COVID-19 Respiratory InfectionPhase 3NCT05567471
Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose
A Phase 3 study testing BBV154 Intranasal Vaccine, Intramuscular vaccine COVAXIN and Covishield in people with COVID-19 Respiratory Infection, run by Bharat Biotech International Limited at 9 sites in India.
Trial summary
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1. Group 1: (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- BBV154 Intranasal Vaccine, Intramuscular vaccine COVAXIN and Covishield
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 875 participants
- Where
- 9 sitesIndia
- Study dates
- 26 Feb 2022to 28 Sep 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent.
- Participants of either gender of age ≥18 years.
- Received and completed COVID-19 vaccine under Emergency Use Authorization (EUA) dosing guidelines at least 6 ± 1 month (after receipt of second dose of EUA vaccine) prior to enrollment, confirmed by the electronic Covid-19 Certificate (CoWIN).
- Expressed interest and availability to fulfill 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 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
- Known history of COVID-19 infection.
- 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 of vaccine).
- Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness such as an upper respiratory infection or gastroenteritis within three days prior to vaccination.
- Medical problems because 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.
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- 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 because 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 anaphylaxis in relation to vaccination.
- 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 immediate hospital specialist supervision.
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Vagus Super Specilaity Hospitals
Bangalore, Karnataka, 560003
Jeevan Rekha Hospital
Belagavi, Karnataka, 590002
ESIC Medical College and Hospital
Faridabad, Haryana, 121001
Rana Hospital Pvt Ltd
Gorakhpur, Uttar Pradesh, 273001
St. Theresa Hospital
Hyderabad, Telangana, 500018
Prakhar Hospital Pvt Ltd
Kanpur, Uttar Pradesh, 208002
Gillurkar Multispeciality Hopistal
Nagpur, Maharashtra, 440009
AIIMS, New Delhi
New Delhi, 110029
All India Institute of Medical Sciences
Patna, Bihar, 801507
About this study
Official title: Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated With EUA Vaccines
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.
Group 1: (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.
Read more
Group 2: (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Group 3: (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.
Group 4: (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.
Group 5: (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
Read the detailed description
Sample Collection:
- Pregnancy test will be conducted by using rapid test kit throughout the study.
- Immunogenicity analysis: A total of 5 ml of blood is collected at days 0, 28, 56 (Subset n=150 each in Groups 1 \&3 and 75 each in Groups 2, 4, and 5). Sera will collect from the blood sample and stored as 3 aliquots at -20°C.
- An additional blood sample (10 mL) will be collected for assessment of cell mediated responses on days 0, 28, 56 (Subset n=40each in Groups 1 \& 3 and 20 each in Groups 2, 4, and 5).
- A saliva sample (5 mL) will be collected on days 0, 28, 56 (Same subset as for assessment of cell mediated responses). Saliva will be collected by Passive drool method using Falcon tube.
Sample Size:
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study
Randomization:
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.
Block randomization with an integrated web response will be utilized to ensure balance among the four groups, with a 2:1:2:1:1 ratio allocation of Group 1, 2, 3, 4 and 5 respectively.
STUDY RATIONALE:
The reasons for booster doses may differ by population groups at risk, type of vaccine, waning immunity, variants of concern, and clinical and epidemiological settings (1). Studies have shown that immunity after vaccination against SARS-CoV-2 infection wanes in a few months of time, which suggests the need for a booster dose. The emergence of SARS-CoV-2 variants due to multiple mutations in the Spike protein, such as Delta (B.1.617.2) variant in India and Beta strain (B.1.351) in South Africa have raised concerns because of their increased transmission rates.
As and when other variants emerge that are going to be worse than the present Covid-19 variants and has the potency to evade the currently available vaccines, then the requirement of booster shots would be needed. The most recent data from Israel and the United States in the context of the delta Variant of Concern (VOC) predominant circulation suggest that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose . Emory University, USA has been published the data that shown a 7 fold reduction in the antibody titer against SARS-CoV-2 virus in a span of 6 months post-vaccination with mRNA vaccine . The CDC, USA recommended the booster dose the individuals who are moderately to severely immunocompromised and not able to build enough protection in the first vaccination .
