- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05517642
IH Convidecia as Second Booster Dose Against Breakthrough Infections
Immunogenicity, Efficacy and Safety of Inhaled (IH) Viral Vectored Vaccine (Convidecia, CanSino) as Second Booster Dose Against Emerging Variants of Concern (VOC) of SARS-CoV-2 to Prevent Breakthrough Infections. A Randomized Observer-blind Controlled Trial.
This will be a randomized single-blind controlled trial to determine the immunogenicity, efficacy and safety of IH Convidecia (CanSino), as a second booster vaccination against Omicron and other emerging VOCs to prevent breakthrough infections among people with a sub-optimal immune response to the first booster dose.
These subjects will be randomized in a ratio of 1:1 to receive a second booster dose of IH Convidecia vaccine (treatment arm), or a second booster dose of mRNA vaccine BNT162b2 (Pfizer).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Xiaoyuan Zhao
- Phone Number: 022-58213600-6051
- Email: xiaoyuan.zhao@cansinotech.com
Study Locations
-
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Selangor Darul Ehsan
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Ampang, Selangor Darul Ehsan, Malaysia, 68000
- Hospital Ampang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant is willing and able to give written informed consent for participation in the study.
- Male or Female, aged 18 years or above and in good health as determined by study clinician. Participants may have well controlled or mild-moderate comorbidity.
- Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation.
- In the Investigator's opinion, participant is able and willing to comply with all trial requirements.
- At least 16 weeks after first booster dose of vaccination.
Exclusion Criteria:
- Confirmed cases, suspected cases or asymptomatic cases of COVID-19.
- Self-reported history of SARS and MERS infection.
- Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination.
- Receipt of any SARS-COV-2 vaccine after first dose of booster vaccination.
- Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
- Any history of anaphylaxis.
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Suspected or known current alcohol or drug dependency.
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).
- Participant with life expectancy of less than 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ad5-nCoV-IH
Participates age 18 or older who have completed a course of primary and first booster vaccination at least 16 weeks before, and who have sub-optimal antibody response to the first booster dose, will receive a second booster dose of IH Convidecia vaccine.
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Subjects will be randomized to receive a second booster dose of IH Convidecia vaccine (treatment arm)
|
Active Comparator: mRNA vaccine BNT162b2 (Pfizer)
Participates age 18 or older who have completed a course of primary and first booster vaccination at least 16 weeks before, and who have sub-optimal antibody response to the first booster dose,will receive a second booster dose of mRNA vaccine BNT162b2 (Pfizer).
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Subjects will be randomized to receive a second booster dose of BNT162b2.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Level of saliva IgA antibodies by ELISA.
Time Frame: 28 days post booster vaccination
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28 days post booster vaccination
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Level of serum functional neutralizing antibodies by cPass Genscript
Time Frame: 28 days post booster vaccination
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28 days post booster vaccination
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Level of serum Anti-Spike IgG by ELISA.
Time Frame: 28 days post booster vaccination
|
28 days post booster vaccination
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Level of anti S-RBD IgG by ELISA.
Time Frame: 28 days post booster vaccination
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28 days post booster vaccination
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Level of serum Anti-Nucleocapsid IgG by ELISA.
Time Frame: 28 days post booster vaccination
|
28 days post booster vaccination
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Baseline level of Anti-Ad5 antibodies by ChemiLuminescence.
Time Frame: Day 0
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Day 0
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Level of pseudo neutralising antibodies against the wild-type original strain and Beta, Delta, Omicron and emerging VOCs by ELISA.
Time Frame: 28 days post booster vaccination
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28 days post booster vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of solicited adverse events
Time Frame: 14 days
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Incidence of solicited adverse events post booster vaccination in all subjects.
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14 days
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Incidence of serious adverse events
Time Frame: Up to 24 weeks
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Incidence of serious adverse events post booster vaccination in all subjects.
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Up to 24 weeks
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Incidence of adverse events of special interest (AESI)
Time Frame: Up to 24 weeks
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Incidence of AESI post booster vaccination in all subjects.
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Up to 24 weeks
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Efficacy against COVID-19 infection and transmission
Time Frame: At least 14 days post booster dose.
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RT-PCR-confirmed Covid-19 breakthrough infection, whether symptomatic or not.
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At least 14 days post booster dose.
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Efficacy against COVID-19 infection and transmission
Time Frame: Within 7 days after the sample date of the index case.
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RT-PCR-confirmed Covid-19 secondary attack rate among household members after an index case is detected.
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Within 7 days after the sample date of the index case.
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Level of saliva IgA antibodies by ELISA.
Time Frame: 14 days post booster vaccination
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14 days post booster vaccination
|
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Level of serum functional neutralizing antibodies by cPass Genscript
Time Frame: 14 days post booster vaccination
|
14 days post booster vaccination
|
|
Level of serum Anti-Spike IgG by ELISA.
Time Frame: 14 days post booster vaccination
|
14 days post booster vaccination
|
|
Level of anti S-RBD IgG by ELISA.
Time Frame: 14 days post booster vaccination
|
14 days post booster vaccination
|
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Level of T cell responses by Intracellular Cytokine Staining (Th1/Th2) in subgroup subjects.
Time Frame: Up to 24 weeks
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Up to 24 weeks
|
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Level of T cell response by Enzyme-linked Immunospot (Elispot) in subgroup subjects.
Time Frame: Up to 24 weeks
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Up to 24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sharon Shi Min Ng, Hospital Ampang
- Principal Investigator: Sunita Bavanandam, Kuala Lumpur General Hospital
- Principal Investigator: Norliza Zainudin, Hospital Selayang
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT 2022-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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