IH Convidecia as Second Booster Dose Against Breakthrough Infections

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517642
• Other study ID #: CT 2022-01
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
Subjects will be randomized to receive a second booster dose of IH Convidecia vaccine (treatment arm)
• mRNA vaccine BNT162b2 (Pfizer)
Subjects will be randomized to receive a second booster dose of BNT162b2.

Locations

Country	Name	City	State
Malaysia	Hospital Ampang	Ampang	Selangor Darul Ehsan

Sponsors (1)

Lead Sponsor	Collaborator
CanSino Biologics Inc.

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of saliva IgA antibodies by ELISA.		28 days post booster vaccination
Primary	Level of serum functional neutralizing antibodies by cPass Genscript		28 days post booster vaccination
Primary	Level of serum Anti-Spike IgG by ELISA.		28 days post booster vaccination
Primary	Level of anti S-RBD IgG by ELISA.		28 days post booster vaccination
Primary	Level of serum Anti-Nucleocapsid IgG by ELISA.		28 days post booster vaccination
Primary	Baseline level of Anti-Ad5 antibodies by ChemiLuminescence.		Day 0
Primary	Level of pseudo neutralising antibodies against the wild-type original strain and Beta, Delta, Omicron and emerging VOCs by ELISA.		28 days post booster vaccination
Secondary	Incidence of solicited adverse events	Incidence of solicited adverse events post booster vaccination in all subjects.	14 days
Secondary	Incidence of serious adverse events	Incidence of serious adverse events post booster vaccination in all subjects.	Up to 24 weeks
Secondary	Incidence of adverse events of special interest (AESI)	Incidence of AESI post booster vaccination in all subjects.	Up to 24 weeks
Secondary	Efficacy against COVID-19 infection and transmission	RT-PCR-confirmed Covid-19 breakthrough infection, whether symptomatic or not.	At least 14 days post booster dose.
Secondary	Efficacy against COVID-19 infection and transmission	RT-PCR-confirmed Covid-19 secondary attack rate among household members after an index case is detected.	Within 7 days after the sample date of the index case.
Secondary	Level of saliva IgA antibodies by ELISA.		14 days post booster vaccination
Secondary	Level of serum functional neutralizing antibodies by cPass Genscript		14 days post booster vaccination
Secondary	Level of serum Anti-Spike IgG by ELISA.		14 days post booster vaccination
Secondary	Level of anti S-RBD IgG by ELISA.		14 days post booster vaccination
Secondary	Level of T cell responses by Intracellular Cytokine Staining (Th1/Th2) in subgroup subjects.		Up to 24 weeks
Secondary	Level of T cell response by Enzyme-linked Immunospot (Elispot) in subgroup subjects.		Up to 24 weeks