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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- SARS-CoV Infection
- Sponsor
- Bharat Biotech International Limited
- Enrollment
- 175
- Locations
- 4
- Primary Endpoint
- The incidence of unsolicited adverse events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study is designed to evaluate the safety, reactogenicity, and immunogenicity of three groups of healthy volunteers who receive either intranasal single dose (vaccine on Day 0 and placebo on Day 28) or two-dose (vaccine on Day 0 and 28) of BBV154 vaccine or Placebo (on Day 0 and day 28). A total of 175 subjects will be enrolled in 2:2:1 ratio and will be conducted in a double-blinded manner.
To assess the safety of the vaccine, each participant will record symptoms in a diary card for 7 days after each dose. Safety and laboratory tests and physical exams will also be performed.
Blood samples and saliva samples be collected to assess the immune response from the vaccine.
An interim report based on the safety and immunogenicity of the vaccine (BBV154) will be notified to the Central Drugs Standard Control Organization (CDSCO), India, for further progressing the clinical development of the vaccine. This unblinded interim report will contain a detailed analysis of the data based on the primary and secondary objectives of all visits through Day 42 (Immunogenicity & Safety).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to provide written informed consent.
- •Participants of either gender of age between ≥18 to ≤60 years.
- •Good general health as determined by the discretion of investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and \<140 mm Hg; diastolic ≥ 60 mm Hg and \<90 mm Hg; oral temperature \<100.4ºF), medical history, and physical examination).
- •Expressed interest and availability to fulfil the study requirements.
- •For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination.
- •Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination.
- •Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination.
- •Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination.
- •Agrees not to participate in another clinical trial at any time during the study period.
- •Agrees to remain in the study area for the entire duration of the study.
Exclusion Criteria
- •History of any other COVID-19 investigational/or licensed vaccination.
- •Unacceptable laboratory abnormality from screening (prior to first vaccination) or safety testing, as listed below \[Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen\].
- •(Subjects will be informed if their results are positive for hepatitis C, HIV 1 \& 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for follow up of these abnormal laboratory tests.)
- •Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA or CLIA method.
- •History of facial nerve paralysis
- •History of cold, sneezing, nasal obstruction in the past 3 days.
- •Prescribed usage of any nasal spray/or nasal drop medication.
- •Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded)
- •For women of child bearing potential, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
- •Temperature \>38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
Outcomes
Primary Outcomes
The incidence of unsolicited adverse events
Time Frame: Through study completion, an average of 6 months
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
Incidence of immediate adverse events.
Time Frame: within 2 hours post each vaccination
Secondary Outcomes
- To evaluate the humoral immune responses of BBV154(Through study completion, an average of 6 months)
- To evaluate the immune responses against spike protein of SARS-CoV-2 virus and Adenovirus vector(Through study completion, an average of 6 months)
- To compare the humoral responses between single dose group and double dose group.(Through study completion, an average of 6 months)
- Vaccine induced cell mediated antigen specific T-cell responses across the three groups.(Through study completion, an average of 6 months)
- Vaccine induced cell mediated antigen specific cytokines across the three groups. To evaluate the vaccine induced Cell mediated immune response.(Through study completion, an average of 6 months)
- To evaluate the safety of the vaccine in terms of assessing adverse event of special interest (AESI)(Through study completion, an average of 6 months)
- To evaluate the vaccine secretory IgA antibody response.(Through study completion, an average of 6 months)