AzTrials
AzTrials

COVID-19Phase 2NCT05330871

Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.

A Phase 2 study testing 1 Nebulized inhalation for booster groups, 2 Nebulized inhalation for booster groups and 3 Nebulized inhalation for booster groups in people with COVID-19, run by Seventh Medical Center of PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a single center, open-label, parallel controlled, and randomized Phase II clinical trial to evaluate the safety and immunogenicity of two types of Recombinant Novel Corona Virus Vaccine (Adenovirus type 5 vector) in population aged 6-17 years who have been previously immunized with 2 doses of inactivated… 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?
1 Nebulized inhalation for booster groups, 2 Nebulized inhalation for booster groups and 3 Nebulized inhalation for booster groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
1 siteChina
Study dates
17 Apr 2022to 30 May 2023
Phase
Phase 2
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

  • Participants aged 6-17 years at the time of enrollment.
  • Obtain written informed assent from participants and consent from parents, guardians or legal representatives.
  • Able and willing to complete all the scheduled study procedures during the whole study follow-up period of 12 months.
  • Have not received any COVID-19 vaccines (for primary groups only).

Who cannot join

  • Medical or family history of seizures, epilepsy, encephalopathy, and psychosis disorders.
  • History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and asthma.
  • History of vaccine related SAEs after receiving any COVID-19 vaccines.
  • Positive urine pregnancy test result, females with child bearing potential (have had menarche).
  • Acute febrile diseases and infectious diseases, medical history of SARS (SARS-CoV-1).
  • Axillary temperature >37.0#.
Show all 30Show fewer
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable by medications.
  • Severe chronic diseases or with advanced stage conditions which cannot be controlled smoothly, such as diabetes, thyroid disease, etc.
  • Congenital or acquired angioedema/neurological edema.
  • Urticaria history within 1 year before receiving the study vaccine.
  • Asplenia or functional aspleenia.
  • Thrombocytopenia or other coagulation disorders (may cause contraindications for intramuscular injection).
  • Trypanophobia.
  • Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, throat redness, and swelling.
  • Lung function abnormalities such as chronic obstructive pulmonary disease and pulmonary fibrosis.
  • Abnormal laboratory test indexes that are clinical significant as judged by the investigator (including white blood cell count, lymphocyte count, eosinophils, neutrophils, platelets, hemoglobin, alanine aminotransferase ALT, aspartate aminotransferase AST, total bilirubin , creatinine, activated partial thromboplastin time) (for sentinel and safety groups only).
  • Respiratory rate ≥ 17 times per minute (for sentinel and safety groups only).
  • History of receiving immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, nebulized corticosteroid therapy in the past 6 months (not including corticosteroid spray treatment for allergic rhinitis, and surface corticosteroid treatment for acute non-complicated dermatitis).
  • Prior administration of blood products in last 4 months.
  • Received other investigational drugs within 1 month before the study.
  • Prior administration of live attenuated vaccines within 1 month before the study.
  • Prior administration of subunit or inactivated vaccines within 14 days before the study.
  • Current anti-tuberculosis therapy.
  • Medical history of Covid-19 disease/infection.
  • History of epidemiological exposure to COVID-19; have traveled to medium or high-risk areas in the past 21 days or have a history of travelling outside the country
  • Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc).
  • Newly emerged situations that meet the first-dose exclusion criteria.
  • Vaccine related SAE post first dose vaccination.
  • Serious allergic reactions post first dose vaccination.
  • Other reasons in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province

    Xiangxi, Hunan, 416199

Other trials in China

About this study

Official title: A Single Center, Open-label, Parallel Controlled, Randomized Phase II Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV-IM, Ad5-nCoV-IH or Inactivated COVID-19 Vaccine in Population 6 to 17 Years of Age

This is a single center, open-label, parallel controlled, and randomized Phase II clinical trial to evaluate the safety and immunogenicity of two types of Recombinant Novel Corona Virus Vaccine (Adenovirus type 5 vector) in population aged 6-17 years who have been previously immunized with 2 doses of inactivated COVID-19 vaccine. This is to evaluate the safety and immunogenicity of different heterologous prime-boost regimen in this population.