Globally, many countries like Israel, the UAE, Russia, France, Germany and Italy have already rolled out boosters. In Israel, where the country began offering boosters to people over 60 in July, early data suggests that a Pfizer booster dose can significantly improve immunity among people in that age group. The booster dose, the data indicated, reduced risk of infection in people 60 and were about 19.5 times less likely to have severe COVID-19 than were people in the same age group who had received only two jabs and were studied during a similar time period .
Study Design:
The Phase-III study is designed to evaluate the immunogenicity and safety of volunteers who receive either BBV154 vaccine via intranasal route or BBV152 vaccine via intramuscular route or COVISHIELD via intramuscular route when administered as booster dose in individuals previously vaccinated with EUA vaccines in India .A total of 875 participants will be enrolled, randomized and will be conducted in open labeled manner.
Group 1 (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.
Group 2 (BBV152 in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Group 3 (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine via intranasal route, in individuals previously vaccinated with COVISHIELD.
Group 4 (BBV152 in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVISHIELD.
Group 5 (COVISHIELD in COVISHIELD recipients) ) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
In addition to administering the vaccine, a series of blood samples (Immunogenicity Subset) will be collected for analyzing serum for immunological assessments.
A subset of 150 participants each in Groups 1 \&3 and 75 participants each in Groups 2, 4, and 5 will be assessed for immunogenicity. Among this subset an additional 10 mL blood and 5 mL of saliva will be collected from 40 participants each in Groups 1 \&3 and 20 participants each in Groups 2, 4, and 5 to assess the cell-mediated immune response and mucosal immunity, respectively.
STUDY PROCEDURES:-
Visit 1: Baseline (Day 0):
- The participant will be screened for eligibility based on medical history, vitals, and physical examination.
- If the participant is eligible (in good general health or stable pre-existing disease as per the discretion of the Principal investigator), a blood sample will be withdrawn prior to vaccination for all the participants.
- Blood sample (5 mL) will be collected from the subset of participants (n=150 each in Groups 1 \&3 and n=75 each in Groups 2, 4, and 5).
- 5 mL saliva and additional blood sample (10 mL for PBMC) will be collected to assess the secretary IgA Ab titer and cell mediated immune response in subset (n=40 in groups 1\&3 and n=20 in groups2,4,5).
- A study vaccine will be administered. Following vaccination, participants will remain at the study site for at least 30 minutes of observation to record any immediate adverse event.
- Diary card will be distributed to the participants.
- Telephonic follow-up at 15 ± 2 days intervals for assessing health status, and general and COVID-19 symptoms history.
Visit 2 (Day 28 + 2 days):
- Study participants will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- For the humoral immunogenicity subset, 5mL of blood will be collected and processed for serum for assessing neutralizing responses (150 each in Groups 1 \&3 and n=75 each in Groups 2, 4, and 5).
- 5 mL saliva and additional blood sample (10 mL for PBMC) will be collected to assess the secretary IgA Ab titer and cell mediated immune response in subset (n=40 in groups 1\&3 and n=20 in groups2,4,5)
- Telephonic follow-up for all the other participants at 15±2 days intervals for assessing health status, and general and COVID-19 symptoms history.
Visit 3 (Day 56 ± 7 days):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- For the humoral immunogenicity subset, 5mL of blood will be collected and processed for serum for assessing neutralizing responses (150 each in Groups 1 \&3 and n=75 each in Groups 2, 4, and 5).
- 5 mL saliva and additional blood sample (10 mL for PBMC) will be collected to assess the secretary IgA Ab titer and cell mediated immune response in subset (n=40 in groups 1\&3 and n=20 in groups2,4,5)
- Telephonic follow-up for all the other participants at 15±2 days intervals for assessing health status, and general and COVID-19 symptoms history.
Visit 4 (Day 90± 7 days):
Telephonic follow-up for all the other participants for assessing health status, and general and COVID-19 symptoms history.
Visit 5 (Day 180 ± 7 days):
Telephonic follow-up for all the other participants for assessing health status, and general and COVID-19 symptoms history
Safety Monitoring:
Subjects will be observed for 30 minutes after vaccination for immediate adverse events. Active surveillance will be conducted for all participants for seven days after vaccination to ascertain information on solicited adverse events ("Reactogenicity").
