Clinical trial NCT05517642: IH Convidecia as Second Booster Dose Against Breakthrough Infections
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: Inhaled
Convidecia
Safety
Immunogenicity
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Level of saliva IgA antibodies by ELISA.
timeFrame: 28 days post booster vaccination
measure: Level of serum functional neutralizing antibodies by cPass Genscript
timeFrame: 28 days post booster vaccination
measure: Level of serum Anti-Spike IgG by ELISA.
timeFrame: 28 days post booster vaccination
measure: Level of anti S-RBD IgG by ELISA.
timeFrame: 28 days post booster vaccination
measure: Level of serum Anti-Nucleocapsid IgG by ELISA.
timeFrame: 28 days post booster vaccination
measure: Baseline level of Anti-Ad5 antibodies by ChemiLuminescence.
timeFrame: Day 0
measure: Level of pseudo neutralising antibodies against the wild-type original strain and Beta, Delta, Omicron and emerging VOCs by ELISA.
timeFrame: 28 days post booster vaccination
Secondary outcomes:
measure: Incidence of solicited adverse events
timeFrame: 14 days
measure: Incidence of serious adverse events
timeFrame: Up to 24 weeks
measure: Incidence of adverse events of special interest (AESI)
timeFrame: Up to 24 weeks
measure: Efficacy against COVID-19 infection and transmission
timeFrame: At least 14 days post booster dose.
measure: Efficacy against COVID-19 infection and transmission
timeFrame: Within 7 days after the sample date of the index case.
measure: Level of saliva IgA antibodies by ELISA.
timeFrame: 14 days post booster vaccination
measure: Level of serum functional neutralizing antibodies by cPass Genscript
timeFrame: 14 days post booster vaccination
measure: Level of serum Anti-Spike IgG by ELISA.
timeFrame: 14 days post booster vaccination
measure: Level of anti S-RBD IgG by ELISA.
timeFrame: 14 days post booster vaccination
measure: Level of T cell responses by Intracellular Cytokine Staining (Th1/Th2) in subgroup subjects.
timeFrame: Up to 24 weeks
measure: Level of T cell response by Enzyme-linked Immunospot (Elispot) in subgroup subjects.
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Ampang
country: Malaysia
facility: Hospital Ampang
state: Selangor Darul Ehsan
Study officials:
affiliation: Hospital Ampang
name: Sharon Shi Min Ng
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Selayang
name: Norliza Zainudin
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuala Lumpur General Hospital
name: Sunita Bavanandam
role: PRINCIPAL_INVESTIGATOR
References: