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

NCT04341389 | Completed Phase 2 DMC

• 1 other identifier: JSVCT089
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Occurrence of adverse reactions

  0-14 days post vaccination

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

  28 days post vaccination

• Neutralizing antibody response to SARS-CoV-2

  28 days post vaccination

Secondary Outcomes (6)

• Occurrence of adverse events

  0-28 days post vaccination

• Occurrence of serious adverse reaction

  0-6 months post vaccination

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

  0, 14 days and 6 months post vaccination

• Neutralizing antibody response to SARS-CoV-2

  0 and 6 months post vaccination

• Neutralizing antibody response to Ad5-vector

  0, 28 days and 6 months post vaccination

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

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

Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Arm 2

ACTIVE COMPARATOR

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

Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Arm 3

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) BIOLOGICAL

Intramuscular injection

Also known as: Ad5-nCoV

Arm 1; Arm 2

Placebo OTHER

Intramuscular injection

Also known as: Control

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China: lead
• CanSino Biologics Inc.: collaborator
• Jiangsu Province Centers for Disease Control and Prevention: collaborator
• Hubei Provincial Center for Disease Control and Prevention: collaborator
• Zhongnan Hospital: collaborator

Study Sites (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

Related Publications (2)

• Feng JL, Wang WJ, Jin PF, Zheng H, Jin LR, Xia X, Zhang XY, Li ZP, Li JX, Zhu FC. Comparison of antibody persistency through one year between one-dose and two-dose regimens of Ad5-nCoV vaccine for COVID-19. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230760. doi: 10.1080/21645515.2023.2230760.

  PMID: 37428653 DERIVED

• 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.

  PMID: 32702299 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ad5-nCoV vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fengcai Zhu, MD

  Jiangsu Province Centers of Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 12, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)