Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05330871
• Other study ID #: CT-Ad5-nCoV-IH-#
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 17, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: March 2023
• Source: Seventh Medical Center of PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 410
• Est. completion date: May 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• 1 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 2 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 3 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 4 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 5 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
• 6 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
• 7 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
• 8 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
• 9 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
• 10 Intramuscular injection for booster groups
1 dose 0.5ml
• 11 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 12 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 13 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 14 Nebulized inhalation for booster groups
Ad5-nCoV-IH, 1 dose 0.1ml
• 15 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
• 16 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
• 17 Intramuscular injection for booster groups
Ad5-nCoV-IM, 1 dose 0.3ml
• 18 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
• 19 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
• 20 Intramuscular injection for booster groups
ICV, 1 dose 0.5ml
• 21 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
• 22 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
• 23 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml
• 24 Nebulized inhalation for primary groups
Ad5-nCoV-IH, 2 doses 0.1ml

Locations

Country	Name	City	State
China	CDC of of Luxi County, Xiangxi Tujia and Miao Autonomous Prefecture, Hunan Province	Xiangxi	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Seventh Medical Center of PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of anti SARS-CoV-2 neutralizing antibody	GMT of anti SARS-CoV-2 neutralizing antibody	28 days post vaccination
Primary	Incidence of adverse reaction (AR)	Incidence of adverse reaction (AR)	0-14 days post each vaccination
Secondary	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
Secondary	Immunogenicity of anti SARS-CoV-2 S protein IgG antibody	GMC of anti SARS-CoV-2 S protein IgG antibody	28 days post vaccination
Secondary	Immunogenicity of anti SARS-CoV-2 S protein IgG antibody	GMI of anti SARS-CoV-2 S protein IgG antibody	28 days post vaccination
Secondary	Immunogenicity of anti Ad5 vector antibody	Stratified analysis of baseline level of anti Ad5 vector antibody	Day 0 before vaccination
Secondary	Immunogenicity of anti SARS-CoV-2 neutralizing antibody	Seroconversion rate of anti SARS-CoV-2 neutralizing antibody	Post vaccination
Secondary	Immunogenicity of anti SARS-CoV-2 neutralizing antibody	GMI of anti SARS-CoV-2 neutralizing antibody	Post vaccination
Secondary	Incidence of adverse event/adverse reaction	Incidence of AE/AR	30 minutes post each vaccination
Secondary	Incidence of adverse event/adverse reaction	Incidence of AE/AR	0-28 days post each vaccination
Secondary	Incidence of Serious Adverse Event	Incidence of SAE	First dose vaccination to 12 months post last vaccination]
Secondary	Changes in laboratory indicators in sentinel groups and safety groups	Changes in WBC counts	4 days post each vaccination
Secondary	Changes in laboratory indicators in sentinel groups and safety groups	Changes in lymphocytes counts	4 days post each vaccination
Secondary	Changes in laboratory indicators in sentinel groups and safety groups	Changes in platelet counts	4 days post each vaccination
Secondary	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
Secondary	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
Secondary	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