Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202110872285345 Date of Approval: 07/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Phase III Clinical Trial of Influenza Virus Vector Covid-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1)
Official scientific title A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy and Safety of Influenza Virus Vector Covid-19 Vaccine for Intranasal spray (DelNS1-2019-nCoV-RBD-OPT1) in Adults Aged 18 Years and Older.
Brief summary describing the background and objectives of the trial The novel coronavirus pneumonia (COVID-19) refers to pneumonia caused by infection with novel coronavirus (2019-nCoV or SARS-CoV-2). This infectious disease was firstly discovered by humans in December 2019 and has rapidly spread to more than 210 countries and regions around the world. In January 2020, the World Health Organization (WHO) declared the COVID-19 epidemic to be a public health emergency of international concern, and subsequently announced in March 2020 that COVID-19 has the characteristics of a pandemic. Currently, several COVID-19 vaccines have been approved for conditional marketing or emergency use and large-scale vaccination is being carried out globally. Primary objectives are: To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 for preventing virologically confirmed (RT-PCR-positive) symptomatic COVID-19 and to evaluate the safety of DelNS1-2019-nCoV-RBD-OPT1. Other Secondary Objectives includes: 1)To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against severe COVID-19; 2)To evaluate the protective efficacy ofDelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in different age groups; 3)To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically-confirmed(RT-PCR-positive)COVID-19 deaths; 4)To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in patients with chronic diseases; 5)To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically confirmed (RT-PCR positive) symptomatic COVID-19 in subjects previously administered with COVID-19 vaccine
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COVID19PRO003
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Severe Acute Respiratory Syndrome Coronavirus 2 SARS CoV 2
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 30/11/2021
Actual trial start date
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 5400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo of Influeza Virus Vector Covid19 Vaccine for Intranasal spray 0.2ml 54 Weeks Identical with the investigational vaccine in dosage form, appearance and method of vaccination, etc., other than that it does not contain the active ingredient of the vaccine. 2700 Placebo
Experimental Group Active Influenza Virus Vector COVID19 Vaccine for Intranasal Spray 0.2mls 54 weeks Active ingredients: influenza virus of receptor binding domain (RBD) gene of recombinant SARS-CoV-2 2700
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Aged ≥18 years old at the time of enrollment; 2)Be able to comply with the requirements of clinical study protocol and complete all trial procedures, and sign informed consent form; 3)Subjects who have not received any COVID-19 vaccine(marketed or investigational), those who have received at least one dose of other COVID-19 vaccines (marketed or investigational) with an interval of ≥6 months between the last dose and the date when the subjects sign the informed consent for this study; 4)Those who are negative for HIV screening (depending on the relevant policy of the country where the trial is conduct, if qualification for HIV testing is required in the country, this information will be obtained mainly by inquiry while protecting the candidate’s privacy) 5)Fertile males and females of childbearing potential who are willing to take appropriate contraceptive measures from signing ICF to 3 months after the last dose, including abstinence or effective contraceptive measures (e.g., intrauterine or implantable contraceptive devices, oral contraception, combination of contraceptive diaphragm or condom with contraceptive gel); women of childbearing potential should be negative for pregnancy test on the day of vaccination. 6)Healthy people or people with a mild underlying disease that has remained stable without exacerbation (not requiring hospitalization or without major modification of the treatment regimen) within at least 3 months prior to inclusion in the study Prior history of COVID-19;2)Positive test of total SARS-CoV-2 specific antibody using colloidal gold reagent[Only applicable to subjects without vaccination history of COVID-19 vaccine(marketedor investigational)];3)Pregnant or lactating women;4)Fever on the day of vaccination or within 3 days prior to vaccination (oral temperature ≥37.5°C/axillary temperature ≥37.3°C);5)Those who had any acute disease in the past 5 days that requires systemic antibiotic or antiviral treatment (including but not limited to the use of anti-influenza virus drugs such as Tamiflu, Relenza, Symmetrel or Flumadine);6)Those who had low immune function caused by immunodeficiency diseases, diseases of important organs,cancer, and immune diseases (e.g. Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy caused by any condition, and other immune disease that may affect immune response at the investigator’s discretion);7)Long-term use (defined as ≥14 days) of immunosuppressants or other immunomodulators (for glucocorticoids, e.g., ≥10 mg/day prednisone or equivalent dose; inhaled and topical steroids are allowed) within 6 months prior to the first vaccination;8)History of hemorrhagic diseases (e.g., factor deficiency, thrombocytopenia or other coagulation disorders), or hemorrhagic tendency, or continuous requirement of anticoagulants;9)Having received immunoglobulins and/or blood products within 3 months before receiving the investigational vaccine;10)Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination;11)Participation in a clinical trial of another product within 1 month prior to vaccination, or planning to participate in a clinical trial of another product during the study; A phase III clinical trial of influenza virus vector COVID-19 vaccine for intranasal spray (DelNS1-2019-nCoV-RBD-OPT1) Protocol No.: COVID-19-PRO-003Version No/Date: 2.0/ August 10, 2021Confidential3612)Having a history of severe allergic reactions or severe adverse reactions from previous immunizations, or allergy to any component of the investigational vaccine;13)Patients deemed by the investigator as unsuitable for using nasal spray (those with severe rhinitis or nasal deformities, etc.);14)Planning to relocate permanently from the current area prior to the completion of the study or to leave the current area for a long period (preventing compliance with the prescribed visit schedule) during the study visits;15)Other conditions that the investigators consider unsuitable for this clinical study. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 04/10/2021 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Cathedral square Castle Road Accra 190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 for preventing virologically confirmed (RT-PCR-positive) symptomatic COVID-19. To evaluate the safety of DelNS1-2019-nCoV-RBD-OPT1 As per the above section
Secondary Outcome Secondary Objectives,1. To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against severe COVID-19;2)To evaluate the protective efficacy ofDelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in different age groups;3)To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically-confirmed(RT-PCR-positive)COVID-19 deaths;4)To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in patients with chronic diseases; To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically confirmed (RT-PCR positive) symptomatic COVID-19 in subjects previously administered with COVID-19 vaccine As per the above
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kintampo Health Research Centre P.O Box 200 Kintampo 3821 Ghana
Kwame Nkrumah University of Science and Technology Kumasi Centre for Collaborative Research South-end Asuogya Road Kumasi AK000 AK9 Ghana
Navrongo Health Research Centre Upper East Region Navrongo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Beijing Wantai Biological Pharmacy Enterprise Co Ltd. No.31 Kexueyuan Road Changping district Beijing 102206 China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beijing Wantai Biological Pharmacy Enterprise Co Ltd. No.31 Kexueyuan Road, Changping district Beijing 102206 China Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seyram Kaali enquiries@kintampo-hrc.org 233208956 Bono East Region
City Postal code Country Position/Affiliation
Kitampo Ghana Coordinating PI
Role Name Email Phone Street address
Public Enquiries John Amuasi info@kccr.de 233278364389 South end Asuogya Road
City Postal code Country Position/Affiliation
Kumasi Ghana Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Hella Ghorbel hella.ghorbel@mct-cro.com 21628881436 4 Avenue de la livre Sterling Les Bergesdu Lac2
City Postal code Country Position/Affiliation
Tunis Tunisia MCT Regulatory Manager Africa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Received IPD will be de-identified before shared when requested Informed Consent Form,Statistical Analysis Plan,Study Protocol When requested NA
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information