Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.
NCT ID: NCT05330871
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
410 participants
INTERVENTIONAL
2022-04-17
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1. Adolescent booster sentinel group
1 dose of 0.1ml Ad5-nCoV-IH
1 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
2. Adolescent booster safety group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
2 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
3. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
3 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
4. Adolescent booster cellular immunity group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
4 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
5. Adolescent booster safety group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
5 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
6. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
6 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
7. Adolescent booster cellular immunity group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
7 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
8. Adolesent booster safety group to receive ICV
1 dose of 0.5ml ICV
8 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
9. Adolescent booster immunopersistency group to receive ICV
1 dose of 0.5ml ICV
9 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
10. Adolescent booster cellular immunity group to receive ICV
1 dose of 0.5ml ICV
10 Intramuscular injection for booster groups
1 dose 0.5ml
11. Children booster sentinel group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
11 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
12. Children booster safety group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
12 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
13. Children booster immuno-persistency group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
13 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
14. Children booster cellular immunity group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
14 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
15. Children booster safety group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
15 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
16. Children booster immuno-persistency group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
16 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
17. Children booster cellular immunity group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
17 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
18. Children booster safety group to receive ICV
1 dose of 0.5ml ICV
18 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
19. Children booster immuno-persistency group to receive ICV
1 dose of 0.5ml ICV
19 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
20. Children booster cellular immunity group to receive ICV
1 dose of 0.5ml ICV
20 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
21. Adolescent primary sentinel group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
21 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
22. Adolescent primary group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
22 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
23. Children primary sentinel group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
23 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
24. Children primary group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
24 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
Interventions
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1 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
2 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
3 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
4 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
5 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
6 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
7 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
8 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
9 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
10 Intramuscular injection for booster groups
1 dose 0.5ml
11 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
12 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
13 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
14 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
15 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
16 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
17 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
18 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
19 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
20 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
21 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
22 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
23 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
24 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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#.
* 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).
* Vaccine related SAE post first dose vaccination.
* Serious allergic reactions post first dose vaccination.
* Other reasons in the opinion of the investigator.
6 Years
17 Years
ALL
Yes
Sponsors
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Seventh Medical Center of PLA General Hospital
OTHER
Responsible Party
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Principal Investigators
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Chen Dong
Role: STUDY_CHAIR
Seventh Medical Center of PLA General Hospital
Locations
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CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province
Xiangxi, Hunan, China
Countries
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References
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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.
Other Identifiers
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CT-Ad5-nCoV-IH-#
Identifier Type: -
Identifier Source: org_study_id
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