COVID-19
Conditions
Keywords
COVID-19, Vaccine, Ad5, Heterologous, Safety, Immunogenicity, 6-17 years, Inactivated COVID-19 vaccine, boost
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.
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.
Interventions
BIOLOGICAL1 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL2 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL3 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL4 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL5 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL6 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL7 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL8 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
BIOLOGICAL9 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
BIOLOGICAL10 Intramuscular injection for booster groups
1 dose 0.5ml
BIOLOGICAL11 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL12 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL13 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL14 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL15 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL16 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL17 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL18 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
BIOLOGICAL19 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
BIOLOGICAL20 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
BIOLOGICAL21 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
BIOLOGICAL22 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
BIOLOGICAL23 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
BIOLOGICAL24 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
Sponsors
Seventh Medical Center of PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of anti SARS-CoV-2 neutralizing antibody | 28 days post vaccination | GMT of anti SARS-CoV-2 neutralizing antibody |
| Incidence of adverse reaction (AR) | 0-14 days post each vaccination | Incidence of adverse reaction (AR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Event | First dose vaccination to 12 months post last vaccination] | Incidence of SAE |
| Changes in laboratory indicators in sentinel groups and safety groups | 4 days post each vaccination | Changes in WBC counts |
| Immunogenicity of anti SARS-CoV-2 neutralizing antibody | Post vaccination | Seroconversion rate of anti SARS-CoV-2 neutralizing antibody |
| Immunogenicity of anti Ad5 vector antibody | Day 0 before vaccination | Stratified analysis of baseline level of anti Ad5 vector antibody |
| Immuno-persistency of anti SARS-CoV-2 S protein IgG antibody | 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 |
| Immunogenicity of anti SARS-CoV-2 S protein IgG antibody | 28 days post vaccination | Seroconversion rate of anti SARS-CoV-2 S protein IgG antibody (4 times fold increase) |
| Incidence of adverse event/adverse reaction | 30 minutes post each vaccination | Incidence of AE/AR |
Countries
China
Outcome results
None listed