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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited adverse events | Incidence of solicited adverse events post booster vaccination in all subjects. | 14 days |
| Incidence of serious adverse events | Incidence of serious adverse events post booster vaccination in all subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Shi Min Ng | Hospital Ampang | Principal Investigator |
| Norliza Zainudin | Hospital Selayang | Principal Investigator |
| Sunita Bavanandam | Kuala Lumpur General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ampang | Ampang | Selangor | 68000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39482336 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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).
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Observer-blind clinical trial
| mRNA vaccine BNT162b2 (Pfizer) | Biological | Subjects will be randomized to receive a second booster dose of BNT162b2. |
|
| Up to 24 weeks |
| Incidence of adverse events of special interest (AESI) | Incidence of AESI post booster vaccination in all subjects. | Up to 24 weeks |
| 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. |
| 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. |
| Level of saliva IgA antibodies by ELISA. | 14 days post booster vaccination |
| Level of serum functional neutralizing antibodies by cPass Genscript | 14 days post booster vaccination |
| Level of serum Anti-Spike IgG by ELISA. | 14 days post booster vaccination |
| Level of anti S-RBD IgG by ELISA. | 14 days post booster vaccination |
| Level of T cell responses by Intracellular Cytokine Staining (Th1/Th2) in subgroup subjects. | Up to 24 weeks |
| Level of T cell response by Enzyme-linked Immunospot (Elispot) in subgroup subjects. | Up to 24 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |