Protocol summary

Study aim
Evaluation of safety and immunogenicity of recombinant protein sub-unit COVID-19 vaccine (Razi Cov Pars) in healthy adolescents aged 12-17
Design
Single group, open label study will be conducted on 210 volunteers
Settings and conduct
Recruitment centers:1. Razi Vaccine and Serum Research Institute, Hesarak, Karaj 2.Rasoul Akram Hospital, Shahrara,Tehran
Participants/Inclusion and exclusion criteria
Important inclusion criteria: Volunteer's legal guardian should be able to read and write; Age between 12-17 years; Negative N antibody titer against COVID-19; Negative RT-PCR tests for COVID-19; Signed informed consent; Non pregnant or lactating (women); Important exclusion criteria: Any ongoing, symptomatic, uncontrolled, acute or chronic illness requiring medication or surgery (including respiratory/cardiac diseases, uncontrolled hypertension, uncontrolled diabetes, neurological diseases, serious psychiatric disorder & blood disorders); History of allergic diseases or reactions to any drug/vaccine.
Intervention groups
One vaccine group receiving 10μg/200μl. They will receive two injections on day 0 and 21 followed by an intranasal dose on day 51.
Main outcome variables
Primary outcomes: Immediate abnormal vital signs & anaphylactic reactions after vaccination: Local & Systemic adverse events within the first week post vaccination; abnormal lab findings within one week of vaccination; Neutralizing antibody activity VNT on days 0, 35, 90, and 180. Secondary outcomes: SAEs, SUSARs, MAAEs, up to 6 months after the second vaccine dose; Serum ELISA IgG level for SARS CoV- 2 antigens S1, RBD and cell-mediated immunity on days 0, 35, 90, and 180.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201214049709N5
Registration date: 2022-02-09, 1400/11/20
Registration timing: prospective

Last update: 2022-02-09, 1400/11/20
Update count: 0
Registration date
2022-02-09, 1400/11/20
Registrant information
Name
Ali Eshaghi
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0038
Email address
a.eshaghi@rvsri.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy adolescents aged 12-17 years; single group, open label study
Public title
Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy adolescents aged 12-17 years
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteer's legal guardian should be able to read and write Age between 12-17 years Having good health based on clinical and laboratory criteria Negative IgG and IgM antibody titers for COVID-19 N antigen Negative RT-PCR test for COVID-19 Signed the informed consent form Not being pregnant based on the first day of the last menstrual period Negative pregnancy test based on bHCG on the day of screening and the day of vaccination Use of at least one effective method of contraception (condoms, oral contraceptive pills, intrauterine device, Norplant capsule) and willing to continue using it in female couples
Exclusion criteria:
Any ongoing, symptomatic acute or chronic illness requiring continuous medical or surgical care on the day of vaccination Breastfeeding Received any Covid Vaccine Received any vaccine during the 14-days period prior to the screening day Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day History of long-term use of immunosuppressive medication (defined as more than 14 continuous days) in the last 6 months leading up to screening day Long-term use (defined as more than 14 continuous days) of systemic corticosteroids within the past 6 months History of severe allergic diseases (such as Dyspnea, angioedema or anaphylactic reactions) History of any allergy to the drug or vaccine (defined as any clinical signs or symptom of itching at the injection site, urticaria in the body after injection, excessive redness at the injection site) History of immunological disorder (congenital or acquired) History of chemotherapy in the last 5 years History of cancer in the last 5 years History of acute and serious psychiatric illnesses History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, deficiency of blood factors) Severe acute or chronic renal and hepatic failure based on laboratory parameters Suffering from chronic obstructive pulmonary disease such as asthma, or severe renal/hepatic diseases requiring continuous treatment by a specialist Uncontrolled hypertension (systolic blood pressure > 140 and diastolic blood pressure > 90) Uncontrolled Diabetes History of chronic neurological diseases (including seizures and epilepsy) Any history of substance or alcohol abuse Grade 1 or higher abnormal laboratory (hematology or biochemistry) tests based on FDA toxicity score on the screening day History of confirmed COVID-19 diseases during the 6-months period before the screening day (PCR Test or clinical diagnosis) Acute febrile illness at the time of vaccination History of allergy to acetaminophen Acute or chronic hepatitis B and C Receiving prophylactic drug against tuberculosis History of faint when see blood Splenectomy for any reason Any close contact with a confirmed COVID-19 case within two weeks before the first dose of vaccine History of congenital disorders, developmental disorders, severe malnutrition or genetic diseases Participating in any clinical trials (research) other than this study
Age
From 12 years old to 17 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 210
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Research Ethics Committee
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۸۱۴۵۵۶۱۸
Approval date
2022-02-06, 1400/11/17
Ethics committee reference number
IR.NREC.1400.019