Read the detailed description

Participants will be randomized into two age groups: children aged 6-12 years and adolescents aged 13-17 years. Subjects who have previously been immunized with 2 doses of inactivated COVID-19 vaccine will be randomized into the booster dose groups to receive either 1 dose of 0.1ml inhaled Ad5- nCoV-IH, 1 dose of 0.3ml intramuscular Ad5-nCoV-IM or 1 dose of 0.5ml intramuscular inactivated vaccine ICV as activecomparator in a ratio of 3:1:1. Participants who have not received any COVID-19 vaccine previously will be randomized into 2 primary dose age groups: children aged 6-12 years and adolescents aged 13-17 years to receive 2 doses of 0.1ml inhaled Ad5-nCoVIH. The first 5 subjects of each age group will enter the sentinel group to receive Ad5-nCoV-IH and monitor for safety before the rest of the enrollment process.

Conditions
COVID-19
Being tested
1 Nebulized inhalation for booster groups, 2 Nebulized inhalation for booster groups, 3 Nebulized inhalation for booster groups, 4 Nebulized inhalation for booster groups, 5 Intramuscular injection for booster groups
Keywords
COVID-19, Vaccine, Ad5, Heterologous, Safety, Immunogenicity, 6-17 years, Inactivated COVID-19 vaccine, boost
Medical subject headings
COVID-19, Alzheimer Disease 5

What participants receive

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

  • 1 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 2 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 3 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 4 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 5 Intramuscular injection for booster groupsBiological

    Also called Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

    Ad5-nCoV-IM, 1 dose 0.3ml

  • 6 Intramuscular injection for booster groupsBiological

    Also called Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

    Ad5-nCoV-IM, 1 dose 0.3ml

  • 7 Intramuscular injection for booster groupsBiological

    Also called Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

    Ad5-nCoV-IM, 1 dose 0.3ml

  • 8 Intramuscular injection for booster groupsBiological

    Also called Inactivated COVID-19 Vaccine

    ICV, 1 dose 0.5ml

  • 9 Intramuscular injection for booster groupsBiological

    Also called Inactivated COVID-19 Vaccine

    ICV, 1 dose 0.5ml

  • 10 Intramuscular injection for booster groupsBiological

    Also called Inactivated COVID-19 Vaccine

    1 dose 0.5ml

  • 11 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 12 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 13 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 14 Nebulized inhalation for booster groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 1 dose 0.1ml

  • 15 Intramuscular injection for booster groupsBiological

    Also called Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

    Ad5-nCoV-IM, 1 dose 0.3ml

  • 16 Intramuscular injection for booster groupsBiological

    Also called Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

    Ad5-nCoV-IM, 1 dose 0.3ml

  • 17 Intramuscular injection for booster groupsBiological

    Also called Recombinant Corona Virus Vaccine (Adenovirus Type 5 Vector)

    Ad5-nCoV-IM, 1 dose 0.3ml

  • 18 Intramuscular injection for booster groupsBiological

    Also called Inactivated COVID-19 Vaccine

    ICV, 1 dose 0.5ml

  • 19 Intramuscular injection for booster groupsBiological

    Also called Inactivated COVID-19 Vaccine

    ICV, 1 dose 0.5ml

  • 20 Intramuscular injection for booster groupsBiological

    Also called Inactivated COVID-19 Vaccine

    ICV, 1 dose 0.5ml

  • 21 Nebulized inhalation for primary groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 2 doses 0.1ml

  • 22 Nebulized inhalation for primary groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 2 doses 0.1ml

  • 23 Nebulized inhalation for primary groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 2 doses 0.1ml

