- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05330871
Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.
April 12, 2023 updated by: Seventh Medical Center of PLA General Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
- Biological: 1 Nebulized inhalation for booster groups
- Biological: 2 Nebulized inhalation for booster groups
- Biological: 3 Nebulized inhalation for booster groups
- Biological: 4 Nebulized inhalation for booster groups
- Biological: 5 Intramuscular injection for booster groups
- Biological: 6 Intramuscular injection for booster groups
- Biological: 7 Intramuscular injection for booster groups
- Biological: 8 Intramuscular injection for booster groups
- Biological: 9 Intramuscular injection for booster groups
- Biological: 10 Intramuscular injection for booster groups
- Biological: 11 Nebulized inhalation for booster groups
- Biological: 12 Nebulized inhalation for booster groups
- Biological: 13 Nebulized inhalation for booster groups
- Biological: 14 Nebulized inhalation for booster groups
- Biological: 15 Intramuscular injection for booster groups
- Biological: 16 Intramuscular injection for booster groups
- Biological: 17 Intramuscular injection for booster groups
- Biological: 18 Intramuscular injection for booster groups
- Biological: 19 Intramuscular injection for booster groups
- Biological: 20 Intramuscular injection for booster groups
- Biological: 21 Nebulized inhalation for primary groups
- Biological: 22 Nebulized inhalation for primary groups
- Biological: 23 Nebulized inhalation for primary groups
- Biological: 24 Nebulized inhalation for primary groups
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.
Study Type
Interventional
Enrollment (Actual)
410
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sheng Zhang, doctor
- Phone Number: +86(10) 13810627797
- Email: ahswzs@sina.com
Study Locations
-
-
Hunan
-
Xiangxi, Hunan, China, 416199
- CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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).
Exclusion criteria for second dose:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1. Adolescent booster sentinel group
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 2. Adolescent booster safety group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 3. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 4. Adolescent booster cellular immunity group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 5. Adolescent booster safety group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
|
Ad5-nCoV-IM, 1 dose 0.3ml
Other Names:
|
Experimental: 6. Adolescent booster immuno-persistency group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
|
Ad5-nCoV-IM, 1 dose 0.3ml
Other Names:
|
Experimental: 7. Adolescent booster cellular immunity group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
|
Ad5-nCoV-IM, 1 dose 0.3ml
Other Names:
|
Active Comparator: 8. Adolesent booster safety group to receive ICV
1 dose of 0.5ml ICV
|
ICV, 1 dose 0.5ml
Other Names:
|
Active Comparator: 9. Adolescent booster immunopersistency group to receive ICV
1 dose of 0.5ml ICV
|
ICV, 1 dose 0.5ml
Other Names:
|
Active Comparator: 10. Adolescent booster cellular immunity group to receive ICV
1 dose of 0.5ml ICV
|
1 dose 0.5ml
Other Names:
|
Experimental: 11. Children booster sentinel group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 12. Children booster safety group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 13. Children booster immuno-persistency group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 14. Children booster cellular immunity group to receive Ad5-nCoV-IH
1 dose of 0.1ml Ad5-nCoV-IH
|
Ad5-nCoV-IH, 1 dose 0.1ml
Other Names:
|
Experimental: 15. Children booster safety group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
|
Ad5-nCoV-IM, 1 dose 0.3ml
Other Names:
|
Experimental: 16. Children booster immuno-persistency group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
|
Ad5-nCoV-IM, 1 dose 0.3ml
Other Names:
|
Experimental: 17. Children booster cellular immunity group to receive Ad5-nCoV-IM
1 dose of 0.3ml Ad5-nCoV-IM
|
Ad5-nCoV-IM, 1 dose 0.3ml
Other Names:
|
Active Comparator: 18. Children booster safety group to receive ICV
1 dose of 0.5ml ICV
|
ICV, 1 dose 0.5ml
Other Names:
|
Active Comparator: 19. Children booster immuno-persistency group to receive ICV
1 dose of 0.5ml ICV
|
ICV, 1 dose 0.5ml
Other Names:
|
Active Comparator: 20. Children booster cellular immunity group to receive ICV
1 dose of 0.5ml ICV
|
ICV, 1 dose 0.5ml
Other Names:
|
Experimental: 21. Adolescent primary sentinel group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
|
Ad5-nCoV-IH, 2 doses 0.1ml
Other Names:
|
Experimental: 22. Adolescent primary group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
|
Ad5-nCoV-IH, 2 doses 0.1ml
Other Names:
|
Experimental: 23. Children primary sentinel group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
|
Ad5-nCoV-IH, 2 doses 0.1ml
Other Names:
|
Experimental: 24. Children primary group
2 doses of 0.1ml Ad5-nCoV-IH, 56 days interval
|
Ad5-nCoV-IH, 2 doses 0.1ml
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of anti SARS-CoV-2 neutralizing antibody
Time Frame: 28 days post vaccination
|
GMT of anti SARS-CoV-2 neutralizing antibody
|
28 days post vaccination
|
Incidence of adverse reaction (AR)
Time Frame: 0-14 days post each vaccination
|
Incidence of adverse reaction (AR)
|
0-14 days post each vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of anti SARS-CoV-2 S protein IgG antibody
Time Frame: 28 days post vaccination
|
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
Time Frame: 28 days post vaccination
|
GMC of anti SARS-CoV-2 S protein IgG antibody
|
28 days post vaccination
|
Immunogenicity of anti SARS-CoV-2 S protein IgG antibody
Time Frame: 28 days post vaccination
|
GMI of anti SARS-CoV-2 S protein IgG antibody
|
28 days post vaccination
|
Immunogenicity of anti Ad5 vector antibody
Time Frame: Day 0 before vaccination
|
Stratified analysis of baseline level of anti Ad5 vector antibody
|
Day 0 before vaccination
|
Immunogenicity of anti SARS-CoV-2 neutralizing antibody
Time Frame: Post vaccination
|
Seroconversion rate of anti SARS-CoV-2 neutralizing antibody
|
Post vaccination
|
Immunogenicity of anti SARS-CoV-2 neutralizing antibody
Time Frame: Post vaccination
|
GMI of anti SARS-CoV-2 neutralizing antibody
|
Post vaccination
|
Incidence of adverse event/adverse reaction
Time Frame: 30 minutes post each vaccination
|
Incidence of AE/AR
|
30 minutes post each vaccination
|
Incidence of adverse event/adverse reaction
Time Frame: 0-28 days post each vaccination
|
Incidence of AE/AR
|
0-28 days post each vaccination
|
Incidence of Serious Adverse Event
Time Frame: First dose vaccination to 12 months post last vaccination]
|
Incidence of SAE
|
First dose vaccination to 12 months post last vaccination]
|
Changes in laboratory indicators in sentinel groups and safety groups
Time Frame: 4 days post each vaccination
|
Changes in WBC counts
|
4 days post each vaccination
|
Changes in laboratory indicators in sentinel groups and safety groups
Time Frame: 4 days post each vaccination
|
Changes in lymphocytes counts
|
4 days post each vaccination
|
Changes in laboratory indicators in sentinel groups and safety groups
Time Frame: 4 days post each vaccination
|
Changes in platelet counts
|
4 days post each vaccination
|
Immuno-persistency of anti SARS-CoV-2 S protein IgG antibody
Time Frame: 3 months, 6 months and 12 months post vaccination
|
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
Time Frame: 6 months and 12 months post vaccination
|
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
Time Frame: 6 months and 12 months post vaccination
|
GMI of anti SARS-CoV-2 S protein IgG antibody in immuno-persistency and primary groups
|
6 months and 12 months post vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Chen Dong, Seventh Medical Center of PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Anticipated)
May 30, 2023
Study Registration Dates
First Submitted
April 14, 2022
First Submitted That Met QC Criteria
April 14, 2022
First Posted (Actual)
April 15, 2022
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT-Ad5-nCoV-IH-#
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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