COVID-19Phase 3NCT05169008

A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adolescents

A Phase 3 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) and Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) in people with COVID-19, run by CanSino Biologics Inc. at 2 sites in Chile.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a multicenter, randomized, and open-label study to evaluate the immune responses and safety profiles of children aged 6-12 years and adolescents aged 13-17 years receiving Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation) ≥ 90 days after receiving two doses of CoronaVac. Read more about this study

Who is it for?: Ages 6 to 17 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) and Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 2 sitesChile
Study dates: 25 Feb 2022to 13 Jan 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 6 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children aged 6-12 years and adolescents aged 13-17 years at the time of randomization.
Have received a complete two dose schedule of CoronaVac for ≥ 90 days.
Obtain written informed assent from participants and consent from parents, guardians or legal representatives.
Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.

Who cannot join

Have a history of seizures, epilepsy, encephalopathy, psychosis.
History of anaphylaxis to any vaccine component.
Positive urine pregnancy test result, pregnant, lactation women. Female had menarche must conduct the urine pregnancy test.
Congenital or acquired angioedema/neuroedema .
Medical history of Guillain-Barré syndrome.
Have had asthma attacks within 2 years.

Show all 19Show fewer

Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
Asplenia or functional absence of spleen.
Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
Any confirmed or suspected immunosuppressive or immunodeficient state; received immunosuppressive therapy, cytotoxic therapy, or chronic corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) within the past 6 months.
Have chronic systematic infection or chronic pulmonary disease
Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
Receiving anti-tuberculosis or cancer treatment.
History of COVID-19 disease.
Have a positive result at the examination of rapid SARS-CoV-2 antibody assay (S-RBD IgG) before vaccination.
Have received COVID vaccines other than CoronaVac.
Received or plan to receive any non-COVID vaccines (licensed or investigational), within 14 days before and after study vaccination.
Current diagnosis of or treatment for cancer, e.g. leukemia.
Any other significant disease, disorder or finding 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.

Trial locations and contacts

2 sites in 1 country.

Chile2 sites

Hospital Base de Osorno
Osorno, Los Lagos Region
Hospital Carlos van Buren
Valparaíso, Valparaiso

Other trials in Chile

About this study

Official title: A Multicenter, Randomized, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Intramuscular and Inhaled COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years Who Have Been Immunized With Two Doses of CoronaVac

Read the detailed description

A total of 1000 participants will be equally divided into the two study groups, children of 6-12 years and adolescents of 13-17 years. In each age group, they will have an equal chance to received either one dose of Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation). The enrollment of the children group will start after the safety profiles in 7 days post-vaccination of the adolescent group have been deemed acceptable. Investigators should try to balance the age and sex of the participants during enrollment.

Conditions: COVID-19
Being tested: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
Keywords: COVID-19 Vaccine, Inhalation, Ad5, Safety, Immunogenicity, Children, Adolescents
Medical subject headings: COVID-19, Respiratory Aspiration, Alzheimer Disease 5

What participants receive

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

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Biological
Intramuscular injection
Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)Biological
Nebulized inhalation through the mouth

Study groups in NCT05169008
Study group	Role	What they receive
Vaccine Group	Experimental	1000 participants，500 children aged 6-12 years and 500 adolescents aged 13-17 years, Ad5-nCoV or Ad5-nCoV-IH, ≥90 days after two doses of CoronaVac. Intramuscular injection or nebulized inhalation. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

What is being measured

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

Incidence of SAE
Evaluate the incidence of severe adverse events (SAE)
Measured: Day 0 to 12 months post IM or IH
Immunogenicity of S-RBD IgG antibody
GMC of S-RBD IgG antibody by Elisa post vaccination
Measured: 28 days post IM or IH

Secondary outcomes (8)

