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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
410
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
Ad5-nCoV-IH, 1 dose 0.1ml
CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province
Xiangxi, Hunan, China
Immunogenicity of anti SARS-CoV-2 neutralizing antibody
GMT of anti SARS-CoV-2 neutralizing antibody
Time frame: 28 days post vaccination
Incidence of adverse reaction (AR)
Incidence of adverse reaction (AR)
Time frame: 0-14 days post each vaccination
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)
Time frame: 28 days post vaccination
Immunogenicity of anti SARS-CoV-2 S protein IgG antibody
GMC of anti SARS-CoV-2 S protein IgG antibody
Time frame: 28 days post vaccination
Immunogenicity of anti SARS-CoV-2 S protein IgG antibody
GMI of anti SARS-CoV-2 S protein IgG antibody
Time frame: 28 days post vaccination
Immunogenicity of anti Ad5 vector antibody
Stratified analysis of baseline level of anti Ad5 vector antibody
Time frame: Day 0 before vaccination
Immunogenicity of anti SARS-CoV-2 neutralizing antibody
Seroconversion rate of anti SARS-CoV-2 neutralizing antibody
Time frame: Post vaccination
Immunogenicity of anti SARS-CoV-2 neutralizing antibody
GMI of anti SARS-CoV-2 neutralizing antibody
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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
Time frame: Post vaccination
Incidence of adverse event/adverse reaction
Incidence of AE/AR
Time frame: 30 minutes post each vaccination
Incidence of adverse event/adverse reaction
Incidence of AE/AR
Time frame: 0-28 days post each vaccination
Incidence of Serious Adverse Event
Incidence of SAE
Time frame: First dose vaccination to 12 months post last vaccination]
Changes in laboratory indicators in sentinel groups and safety groups
Changes in WBC counts
Time frame: 4 days post each vaccination
Changes in laboratory indicators in sentinel groups and safety groups
Changes in lymphocytes counts
Time frame: 4 days post each vaccination
Changes in laboratory indicators in sentinel groups and safety groups
Changes in platelet counts
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months and 12 months post vaccination