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AzTrials

COVID-19Phase 3NCT05442684

A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine

A Phase 3 study testing Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector), Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation and mRNA-based COVID-19 vaccine in people with COVID-19, run by CanSino Biologics Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1. 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?
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector), Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation and mRNA-based COVID-19 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Nov 2022to 30 Jun 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

  • Participants aged 18 years and above at the time of screening.
  • Received the 1st booster vaccination at least 180 days earlier.
  • Agree to attend all visits and sign the written informed consent form.

Who cannot join

  • Have a history of seizures, epilepsy, encephalopathy, psychosis.
  • History of severe anaphylaxis or allergy to any vaccine component.
  • Positive urine pregnancy test result, pregnant, lactating women.
  • Medical history of Guillain-Barré syndrome.
  • Have had asthma attacks within 2 years.
  • Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
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  • Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
  • Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.
  • Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
  • Current diagnosis or receiving treatment for tuberculosis or cancer.
  • History of SARS-CoV-2 infection for less than 3 months.
  • Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.
  • Have an axillary temperature of > 37.0℃.
  • Any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

About this study

Official title: A Multicenter, Randomized, and Observer-blind Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-based COVID-19 Vaccine Against Coronavirus Variants in Adults (≥ 18 Years) Who Have Been Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.

Read the detailed description

This is a multicenter, randomized, observer-blind, and parallel-controlled clinical study to evaluate the immune responses and safety profiles in adults (≥ 18 years) receiving investigational products (intramuscular injection or nebulized inhalation) ≥ 180 days after the immunization of 2 doses of BNT162b2 vaccines plus one dose of booster AZD1222 vaccine. This study will enroll about 30% participants aged 60 years and above.

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.

Conditions
COVID-19
Being tested
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector), Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation, mRNA-based COVID-19 vaccine
Medical subject headings
COVID-19

What participants receive

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

  • Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)Biological

    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O

  • Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for InhalationBiological

    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O-IH

  • mRNA-based COVID-19 vaccineBiological

    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of mRNA-based COVID-19 vaccine

Study groups in NCT05442684
Study groupRoleWhat they receive
Ad5-nCoV/O groupExperimentalNot described
Receives: Biological: Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)
Ad5-nCoV/O-IH groupExperimentalNot described
Receives: Biological: Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation
mRNA-based COVID-19 vaccine groupActive comparatorNot described
Receives: Biological: mRNA-based COVID-19 vaccine

What is being measured

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

  1. Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.

    The geometric mean titers (GMT) of anti-Omicron pseudovirus neutralizing antibody on Day 28 post vaccination in all participants

    Measured: Day 28 post vaccination

Secondary outcomes (17)

  1. Incidence of Adverse Reactions (ARs)

    The incidence of adverse reactions (ARs) within 30 min post vaccination.

    Measured: within 30 min post vaccination

  2. Incidence of Adverse Reactions (ARs)

    The incidence of adverse reactions (ARs) within 14 days post vaccination

    Measured: within 14 days post vaccination

  3. The incidence of AR and AE

    The incidence of ARs/adverse events (AEs) within 28 days post vaccination.

    Measured: within 28 days post vaccination

  4. Incidence of SAE

    The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post vaccination.

    Measured: within 12 months post vaccination

  5. Immunogenicity of pseudovirus neutralizing antibody

    The GMT, geometric mean increase fold (GMI) and sero-conversion rate (SCR) of anti-Omicron pseudovirus neutralizing antibody on Day 14 and Day 28 post-vaccination in all participants.

    Measured: on Day 14 and Day 28 post-vaccination

  6. Immunogenicity of S-RBD IgG antibody

    The geometric mean concentration (GMC), GMI and SCR of anti-Omicron S-RBD IgG antibody on Day 14 and Day 28 post-vaccination in all participants.

    Measured: on Day 14 and Day 28 post-vaccination

  7. Immunogenicity of S-RBD serum IgA antibody

    The GMT, GMI, and SCR of anti-Omicron S-RBD serum IgA antibody on Day 14 and Day 28 post-vaccination in all participants.

    Measured: on Day 14 and Day 28 post-vaccination

  8. Immunogenicity of pseudovirus neutralizing antibody

    The GMT, GMI and SCR of anti-Omicron pseudovirus neutralizing antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.

    Measured: on Month 3, Month 6, and Month 12 post-vaccination

  9. Immunogenicity of S-RBD IgG antibody

    The GMC, GMI and SCR of anti-Omicron S-RBD IgG antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.

    Measured: on Month 3, Month 6, and Month 12 post-vaccination

  10. Immunogenicity of S-RBD serum IgA antibody

    The GMC, GMI and SCR of anti-Omicron S-RBD serum IgA antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup

    Measured: on Month 3, Month 6, and Month 12 post-vaccination

  11. Virological confirmed COVID-19 cases

    The number of virological confirmed COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.

    Measured: from Day 14 post-vaccination

  12. Virological confirmed severe COVID-19 cases.

    The number of virological confirmed severe COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.

    Measured: from Day 14 post-vaccination

  13. Virological confirmed asymptomatic COVID-19 cases

    The number of virological confirmed asymptomatic COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.

    Measured: from Day 14 post-vaccination

  14. Immunogenicity of anti-Nucleocapsid antibody

    The GMT of anti-Nucleocapsid antibody before vaccination

    Measured: before vaccination

  15. Immunogenicity of saliva secretory IgA (SIgA)

    The GMC, GMI, and SCR of saliva secretory IgA (SIgA) on Day 14 and Day 28 post-vaccination in participants of the immunogenicity subgroup.

    Measured: on Day 14 and Day 28 post-vaccination

  16. The level and positive rate of interferon γ (IFN-γ)

    The level and positive rate of interferon γ (IFN-γ) on Day 14 and Day 28 after the 2nd booster dose.

    Measured: on Day 14 and Day 28 after the 2nd booster dose

  17. The neutralizing antibody against other VOCs or emerging variant(s).

    The neutralizing antibody on Day 28 against VOCs or other emerging variants.

    Measured: on Day 28

Timeline

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

  1. First posted5 Jul 2022
  2. Study start30 Nov 2022 (estimated)
  3. Primary completion30 Mar 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Why it stopped: The trial protocol was not approved by the regulatory authorities.

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 who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05442684
Sponsor's protocol ID
CTP-AD5NCOV/O-001
Status last verified
Oct 2022
First submitted
16 Jun 2022
Last updated
18 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector), Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation and mRNA-based COVID-19 vaccine in people with COVID-19, run by CanSino Biologics Inc..

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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose. (time frame: Day 28 post vaccination). 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 NCT05442684.

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 18 Jun 2023.

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