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- BBV154 Intranasal Vaccine, Intramuscular vaccine COVAXIN, Covishield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBV154 Intranasal VaccineBiological
Administered BBV154 vaccine in form of drops (0.5 mL) via intranasal route
Intramuscular vaccine COVAXINBiological
Administered BBV152 vaccine via intramuscular route
CovishieldBiological
Administered vaccine via intramuscular route
| Study group | Role | What they receive |
|---|---|---|
| Group 1(BBV154 in COVAXIN recipients) | Active comparator | 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN. Receives: Biological: BBV154 Intranasal Vaccine |
| Group 2 (COVAXIN in COVAXIN recipients) | Active comparator | 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN. Receives: Biological: Intramuscular vaccine COVAXIN |
| Group 3 (BBV154 in COVISHIELD recipients) | Active comparator | 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD. Receives: Biological: BBV154 Intranasal Vaccine |
| Group 4(COVAXIN in COVISHIELD recipients) | Active comparator | 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD. Receives: Biological: Intramuscular vaccine COVAXIN |
| Group 5 (COVISHIELD in COVISHIELD recipients) | Active comparator | 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD. Receives: Biological: Covishield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titres 1
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Measured: baseline
Geometric mean titres 2
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Measured: Day 28+2
Geometric mean titres 3
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Measured: Day 56 ± 7
Secondary outcomes (9)
Geometric mean titres 4
GMTs of serum IgG Abs by ELISA
Measured: Day 28+2
Geometric mean titres 5
GMTs of serum IgA Abs by ELISA
Measured: Day 56 ± 7
Cell mediated immune response
Vaccine induced T cell responses through cell mediated immune analysis
Measured: Day 28+2
Cell mediated immune response
Vaccine induced B cell responses through cell mediated immune analysis
Measured: Day 56 ± 7
Geometric mean titres
GMTs of secretary IgA Abs by ELISA.
Measured: Day 28+2
Geometric mean titres (GMTs)
GMTs of secretary IgA Abs by ELISA.
Measured: Day 56 ± 7
adverse events reported
The occurrence of solicited adverse events
Measured: 7 days after vaccination
adverse events of special interest reported
The occurrence of adverse event of special interest (AESI).
Measured: throughout the study duration 7 months
vaccine induced thrombosis and thrombocytopenia
The occurrence of the vaccine induced thrombosis and thrombocytopenia in participants reporting the respective symptoms and signs.
Measured: throughout the study duration 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start26 Feb 2022
- Primary completion3 May 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 875 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Sanjay Rai, MBBS,MD, Principal investigator, All India Institute of Medical SciencesDr Chandramani Singh, MBBS,MD, Principal investigator, All India Institute of Medical SciencesDr Anil Kumar Pandey, MBBS,MD, Principal investigator, ESIC Medical College and Hospital FaridabadDr Chandrashekhar S Gillurkar, MBBS,MD, Principal investigator, Gillurkar Multispeciality HopistalDr Amit Suresh Bhate, MBBS,MD, Principal investigator, Jeevan Rekha HospitalDr Jitendra Singh Kushwaha, MBBS,MD, Principal investigator, Prakhar Hospital Pvt LtdDr Shivaraj K K, MBBS,MD, Principal investigator, Vagus Super Specilaity HospitalsDr A Venkateshwar Rao, MBBS,MD, Principal investigator, St. Theresa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567471
- Sponsor's protocol ID
- BBIL/Booster/2021 Hetero
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated With EUA Vaccines
- ClinicalTrials.gov ID
- NCT05567471
- Acronym / sponsor ID
- BBIL/Booster/2021 Hetero
- Conditions
- COVID-19 Respiratory Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 875 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 5 Oct 2022 (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.
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.
Group 1: (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.
Group 2: (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Group 3: (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.
Group 4: (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.
Group 5: (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
Detailed description
Sample Collection:
- Pregnancy test will be conducted by using rapid test kit throughout the study.
- Immunogenicity analysis: A total of 5 ml of blood is collected at days 0, 28, 56 (Subset n=150 each in Groups 1 \&3 and 75 each in Groups 2, 4, and 5). Sera will collect from the blood sample and stored as 3 aliquots at -20°C.
- An additional blood sample (10 mL) will be collected for assessment of cell mediated responses on days 0, 28, 56 (Subset n=40each in Groups 1 \& 3 and 20 each in Groups 2, 4, and 5).
- A saliva sample (5 mL) will be collected on days 0, 28, 56 (Same subset as for assessment of cell mediated responses). Saliva will be collected by Passive drool method using Falcon tube.
Sample Size:
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study
Randomization:
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.
