IH Convidecia as Second Booster Dose Against Breakthrough Infections

NCT05517642 | Completed Phase 3

• 1 other identifier: CT 2022-01
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19

Keywords

Inhaled; Convidecia; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (7)

• Level of saliva IgA antibodies by ELISA.

  28 days post booster vaccination

• Level of serum functional neutralizing antibodies by cPass Genscript

  28 days post booster vaccination

• Level of serum Anti-Spike IgG by ELISA.

  28 days post booster vaccination

• Level of anti S-RBD IgG by ELISA.

  28 days post booster vaccination

• Level of serum Anti-Nucleocapsid IgG by ELISA.

  28 days post booster vaccination

• Baseline level of Anti-Ad5 antibodies by ChemiLuminescence.

  Day 0

• 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 Outcomes (11)

• Incidence of solicited adverse events

  14 days

• Incidence of serious adverse events

  Up to 24 weeks

• Incidence of adverse events of special interest (AESI)

  Up to 24 weeks

• Efficacy against COVID-19 infection and transmission

  At least 14 days post booster dose.

• Efficacy against COVID-19 infection and transmission

  Within 7 days after the sample date of the index case.

Study Arms (2)

Ad5-nCoV-IH

EXPERIMENTAL

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.

Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

mRNA vaccine BNT162b2 (Pfizer)

ACTIVE COMPARATOR

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).

Biological: mRNA vaccine BNT162b2 (Pfizer)

Interventions

Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) BIOLOGICAL

Subjects will be randomized to receive a second booster dose of IH Convidecia vaccine (treatment arm)

Ad5-nCoV-IH

mRNA vaccine BNT162b2 (Pfizer) BIOLOGICAL

Subjects will be randomized to receive a second booster dose of BNT162b2.

mRNA vaccine BNT162b2 (Pfizer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Hospital Ampang

Ampang, Selangor, 68000, Malaysia

Location

Related Publications (1)

• Chew CK, Wang R, Bavanandan S, Zainudin N, Zhao X, Ahmed S, Nair D, Hou L, Yahya R, Ch'ng SS, Pang LH, Abdul Aziz A, Huang H, Rajasuriar R, Wu S, Zhang Z, Wang X, Chun GY, Mohd Norzi A, Cheah KY, Lee YL, Wan Mohamad WH, Mohd Din MR, Wan Ahmad Kamil WMR, Tan MH, Xu X, Wang L, Yan M, Liu Y, Chin VK, Teo JS, Lim TO, Zhu T, Gou J, Ng SSM. Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial. NPJ Vaccines. 2024 Oct 31;9(1):209. doi: 10.1038/s41541-024-01003-x.

  PMID: 39482336 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon Shi Min Ng

  Hospital Ampang

  PRINCIPAL INVESTIGATOR

• Norliza Zainudin

  Hospital Selayang

  PRINCIPAL INVESTIGATOR

• Sunita Bavanandam

  Kuala Lumpur General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Observer-blind clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 22, 2022
• First Posted: August 26, 2022
• Study Start: September 20, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: September 8, 2023

Record last verified: 2022-10

Locations

MY (1)