A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV

This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

Detailed Description

This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above.

The study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine .

The immunization schedule is two doses intramuscular injections (deltoid).

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Taizhou, Jiangsu, China, 210000
      • Taixing City center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18 to 55 years old in MID group; aged 6-17 years old in MIN group; aged 56 years and above in OLD group; aged in EBO group is not limited.
• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MID A; 20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Intramuscular other name:Ad5-nCoV
Placebo Comparator: MID B; 10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo; Intramuscular other name:Ad5-nCoV
Experimental: MIN A; 100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Intramuscular other name:Ad5-nCoV
Placebo Comparator: MIN B; 50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo; Intramuscular other name:Ad5-nCoV
Experimental: OLD A; 100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Intramuscular other name:Ad5-nCoV
Experimental: OLD B; 100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Intramuscular other name:Ad5-nCoV
Placebo Comparator: OLD C; 50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo; Intramuscular other name:Ad5-nCoV
Experimental: EBOV A; 34 participants, Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Intramuscular other name:Ad5-nCoV
Placebo Comparator: EBOV B; 17 participants, Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo; Intramuscular other name:Ad5-nCoV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety indexes of adverse reactions	Occurrence of adverse reactions post vaccination	within 14 days post each vaccination
Immunogencity indexes of GMT	Evaluate the Geometric mean titer (GMT) of IgG antibody	Day 28 post the second vaccination
Immunogencity indexes of neutralizing antibody	Evaluate the Geometric mean titer (GMT) of neutralizing antibody	Day 28 post the second vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety indexes of adverse events	Occurrence of adverse reactions post-vaccination	Day 0-7,0-14,0-28 post each vaccination
Safety indexes of Hematological examination measures（Hemoglobin, WBC）	Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)	pre-vaccination, day 4 post each vaccination
Safety indexes of Blood routine measures(ALT, AST)	Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)	pre-vaccination, day 4 post each vaccination
Safety indexes of SAE	Occurrence of serious adverse events post-vaccination	Within 6 months post the second vaccination
Immunogencity indexes of GMT	Evaluate the Geometric mean titer of IgG antibody	Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Immunogencity indexes of neutralizing antibody	Evaluate the Geometric mean titer (GMT) of neutralizing antibody	Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Immunogencity indexes of cellular immune	Number of cell-mediated immune response against SARS-CoV-2（IL-2）	Day 28 post the first vaccination, pre and day 28 post the second vaccination

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Collaborators: Jiangsu Province Centers for Disease Control and Prevention; Beijing Institute of Biotechnology

Publications and helpful links

General Publications

• Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H, Hou L, Li J, Wang X, Wu S, Wang Y, Gou J, Huang H, Wu H, Wang X, Chen W. Safety and Immunogenicity of a Recombinant Adenovirus Type-5-Vectored Coronavirus Disease 2019 (COVID-19) Vaccine With a Homologous Prime-Boost Regimen in Healthy Participants Aged >/=6 Years: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Trial. Clin Infect Dis. 2022 Aug 24;75(1):e783-e791. doi: 10.1093/cid/ciab845.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): September 21, 2021
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Safety; Vaccine; COVID-19; Ad5; Adenovirus Vector; Immunogencity
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: JSVCT093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No