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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Adolescent booster sentinel group | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
|
| 2. Adolescent booster safety group to receive Ad5-nCoV-IH | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
|
| 3. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IH | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
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| 4. Adolescent booster cellular immunity group to receive Ad5-nCoV-IH | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
|
| 5. Adolescent booster safety group to receive Ad5-nCoV-IM | Experimental | 1 dose of 0.3ml Ad5-nCoV-IM |
|
| 6. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of anti SARS-CoV-2 neutralizing antibody | GMT of anti SARS-CoV-2 neutralizing antibody | 28 days post vaccination |
| Incidence of adverse reaction (AR) | Incidence of adverse reaction (AR) | 0-14 days post each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days post vaccination |
| Immunogenicity of anti SARS-CoV-2 S protein IgG antibody |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for second dose:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Dong | Seventh Medical Center of PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province | Xiangxi | Hunan | 416199 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37209700 | Derived | 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. |
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| Experimental |
1 dose of 0.3ml Ad5-nCoV-IM |
|
| 7. Adolescent booster cellular immunity group to receive Ad5-nCoV-IM | Experimental | 1 dose of 0.3ml Ad5-nCoV-IM |
|
| 8. Adolesent booster safety group to receive ICV | Active Comparator | 1 dose of 0.5ml ICV |
|
| 9. Adolescent booster immunopersistency group to receive ICV | Active Comparator | 1 dose of 0.5ml ICV |
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| 10. Adolescent booster cellular immunity group to receive ICV | Active Comparator | 1 dose of 0.5ml ICV |
|
| 11. Children booster sentinel group to receive Ad5-nCoV-IH | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
|
| 12. Children booster safety group to receive Ad5-nCoV-IH | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
|
| 13. Children booster immuno-persistency group to receive Ad5-nCoV-IH | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
|
| 14. Children booster cellular immunity group to receive Ad5-nCoV-IH | Experimental | 1 dose of 0.1ml Ad5-nCoV-IH |
|
| 15. Children booster safety group to receive Ad5-nCoV-IM | Experimental | 1 dose of 0.3ml Ad5-nCoV-IM |
|
| 16. Children booster immuno-persistency group to receive Ad5-nCoV-IM | Experimental | 1 dose of 0.3ml Ad5-nCoV-IM |
|
| 17. Children booster cellular immunity group to receive Ad5-nCoV-IM | Experimental | 1 dose of 0.3ml Ad5-nCoV-IM |
|
| 18. Children booster safety group to receive ICV | Active Comparator | 1 dose of 0.5ml ICV |
|
| 19. Children booster immuno-persistency group to receive ICV | Active Comparator | 1 dose of 0.5ml ICV |
|
| 20. Children booster cellular immunity group to receive ICV | Active Comparator | 1 dose of 0.5ml ICV |
|
| 21. Adolescent primary sentinel group | Experimental | 2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval |
|
| 22. Adolescent primary group | Experimental | 2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval |
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| 23. Children primary sentinel group | Experimental | 2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval |
|
| 24. Children primary group | Experimental | 2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval |
|
| 2 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
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| 3 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
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| 4 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
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| 5 Intramuscular injection for booster groups | Biological | Ad5-nCoV-IM, 1 dose 0.3ml |
|
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| 6 Intramuscular injection for booster groups | Biological | Ad5-nCoV-IM, 1 dose 0.3ml |
|
|
| 7 Intramuscular injection for booster groups | Biological | Ad5-nCoV-IM, 1 dose 0.3ml |
|
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| 8 Intramuscular injection for booster groups | Biological | ICV, 1 dose 0.5ml |
|
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| 9 Intramuscular injection for booster groups | Biological | ICV, 1 dose 0.5ml |
|
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| 10 Intramuscular injection for booster groups | Biological | 1 dose 0.5ml |
|
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| 11 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
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| 12 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
|
| 13 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
|
| 14 Nebulized inhalation for booster groups | Biological | Ad5-nCoV-IH, 1 dose 0.1ml |
|
|
| 15 Intramuscular injection for booster groups | Biological | Ad5-nCoV-IM, 1 dose 0.3ml |
|
|
| 16 Intramuscular injection for booster groups | Biological | Ad5-nCoV-IM, 1 dose 0.3ml |
|
|
| 17 Intramuscular injection for booster groups | Biological | Ad5-nCoV-IM, 1 dose 0.3ml |
|
|
| 18 Intramuscular injection for booster groups | Biological | ICV, 1 dose 0.5ml |
|
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| 19 Intramuscular injection for booster groups | Biological | ICV, 1 dose 0.5ml |
|
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| 20 Intramuscular injection for booster groups | Biological | ICV, 1 dose 0.5ml |
|
|
| 21 Nebulized inhalation for primary groups | Biological | Ad5-nCoV-IH, 2 doses 0.1ml |
|
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| 22 Nebulized inhalation for primary groups | Biological | Ad5-nCoV-IH, 2 doses 0.1ml |
|
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| 23 Nebulized inhalation for primary groups | Biological | Ad5-nCoV-IH, 2 doses 0.1ml |
|
|
| 24 Nebulized inhalation for primary groups | Biological | Ad5-nCoV-IH, 2 doses 0.1ml |
|
|
GMC of anti SARS-CoV-2 S protein IgG antibody
| 28 days post vaccination |
| Immunogenicity of anti SARS-CoV-2 S protein IgG antibody | GMI of anti SARS-CoV-2 S protein IgG antibody | 28 days post vaccination |
| Immunogenicity of anti Ad5 vector antibody | Stratified analysis of baseline level of anti Ad5 vector antibody | Day 0 before vaccination |
| Immunogenicity of anti SARS-CoV-2 neutralizing antibody | Seroconversion rate of anti SARS-CoV-2 neutralizing antibody | Post vaccination |
| Immunogenicity of anti SARS-CoV-2 neutralizing antibody | GMI of anti SARS-CoV-2 neutralizing antibody | Post vaccination |
| Incidence of adverse event/adverse reaction | Incidence of AE/AR | 30 minutes post each vaccination |
| Incidence of adverse event/adverse reaction | Incidence of AE/AR | 0-28 days post each vaccination |
| Incidence of Serious Adverse Event | Incidence of SAE | First dose vaccination to 12 months post last vaccination] |
| Changes in laboratory indicators in sentinel groups and safety groups | Changes in WBC counts | 4 days post each vaccination |
| Changes in laboratory indicators in sentinel groups and safety groups | Changes in lymphocytes counts | 4 days post each vaccination |
| Changes in laboratory indicators in sentinel groups and safety groups | Changes in platelet counts | 4 days post each vaccination |
| 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 | 3 months, 6 months and 12 months post vaccination |
| 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 | 6 months and 12 months post vaccination |
| 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 | 6 months and 12 months post vaccination |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| C566578 | Alzheimer Disease 5 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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