Incidence of Adverse Reactions (ARs)
Incidence of solicited adverse reactions (ARs)
Measured: Within 14 days post IM or IH
The incidence of AR and AE
Incidence of AR and AE within 28 days
Measured: Within 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
GMC of S-RBD IgG antibody post vaccination by ELISA
Measured: 14 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Seroconversion rate of S-RBD IgG antibody post vaccination by ELISA
Measured: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
GMI of S-RBD IgG antibody post vaccination by ELISA
Measured: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
GMT of pseudo-virus neutralizing antibody by ELISA
Measured: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
GMI of pseudo-virus neutralizing antibody by ELISA
Measured: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Seroconversion rate of pseudo-virus neutralizing antibody by ELISA
Measured: 14 and 28 days post IM or IH

Timeline

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

25 Feb 202213 Jan 2023

First posted23 Dec 2021
Study start25 Feb 2022
Primary completion13 Jan 2023
Study completion13 Jan 2023

Why it stopped: Difficulty recruiting subjects, so the study was terminated.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05169008
Sponsor's protocol ID: CS-CTP-AD5NCOV-PDⅢ
Status last verified: Jan 2022
First submitted: 10 Dec 2021
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Intramuscular and Inhaled COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years Who Have Been Immunized With Two Doses of CoronaVac
ClinicalTrials.gov ID: NCT05169008
Acronym / sponsor ID: CS-CTP-AD5NCOV-PDⅢ
Conditions: COVID-19
Keywords: COVID-19 Vaccine, Inhalation, Ad5, Safety, Immunogenicity, Children, Adolescents
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty recruiting subjects, so the study was terminated.
Enrolment: 91 participants (actual)
Lead sponsor: CanSino Biologics Inc.Industry (pharma, biotech, devices)
Collaborators: Beijing Institute of Biotechnology
Study start: 25 Feb 2022 (actual)
Primary completion: 13 Jan 2023 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 23 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vaccine Group	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)1000 participants，500 children aged 6-12 years and 500 adolescents aged 13-17 years, Ad5-nCoV or Ad5-nCoV-IH, ≥90 days after two doses of CoronaVac. Intramuscular injection or nebulized inhalation.

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Children aged 6-12 years and adolescents aged 13-17 years at the time of randomization.
Have received a complete two dose schedule of CoronaVac for ≥ 90 days.
Obtain written informed assent from participants and consent from parents, guardians or legal representatives.
Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.

Key exclusion criteria (19 listed)

Have a history of seizures, epilepsy, encephalopathy, psychosis.
History of anaphylaxis to any vaccine component.
Positive urine pregnancy test result, pregnant, lactation women. Female had menarche must conduct the urine pregnancy test.
Congenital or acquired angioedema/neuroedema .
Medical history of Guillain-Barré syndrome.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Intramuscular injection	Biological	Vaccine Group
Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)Nebulized inhalation through the mouth	Biological	Vaccine Group

Primary outcome

Incidence of SAE
Time frame: Day 0 to 12 months post IM or IH
Evaluate the incidence of severe adverse events (SAE)
Immunogenicity of S-RBD IgG antibody
Time frame: 28 days post IM or IH
GMC of S-RBD IgG antibody by Elisa post vaccination

8 secondary outcomes

Incidence of Adverse Reactions (ARs)
Time frame: Within 14 days post IM or IH
The incidence of AR and AE
Time frame: Within 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Time frame: 14 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Time frame: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Time frame: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Time frame: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Time frame: 14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody
Time frame: 14 and 28 days post IM or IH

Results and safety

The study was stopped early (reason given: Difficulty recruiting subjects, so the study was terminated.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephania Passalacqua principal investigator

Hospital Base de Osorno, Chile

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 19 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: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. 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 was stopped early (reason given: Difficulty recruiting subjects, so the study was terminated.). Results are not available in the source record.

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?

Incidence of SAE (time frame: Day 0 to 12 months post IM or IH). The study lists 2 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 NCT05169008.

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 15 Jun 2023.