Back to results

A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector) (CTII-nCoV)

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Placebo

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19 vaccine, Ad5-nCoV, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged between 18 and 60 years.
Able to understand the content of informed consent and willing to sign the informed consent
Able and willing to complete all the secluded study process during the whole 6 months study follow-up period.
Negative in HIV diagnostic test.
Negative in serum antibodies (IgG and IgM) screening of COVID-19.
Axillary temperature ≤37.0°C.
The BMI index is 18.5-30.0.
General good health as established by medical history and physical examination.

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 or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 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

Hubei Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Outcomes

Primary Outcome Measures

Occurrence of adverse reactions

Anti SARS-CoV-2 S IgG antibody response(ELISA)

Neutralizing antibody response to SARS-CoV-2

Secondary Outcome Measures

Occurrence of adverse events

Occurrence of serious adverse reaction

Anti SARS-CoV-2 S IgG antibody response(ELISA)

Neutralizing antibody response to SARS-CoV-2

Neutralizing antibody response to Ad5-vector

IFN-γ ELISpot responses to SARS-CoV-2 spike protein

Full Information

NCT ID

NCT04341389

First Posted

April 7, 2020

Last Updated

May 22, 2023

Sponsor

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Collaborators

CanSino Biologics Inc., Jiangsu Province Centers for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Zhongnan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04341389

Brief Title

A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)

Acronym

CTII-nCoV

Official Title

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 12, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Collaborators

CanSino Biologics Inc., Jiangsu Province Centers for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Zhongnan Hospital

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

This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.

Detailed Description

This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination

6. Conditions and Keywords

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

COVID-19

Keywords

COVID-19 vaccine, Ad5-nCoV, SARS-CoV-2

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

508 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Arm Title

Arm 3

Arm Type

Placebo Comparator

Arm Description

Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Intervention Type

Biological

Intervention Name(s)

Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Other Intervention Name(s)

Ad5-nCoV

Intervention Description

Intramuscular injection

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

Intramuscular injection

Primary Outcome Measure Information:

Title

Occurrence of adverse reactions

Time Frame

0-14 days post vaccination

Title

Anti SARS-CoV-2 S IgG antibody response(ELISA)

Time Frame

28 days post vaccination

Title

Neutralizing antibody response to SARS-CoV-2

Time Frame

28 days post vaccination

Secondary Outcome Measure Information:

Title

Occurrence of adverse events

Time Frame

0-28 days post vaccination

Title

Occurrence of serious adverse reaction

Time Frame

0-6 months post vaccination

Title

Anti SARS-CoV-2 S IgG antibody response(ELISA)

Time Frame

0, 14 days and 6 months post vaccination

Title

Neutralizing antibody response to SARS-CoV-2

Time Frame

0 and 6 months post vaccination

Title

Neutralizing antibody response to Ad5-vector

Time Frame

0, 28 days and 6 months post vaccination

Title

IFN-γ ELISpot responses to SARS-CoV-2 spike protein

Time Frame

0 and 28 days post vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged between 18 and 60 years. Able to understand the content of informed consent and willing to sign the informed consent Able and willing to complete all the secluded study process during the whole 6 months study follow-up period. Negative in HIV diagnostic test. Negative in serum antibodies (IgG and IgM) screening of COVID-19. Axillary temperature ≤37.0°C. The BMI index is 18.5-30.0. General good health as established by medical history and physical examination. 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 or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fengcai Zhu, MD

Organizational Affiliation

Jiangsu Province Centers of Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hubei Provincial Center for Disease Control and Prevention

City

Wuhan

State/Province

Hubei

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32702299

Citation

Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.

Results Reference

derived

Learn more about this trial

A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)

We'll reach out to this number within 24 hrs