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

• ClinicalTrials.gov Identifier: NCT04341389
• Recruitment Status: Completed
• First Posted: April 10, 2020
• Last Update Posted: May 24, 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
• Information provided by (Responsible Party): Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Tracking Information

• First Submitted Date: April 7, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: May 24, 2023
• Actual Study Start Date: April 12, 2020
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2020)

• Occurrence of adverse reactions [ Time Frame: 0-14 days post vaccination ]
• Anti SARS-CoV-2 S IgG antibody response(ELISA) [ Time Frame: 28 days post vaccination ]
• Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 28 days post vaccination ]

Original Primary Outcome Measures (submitted: April 9, 2020)

• Occurrence of adverse reactions [ Time Frame: 0-14 days post vaccination ]
• Anti SARS-CoV-2 S antibody response(ELISA) [ Time Frame: 28 days post vaccination ]
• Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 28 days post vaccination ]

Current Secondary Outcome Measures (submitted: May 14, 2020)

• Occurrence of adverse events [ Time Frame: 0-28 days post vaccination ]
• Occurrence of serious adverse reaction [ Time Frame: 0-6 months post vaccination ]
• Anti SARS-CoV-2 S IgG antibody response(ELISA) [ Time Frame: 0, 14 days and 6 months post vaccination ]
• Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 0 and 6 months post vaccination ]
• Neutralizing antibody response to Ad5-vector [ Time Frame: 0, 28 days and 6 months post vaccination ]
• IFN-γ ELISpot responses to SARS-CoV-2 spike protein [ Time Frame: 0 and 28 days post vaccination ]

Original Secondary Outcome Measures (submitted: April 9, 2020)

• Occurrence of adverse events [ Time Frame: 0-28 days post vaccination ]
• Occurrence of serious adverse reaction [ Time Frame: 0-6 months post vaccination ]
• Anti SARS-CoV-2 S antibody response(ELISA) [ Time Frame: 14 days, 6 months post vaccination ]
• Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 6 months post vaccination ]
• Neutralizing antibody response to Ad5-vector [ Time Frame: 28 days, 6 months post vaccination ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)
• 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
• 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
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
  Intramuscular injection
  Other Name: Ad5-nCoV
• Other: Placebo
  Intramuscular injection
  Other Name: Control

Study Arms

• Active Comparator: Arm 1
  1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
  Intervention: Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
• Active Comparator: Arm 2
  5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
  Intervention: Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
• Placebo Comparator: Arm 3
  Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
  Intervention: Other: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 14, 2020): 508
• Original Estimated Enrollment (submitted: April 9, 2020): 500
• Actual Study Completion Date: December 31, 2020
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04341389
• Other Study ID Numbers: JSVCT089
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
• Original Responsible Party: Same as current
• Current Study Sponsor: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Fengcai Zhu, MD; Jiangsu Province Centers of Disease Control and Prevention

• PRS Account: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
• Verification Date: May 2023