  • 24 Nebulized inhalation for primary groupsBiological

    Also called Recombinant COVID-19 Vaccine for Inhalation

    Ad5-nCoV-IH, 2 doses 0.1ml

Study groups in NCT05330871
Study groupRoleWhat they receive
1. Adolescent booster sentinel groupExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 1 Nebulized inhalation for booster groups
2. Adolescent booster safety group to receive Ad5-nCoV-IHExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 2 Nebulized inhalation for booster groups
3. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IHExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 3 Nebulized inhalation for booster groups
4. Adolescent booster cellular immunity group to receive Ad5-nCoV-IHExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 4 Nebulized inhalation for booster groups
5. Adolescent booster safety group to receive Ad5-nCoV-IMExperimental1 dose of 0.3ml Ad5-nCoV-IM
Receives: Biological: 5 Intramuscular injection for booster groups
6. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IMExperimental1 dose of 0.3ml Ad5-nCoV-IM
Receives: Biological: 6 Intramuscular injection for booster groups
7. Adolescent booster cellular immunity group to receive Ad5-nCoV-IMExperimental1 dose of 0.3ml Ad5-nCoV-IM
Receives: Biological: 7 Intramuscular injection for booster groups
8. Adolesent booster safety group to receive ICVActive comparator1 dose of 0.5ml ICV
Receives: Biological: 8 Intramuscular injection for booster groups
9. Adolescent booster immunopersistency group to receive ICVActive comparator1 dose of 0.5ml ICV
Receives: Biological: 9 Intramuscular injection for booster groups
10. Adolescent booster cellular immunity group to receive ICVActive comparator1 dose of 0.5ml ICV
Receives: Biological: 10 Intramuscular injection for booster groups
11. Children booster sentinel group to receive Ad5-nCoV-IHExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 11 Nebulized inhalation for booster groups
12. Children booster safety group to receive Ad5-nCoV-IHExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 12 Nebulized inhalation for booster groups
13. Children booster immuno-persistency group to receive Ad5-nCoV-IHExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 13 Nebulized inhalation for booster groups
14. Children booster cellular immunity group to receive Ad5-nCoV-IHExperimental1 dose of 0.1ml Ad5-nCoV-IH
Receives: Biological: 14 Nebulized inhalation for booster groups
15. Children booster safety group to receive Ad5-nCoV-IMExperimental1 dose of 0.3ml Ad5-nCoV-IM
Receives: Biological: 15 Intramuscular injection for booster groups
16. Children booster immuno-persistency group to receive Ad5-nCoV-IMExperimental1 dose of 0.3ml Ad5-nCoV-IM
Receives: Biological: 16 Intramuscular injection for booster groups
17. Children booster cellular immunity group to receive Ad5-nCoV-IMExperimental1 dose of 0.3ml Ad5-nCoV-IM
Receives: Biological: 17 Intramuscular injection for booster groups
18. Children booster safety group to receive ICVActive comparator1 dose of 0.5ml ICV
Receives: Biological: 18 Intramuscular injection for booster groups
19. Children booster immuno-persistency group to receive ICVActive comparator1 dose of 0.5ml ICV
Receives: Biological: 19 Intramuscular injection for booster groups
20. Children booster cellular immunity group to receive ICVActive comparator1 dose of 0.5ml ICV
Receives: Biological: 20 Intramuscular injection for booster groups
21. Adolescent primary sentinel groupExperimental2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
Receives: Biological: 21 Nebulized inhalation for primary groups
22. Adolescent primary groupExperimental2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
Receives: Biological: 22 Nebulized inhalation for primary groups
23. Children primary sentinel groupExperimental2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
Receives: Biological: 23 Nebulized inhalation for primary groups
24. Children primary groupExperimental2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
Receives: Biological: 24 Nebulized inhalation for primary groups

What is being measured

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

  1. Immunogenicity of anti SARS-CoV-2 neutralizing antibody

    GMT of anti SARS-CoV-2 neutralizing antibody

    Measured: 28 days post vaccination

  2. Incidence of adverse reaction (AR)

    Incidence of adverse reaction (AR)

    Measured: 0-14 days post each vaccination

Secondary outcomes (15)

  1. Immunogenicity of anti SARS-CoV-2 S protein IgG antibody

    Seroconversion rate of anti SARS-CoV-2 S protein IgG antibody (4 times fold increase)