Block randomization with an integrated web response will be utilized to ensure balance among the four groups, with a 2:1:2:1:1 ratio allocation of Group 1, 2, 3, 4 and 5 respectively.
STUDY RATIONALE:
The reasons for booster doses may differ by population groups at risk, type of vaccine, waning immunity, variants of concern, and clinical and epidemiological settings (1). Studies have shown that immunity after vaccination against SARS-CoV-2 infection wanes in a few months of time, which suggests the need for a booster dose. The emergence of SARS-CoV-2 variants due to multiple mutations in the Spike protein, such as Delta (B.1.617.2) variant in India and Beta strain (B.1.351) in South Africa have raised concerns because of their increased transmission rates.
As and when other variants emerge that are going to be worse than the present Covid-19 variants and has the potency to evade the currently available vaccines, then the requirement of booster shots would be needed. The most recent data from Israel and the United States in the context of the delta Variant of Concern (VOC) predominant circulation suggest that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose . Emory University, USA has been published the data that shown a 7 fold reduction in the antibody titer against SARS-CoV-2 virus in a span of 6 months post-vaccination with mRNA vaccine . The CDC, USA recommended the booster dose the individuals who are moderately to severely immunocompromised and not able to build enough protection in the first vaccination .
Globally, many countries like Israel, the UAE, Russia, France, Germany and Italy have already rolled out boosters. In Israel, where the country began offering boosters to people over 60 in July, early data suggests that a Pfizer booster dose can significantly improve immunity among people in that age group. The booster dose, the data indicated, reduced risk of infection in people 60 and were about 19.5 times less likely to have severe COVID-19 than were people in the same age group who had received only two jabs and were studied during a similar time period .
Study Design:
The Phase-III study is designed to evaluate the immunogenicity and safety of volunteers who receive either BBV154 vaccine via intranasal route or BBV152 vaccine via intramuscular route or COVISHIELD via intramuscular route when administered as booster dose in individuals previously vaccinated with EUA vaccines in India .A total of 875 participants will be enrolled, randomized and will be conducted in open labeled manner.
Group 1 (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.
Group 2 (BBV152 in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Group 3 (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine via intranasal route, in individuals previously vaccinated with COVISHIELD.
Group 4 (BBV152 in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVISHIELD.
Group 5 (COVISHIELD in COVISHIELD recipients) ) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
In addition to administering the vaccine, a series of blood samples (Immunogenicity Subset) will be collected for analyzing serum for immunological assessments.
A subset of 150 participants each in Groups 1 \&3 and 75 participants each in Groups 2, 4, and 5 will be assessed for immunogenicity. Among this subset an additional 10 mL blood and 5 mL of saliva will be collected from 40 participants each in Groups 1 \&3 and 20 participants each in Groups 2, 4, and 5 to assess the cell-mediated immune response and mucosal immunity, respectively.
STUDY PROCEDURES:-
Visit 1: Baseline (Day 0):
- The participant will be screened for eligibility based on medical history, vitals, and physical examination.
- If the participant is eligible (in good general health or stable pre-existing disease as per the discretion of the Principal investigator), a blood sample will be withdrawn prior to vaccination for all the participants.
- Blood sample (5 mL) will be collected from the subset of participants (n=150 each in Groups 1 \&3 and n=75 each in Groups 2, 4, and 5).
- 5 mL saliva and additional blood sample (10 mL for PBMC) will be collected to assess the secretary IgA Ab titer and cell mediated immune response in subset (n=40 in groups 1\&3 and n=20 in groups2,4,5).
- A study vaccine will be administered. Following vaccination, participants will remain at the study site for at least 30 minutes of observation to record any immediate adverse event.
- Diary card will be distributed to the participants.
- Telephonic follow-up at 15 ± 2 days intervals for assessing health status, and general and COVID-19 symptoms history.
Visit 2 (Day 28 + 2 days):
- Study participants will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- For the humoral immunogenicity subset, 5mL of blood will be collected and processed for serum for assessing neutralizing responses (150 each in Groups 1 \&3 and n=75 each in Groups 2, 4, and 5).
- 5 mL saliva and additional blood sample (10 mL for PBMC) will be collected to assess the secretary IgA Ab titer and cell mediated immune response in subset (n=40 in groups 1\&3 and n=20 in groups2,4,5)
- Telephonic follow-up for all the other participants at 15±2 days intervals for assessing health status, and general and COVID-19 symptoms history.
