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The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine

Primary Purpose

Adenovirus Type-5 Vectored COVID-19 Vaccine

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Adenovirus Type-5 Vectored COVID-19 Vaccine

About this trial

This is an interventional prevention trial for Adenovirus Type-5 Vectored COVID-19 Vaccine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participants who has received prime vaccination of adenovirus type-5 vectored COVID-19 vaccine
Able to understand the content of informed consent and willing to sign the informed consent
Negative in HIV diagnostic test.
Axillary temperature ≤37.0°C.
General good health as established by medical history and physical examination.
Able to complete 12 months visit

Exclusion Criteria:

Family history of seizure, epilepsy, brain or mental disease
Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
Woman who is pregnant, breast-feeding on day of enrollment, or become pregnant during the next 12 months
Any acute fever disease or infections.
History of SARS
Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
Hereditary angioneurotic edema or acquired angioneurotic edema
Urticaria in last one year
No spleen or functional spleen.
Platelet disorder or other bleeding disorder may cause injection contraindication
Faint at the sight of needles.
Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months.
Prior administration of blood products in last 4 months
Prior administration of other research medicines in last 1 month
Prior administration of attenuated vaccine in last 1 month
Prior administration of inactivated vaccine in last 14 days
Current anti-tuberculosis prophylaxis or therapy
According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.

Sites / Locations

A rehabilitation centre in Wuhan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adenovirus Type-5 Vectored COVID-19 Vaccine

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of adverse reactions within 14 days after booster vaccination

Occurrence of adverse reactions within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Secondary Outcome Measures

Occurrence of adverse events within 14 days after booster vaccination

Occurrence of adverse events within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Occurrence of adverse events within 28 days after booster vaccination

Occurrence of adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Occurrence of serious adverse events within 28 days after booster vaccination

Occurrence of serious adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Occurrence of serious adverse events within 6 months after booster vaccination

Occurrence of serious adverse events within 6 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Occurrence of serious adverse events within 12 months after booster vaccination

Occurrence of serious adverse events within 12 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Changes in laboratory test indicators before and 1 day after vaccination

Changes in laboratory test indicators (including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, ALT, AST, total bilirubin, fasting blood glucose, creatinine) before and 1 day after vaccination

Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination

Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Cellular immunity at day 14 after booster vaccination

Cellular immunity at day 14 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Full Information

NCT ID

NCT04568811

First Posted

September 28, 2020

Last Updated

March 28, 2022

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04568811

Brief Title

The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine

Official Title

The Single-center, Open-label Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine in Healthy Adults Aged 18-60 Years

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

September 26, 2020 (Actual)

Primary Completion Date

October 25, 2020 (Actual)

Study Completion Date

September 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine 6 months after prime vaccination. The investigators intent to evaluate the safety and immunogenicity of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged aged 18-60 years.

Detailed Description

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This is a single-center, open-label phase I clinical trial of booster vaccination in healthy 18 to 60 years of age, inclusive, who has been prime vaccinated with adenovirus type-5 vectored COVID-19 vaccine. This clinical trial is designed to assess the safety and immunogenicity of booted vaccination of adenovirus type-5 vectored COVID-19 vaccine manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenovirus Type-5 Vectored COVID-19 Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adenovirus Type-5 Vectored COVID-19 Vaccine

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Adenovirus Type-5 Vectored COVID-19 Vaccine

Intervention Description

Low dose adenovirus type-5 vectored COVID-19 vaccine (5E10 vp)

Primary Outcome Measure Information:

Title

Occurrence of adverse reactions within 14 days after booster vaccination

Description

Occurrence of adverse reactions within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

0-14 days post-vaccination

Secondary Outcome Measure Information:

Title

Occurrence of adverse events within 14 days after booster vaccination

Description

Occurrence of adverse events within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

0-14 days post-vaccination

Title

Occurrence of adverse events within 28 days after booster vaccination

Description

Occurrence of adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

0-28 days post-vaccination

Title

Occurrence of serious adverse events within 28 days after booster vaccination

Description

Occurrence of serious adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

0-28 days post-vaccination

Title

Occurrence of serious adverse events within 6 months after booster vaccination

Description

Occurrence of serious adverse events within 6 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

6 months post-vaccination

Title

Occurrence of serious adverse events within 12 months after booster vaccination

Description

Occurrence of serious adverse events within 12 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

12 months post-vaccination

Title

Changes in laboratory test indicators before and 1 day after vaccination

Description

Time Frame

1 day post-vaccination

Title

Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination

Description

Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

14 days, 28 days, 6 months and 12 months post-vaccination

Title

Cellular immunity at day 14 after booster vaccination

Description

Cellular immunity at day 14 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

Time Frame

14 days post-vaccination

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants who has received prime vaccination of adenovirus type-5 vectored COVID-19 vaccine Able to understand the content of informed consent and willing to sign the informed consent Negative in HIV diagnostic test. Axillary temperature ≤37.0°C. General good health as established by medical history and physical examination. Able to complete 12 months visit Exclusion Criteria: Family history of seizure, epilepsy, brain or mental disease Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past. Woman who is pregnant, breast-feeding on day of enrollment, or become pregnant during the next 12 months Any acute fever disease or infections. History of SARS Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease. Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc. Hereditary angioneurotic edema or acquired angioneurotic edema Urticaria in last one year No spleen or functional spleen. Platelet disorder or other bleeding disorder may cause injection contraindication Faint at the sight of needles. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months. Prior administration of blood products in last 4 months Prior administration of other research medicines in last 1 month Prior administration of attenuated vaccine in last 1 month Prior administration of inactivated vaccine in last 14 days Current anti-tuberculosis prophylaxis or therapy According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.

Facility Information:

Facility Name

A rehabilitation centre in Wuhan

City

Wuhan

State/Province

Hubei

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine

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