence of immediate adverse events. (time frame: within 2 hours post each vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751682, which also lists 1 linked publication.
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 18 Aug 2022.