Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.
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
1 other identifier
interventional
410
1 country
1
Brief 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 COVID-19 vaccine. This is to evaluate the safety and immunogenicity of different heterologous prime-boost regimen in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Apr 2022
Typical duration for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Start
First participant enrolled
April 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedApril 13, 2023
March 1, 2023
2 months
April 14, 2022
April 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (15)
Immunogenicity of anti SARS-CoV-2 S protein IgG antibody
28 days post vaccination
Immunogenicity of anti SARS-CoV-2 S protein IgG antibody
28 days post vaccination
Immunogenicity of anti SARS-CoV-2 S protein IgG antibody
28 days post vaccination
Immunogenicity of anti Ad5 vector antibody
Day 0 before vaccination
Immunogenicity of anti SARS-CoV-2 neutralizing antibody
Post vaccination
- +10 more secondary outcomes
Study Arms (24)
1. Adolescent booster sentinel group
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
2. Adolescent booster safety group to receive Ad5-nCoV-IH
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
3. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IH
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
4. Adolescent booster cellular immunity group to receive Ad5-nCoV-IH
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
5. Adolescent booster safety group to receive Ad5-nCoV-IM
EXPERIMENTAL1 dose of 0.3ml Ad5-nCoV-IM
6. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IM
EXPERIMENTAL1 dose of 0.3ml Ad5-nCoV-IM
7. Adolescent booster cellular immunity group to receive Ad5-nCoV-IM
EXPERIMENTAL1 dose of 0.3ml Ad5-nCoV-IM
8. Adolesent booster safety group to receive ICV
ACTIVE COMPARATOR1 dose of 0.5ml ICV
9. Adolescent booster immunopersistency group to receive ICV
ACTIVE COMPARATOR1 dose of 0.5ml ICV
10. Adolescent booster cellular immunity group to receive ICV
ACTIVE COMPARATOR1 dose of 0.5ml ICV
11. Children booster sentinel group to receive Ad5-nCoV-IH
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
12. Children booster safety group to receive Ad5-nCoV-IH
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
13. Children booster immuno-persistency group to receive Ad5-nCoV-IH
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
14. Children booster cellular immunity group to receive Ad5-nCoV-IH
EXPERIMENTAL1 dose of 0.1ml Ad5-nCoV-IH
15. Children booster safety group to receive Ad5-nCoV-IM
EXPERIMENTAL1 dose of 0.3ml Ad5-nCoV-IM
16. Children booster immuno-persistency group to receive Ad5-nCoV-IM
EXPERIMENTAL1 dose of 0.3ml Ad5-nCoV-IM
17. Children booster cellular immunity group to receive Ad5-nCoV-IM
EXPERIMENTAL1 dose of 0.3ml Ad5-nCoV-IM
18. Children booster safety group to receive ICV
ACTIVE COMPARATOR1 dose of 0.5ml ICV
19. Children booster immuno-persistency group to receive ICV
ACTIVE COMPARATOR1 dose of 0.5ml ICV
20. Children booster cellular immunity group to receive ICV
ACTIVE COMPARATOR1 dose of 0.5ml ICV
21. Adolescent primary sentinel group
EXPERIMENTAL2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
22. Adolescent primary group
EXPERIMENTAL2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
23. Children primary sentinel group
EXPERIMENTAL2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
24. Children primary group
EXPERIMENTAL2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
Interventions
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IM, 1 dose 0.3ml
Ad5-nCoV-IM, 1 dose 0.3ml
Ad5-nCoV-IM, 1 dose 0.3ml
ICV, 1 dose 0.5ml
ICV, 1 dose 0.5ml
1 dose 0.5ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IM, 1 dose 0.3ml
Ad5-nCoV-IM, 1 dose 0.3ml
Ad5-nCoV-IM, 1 dose 0.3ml
ICV, 1 dose 0.5ml
ICV, 1 dose 0.5ml
ICV, 1 dose 0.5ml
Ad5-nCoV-IH, 2 doses 0.1ml
Ad5-nCoV-IH, 2 doses 0.1ml
Ad5-nCoV-IH, 2 doses 0.1ml
Ad5-nCoV-IH, 2 doses 0.1ml
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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#.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province
Xiangxi, Hunan, 416199, China
Related Publications (1)
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.
PMID: 37209700DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chen Dong
Seventh Medical Center of PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 15, 2022
Study Start
April 17, 2022
Primary Completion
June 30, 2022
Study Completion
May 30, 2023
Last Updated
April 13, 2023
Record last verified: 2023-03