Visit 3 (Day 56 ± 7 days):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- For the humoral immunogenicity subset, 5mL of blood will be collected and processed for serum for assessing neutralizing responses (150 each in Groups 1 \&3 and n=75 each in Groups 2, 4, and 5).
- 5 mL saliva and additional blood sample (10 mL for PBMC) will be collected to assess the secretary IgA Ab titer and cell mediated immune response in subset (n=40 in groups 1\&3 and n=20 in groups2,4,5)
- Telephonic follow-up for all the other participants at 15±2 days intervals for assessing health status, and general and COVID-19 symptoms history.
Visit 4 (Day 90± 7 days):
Telephonic follow-up for all the other participants for assessing health status, and general and COVID-19 symptoms history.
Visit 5 (Day 180 ± 7 days):
Telephonic follow-up for all the other participants for assessing health status, and general and COVID-19 symptoms history
Safety Monitoring:
Subjects will be observed for 30 minutes after vaccination for immediate adverse events. Active surveillance will be conducted for all participants for seven days after vaccination to ascertain information on solicited adverse events ("Reactogenicity").
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1(BBV154 in COVAXIN recipients) | Active comparator | Biological: BBV154 Intranasal Vaccine250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN. |
| Group 2 (COVAXIN in COVAXIN recipients) | Active comparator | Biological: Intramuscular vaccine COVAXIN125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN. |
| Group 3 (BBV154 in COVISHIELD recipients) | Active comparator | Biological: BBV154 Intranasal Vaccine250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD. |
| Group 4(COVAXIN in COVISHIELD recipients) | Active comparator | Biological: Intramuscular vaccine COVAXIN125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD. |
| Group 5 (COVISHIELD in COVISHIELD recipients) | Active comparator | Biological: Covishield125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide written informed consent.
- Participants of either gender of age ≥18 years.
- Received and completed COVID-19 vaccine under Emergency Use Authorization (EUA) dosing guidelines at least 6 ± 1 month (after receipt of second dose of EUA vaccine) prior to enrollment, confirmed by the electronic Covid-19 Certificate (CoWIN).
- Expressed interest and availability to fulfill 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 vaccination.
Key exclusion criteria (16 listed)
- Known history of COVID-19 infection.
- 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 of vaccine).
- Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness such as an upper respiratory infection or gastroenteritis within three days prior to vaccination.
- Medical problems because 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.
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 Intranasal VaccineAdministered BBV154 vaccine in form of drops (0.5 mL) via intranasal route | Biological | Group 1(BBV154 in COVAXIN recipients), Group 3 (BBV154 in COVISHIELD recipients) |
| Intramuscular vaccine COVAXINAdministered BBV152 vaccine via intramuscular route | Biological | Group 2 (COVAXIN in COVAXIN recipients), Group 4(COVAXIN in COVISHIELD recipients) |
| CovishieldAdministered vaccine via intramuscular route | Biological | Group 5 (COVISHIELD in COVISHIELD recipients) |
Primary outcome
Geometric mean titres 1
Time frame: baseline
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres 2
Time frame: Day 28+2
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres 3
Time frame: Day 56 ± 7
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
9 secondary outcomes
Geometric mean titres 4
Time frame: Day 28+2
Geometric mean titres 5
Time frame: Day 56 ± 7
Cell mediated immune response
Time frame: Day 28+2
Cell mediated immune response
Time frame: Day 56 ± 7
Geometric mean titres
Time frame: Day 28+2
Geometric mean titres (GMTs)
Time frame: Day 56 ± 7
adverse events reported
Time frame: 7 days after vaccination
adverse events of special interest reported
Time frame: throughout the study duration 7 months
vaccine induced thrombosis and thrombocytopenia
Time frame: throughout the study duration 7 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 5 Oct 2022.
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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.
Dr. Sanjay Rai, MBBS,MD principal investigator
All India Institute of Medical Sciences
Dr Chandramani Singh, MBBS,MD principal investigator
All India Institute of Medical Sciences
Dr Anil Kumar Pandey, MBBS,MD principal investigator
ESIC Medical College and Hospital Faridabad
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BBV154 Intranasal Vaccine, Intramuscular vaccine COVAXIN and Covishield in people with COVID-19 Respiratory Infection, run by Bharat Biotech International Limited at 9 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 8 inclusion and 16 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 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Geometric mean titres 1 (time frame: baseline). 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 5 Oct 2022.