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AzTrials

COVID-19Phase 3NCT05517642

IH Convidecia as Second Booster Dose Against Breakthrough Infections

A Phase 3 study testing Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) and mRNA vaccine BNT162b2 (Pfizer) in people with COVID-19, run by CanSino Biologics Inc. at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) and mRNA vaccine BNT162b2 (Pfizer)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
1 siteMalaysia
Study dates
20 Sep 2022to 2 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Ampang

    Ampang, Selangor, 68000

Other trials in Malaysia

About this study

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.

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
Being tested
Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH), mRNA vaccine BNT162b2 (Pfizer)
Keywords
Inhaled, Convidecia, Safety, Immunogenicity
Medical subject headings
COVID-19, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • mRNA vaccine BNT162b2 (Pfizer)Biological

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

Study groups in NCT05517642
Study groupRoleWhat they receive
Ad5-nCoV-IHExperimentalParticipates 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.
Receives: Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
mRNA vaccine BNT162b2 (Pfizer)Active comparatorParticipates 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).
Receives: Biological: mRNA vaccine BNT162b2 (Pfizer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of saliva IgA antibodies by ELISA.

    Measured: 28 days post booster vaccination

  2. Level of serum functional neutralizing antibodies by cPass Genscript

    Measured: 28 days post booster vaccination

  3. Level of serum Anti-Spike IgG by ELISA.

    Measured: 28 days post booster vaccination

  4. Level of anti S-RBD IgG by ELISA.

    Measured: 28 days post booster vaccination

  5. Level of serum Anti-Nucleocapsid IgG by ELISA.

    Measured: 28 days post booster vaccination

  6. Baseline level of Anti-Ad5 antibodies by ChemiLuminescence.

    Measured: Day 0

  7. Level of pseudo neutralising antibodies against the wild-type original strain and Beta, Delta, Omicron and emerging VOCs by ELISA.

    Measured: 28 days post booster vaccination

Secondary outcomes (11)

  1. Incidence of solicited adverse events

    Incidence of solicited adverse events post booster vaccination in all subjects.

    Measured: 14 days

  2. Incidence of serious adverse events

    Incidence of serious adverse events post booster vaccination in all subjects.

    Measured: Up to 24 weeks

  3. Incidence of adverse events of special interest (AESI)

    Incidence of AESI post booster vaccination in all subjects.

    Measured: Up to 24 weeks

  4. Efficacy against COVID-19 infection and transmission

    RT-PCR-confirmed Covid-19 breakthrough infection, whether symptomatic or not.

    Measured: At least 14 days post booster dose.

  5. Efficacy against COVID-19 infection and transmission

    RT-PCR-confirmed Covid-19 secondary attack rate among household members after an index case is detected.

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

  6. Level of saliva IgA antibodies by ELISA.

    Measured: 14 days post booster vaccination

  7. Level of serum functional neutralizing antibodies by cPass Genscript

    Measured: 14 days post booster vaccination

  8. Level of serum Anti-Spike IgG by ELISA.

    Measured: 14 days post booster vaccination

  9. Level of anti S-RBD IgG by ELISA.

    Measured: 14 days post booster vaccination

  10. Level of T cell responses by Intracellular Cytokine Staining (Th1/Th2) in subgroup subjects.

    Measured: Up to 24 weeks

  11. Level of T cell response by Enzyme-linked Immunospot (Elispot) in subgroup subjects.

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2022
  2. Study start20 Sep 2022
  3. Primary completion2 May 2023
  4. Study completion2 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Investigator
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05517642
Sponsor's protocol ID
CT 2022-01
Status last verified
Oct 2022
First submitted
22 Aug 2022
Last updated
8 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39482336

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) and mRNA vaccine BNT162b2 (Pfizer) in people with COVID-19, run by CanSino Biologics Inc. at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of saliva IgA antibodies by ELISA. (time frame: 28 days post booster vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05517642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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