    Measured: 28 days post vaccination

  2. Immunogenicity of anti SARS-CoV-2 S protein IgG antibody

    GMC of anti SARS-CoV-2 S protein IgG antibody

    Measured: 28 days post vaccination

  3. Immunogenicity of anti SARS-CoV-2 S protein IgG antibody

    GMI of anti SARS-CoV-2 S protein IgG antibody

    Measured: 28 days post vaccination

  4. Immunogenicity of anti Ad5 vector antibody

    Stratified analysis of baseline level of anti Ad5 vector antibody

    Measured: Day 0 before vaccination

  5. Immunogenicity of anti SARS-CoV-2 neutralizing antibody

    Seroconversion rate of anti SARS-CoV-2 neutralizing antibody

    Measured: Post vaccination

  6. Immunogenicity of anti SARS-CoV-2 neutralizing antibody

    GMI of anti SARS-CoV-2 neutralizing antibody

    Measured: Post vaccination

  7. Incidence of adverse event/adverse reaction

    Incidence of AE/AR

    Measured: 30 minutes post each vaccination

  8. Incidence of adverse event/adverse reaction

    Incidence of AE/AR

    Measured: 0-28 days post each vaccination

  9. Incidence of Serious Adverse Event

    Incidence of SAE

    Measured: First dose vaccination to 12 months post last vaccination]

  10. Changes in laboratory indicators in sentinel groups and safety groups

    Changes in WBC counts

    Measured: 4 days post each vaccination

  11. Changes in laboratory indicators in sentinel groups and safety groups

    Changes in lymphocytes counts

    Measured: 4 days post each vaccination

  12. Changes in laboratory indicators in sentinel groups and safety groups

    Changes in platelet counts

    Measured: 4 days post each vaccination

  13. Immuno-persistency of anti SARS-CoV-2 S protein IgG antibody

    GMC of anti SARS-CoV-2 S protein IgG antibody in immuno-persistency and primary groups

    Measured: 3 months, 6 months and 12 months post vaccination

  14. Immuno-persistency of anti SARS-CoV-2 S protein IgG antibody

    Seroconversion rate of anti SARS-CoV-2 S protein IgG antibody in immuno-persistency and primary groups

    Measured: 6 months and 12 months post vaccination

  15. Immuno-persistency of anti SARS-CoV-2 S protein IgG antibody

    GMI of anti SARS-CoV-2 S protein IgG antibody in immuno-persistency and primary groups

    Measured: 6 months and 12 months post vaccination

Timeline

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

  1. First posted15 Apr 2022
  2. Study start17 Apr 2022
  3. Primary completion30 Jun 2022
  4. Study completion30 May 2023 (estimated)

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05330871
Sponsor's protocol ID
CT-Ad5-nCoV-IH-#
Status last verified
Mar 2023
First submitted
14 Apr 2022
Last updated
13 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huang T, Zhang S, Dai DF, Wang BS, Zhuang L, Huang HT, Wang ZF, Zhao JS, Li QP, Wu SP, Wang X, Zhang WD, Zhao ZH, Li H, Zhang YP, Yang XL, Jiang XY, Gou JB, Hou LH, Gao LD, Feng ZC. Safety and immunogenicity of heterologous boosting with orally aerosolised or intramuscular Ad5-nCoV vaccine and homologous boosting with inactivated vaccines (BBIBP-CorV or CoronaVac) in children and adolescents: a randomised, open-label, parallel-controlled, non-inferiority, single-centre study. Lancet Respir Med. 2023 Aug;11(8):698-708. doi: 10.1016/S2213-2600(23)00129-7. Epub 2023 May 17.

    PubMed 37209700

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1 Nebulized inhalation for booster groups, 2 Nebulized inhalation for booster groups and 3 Nebulized inhalation for booster groups in people with COVID-19, run by Seventh Medical Center of PLA General Hospital at 1 site in China.

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 30 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: status not confirmed, as of the sponsor's last update on 13 Apr 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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?

Immunogenicity of anti SARS-CoV-2 neutralizing antibody (time frame: 28 days post vaccination). 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 NCT05330871, 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 13 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in