Health conditions studied

1

Description of health condition studied
SARS-CoV-2
ICD-10 code
U07.1
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Abnormal vital signs and anaphylactic reactions immediately after vaccination: Number and percentages of participants who develop abnormal vital signs within half-hours of receiving the vaccine at each doses. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and after vaccination will be recorded. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked after each vaccination.
Timepoint
Before vaccination and 30 minutes after vaccination at each dose
Method of measurement
Temperature is measured using a digital thermometer. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured by a digital sphygmomanometer

2

Description
Local adverse reactions: The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching)
Timepoint
The first seven days after 1st and 2nd vaccine dose (Days 0-7 and 21-28)
Method of measurement
The required information will be collected using the application installed on the mobile phones of the volunteer or their legal guardian. Volunteer will be contacted if they do not complete information on their application.

3

Description
Systemic adverse event: The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain)
Timepoint
The first seven days after each vaccine dose (Days 0-7, 21-28, 51-58)
Method of measurement
The required information will be collected using the application installed on the mobile phones of the volunteer or their legal guardian. Volunteer will be contacted if they do not complete information on their application.

4

Description
ََAbnormal laboratory findings: The number and percentage of people who shows abnormal laboratory findings one week after vaccination (Based on FDA toxicity score), including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes, Neutrophils, Eosinophils, Platelets ESR, CRP, Sodium, Potassium, BUN, Creatinine, Alkaline phosphatase, ALT, AST, and U/A, Urine protein, Urine glucose, Urine RBC
Timepoint
Seven days after each vaccine dose (Days 7, 28, 58)
Method of measurement
Each test will be performed using the appropriate kit.

5

Description
Measurement of neutralizing antibody titers to assess humoral immunity
Timepoint
Neutralizing antibody titers will be assessed on days 0, 35, 90 and 180 and comparison will be made between day 0 and other time points.
Method of measurement
Virus Neutralization Test (VNT)

Secondary outcomes

1

Description
Severe Adverse event (SAEs), Suspected Unexpected Serious Adverse Reaction (SUSAR ) and Medically Attended Adverse Events (MAAEs)
Timepoint
Weekly until sixth month after second vaccine dose
Method of measurement
The required information will be collected using the weekly questions form through the installed application on the volunteer mobile phone or their legal guardian. Volunteer will be contacted if they do not complete information on their application.

2

Description
Measurement of serum levels of specific IgG antibodies against S1 and RBD components of SARS-CoV-2 spike protein antigen (s)
Timepoint
Measurement will be done on days zero, 35, 90 and 180 and comparison will be made between day 0 and other time points.
Method of measurement
Will be measured using ELISA method

3

Description
Evaluation of cell-mediated immunity by counting CD3, CD4 and CD8 cells number, joint calculation of CD3, CD4 and CD3,CD8. IFN-γ, TNF-α, and interleukin 2, 4, 6, and 17 will also be measured.
Timepoint
Cell mediated immunity will be assessed on days 0, 35, 90 and 180 and comparison will be made between day 0 and other time points.
Method of measurement
Immunologic lab tests

Intervention groups

1

Description
Intervention group: Participants in this group will receive two doses (IM) of RAZI recombinant spike protein vaccine 21 days apart followed by a nasal spray 51 days after the first dose (day 0).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Vaccine and Serum Research Institute
Full name of responsible person
Dr Mojtaba Noofeli
Street address
Hesarak, Beheshti Ave
City
Tehran
Province
Alborz
Postal code
3197619751
Phone
+98 26 3457 0038
Email
noofeli1234@yahoo.com

2

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Ladan Mokhberosafa
Street address
Niayaesh Avenue
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1000
Email
lady.Katbi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Ali Eshaghi
Street address
Beheshti Ave, Hesarak, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
+98 26 3457 0038
Email
a.Eshahghi@rvsri.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Vaccine and Serum Research Institute
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Mohammad Hossein Fallah Mehrabadi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Hesarak - Shahid Beheshti street- Karaj
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
+98 26 3457 0038
Fax
Email
mhf2480@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeid Kalantari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Corner of Mansouri, Niayesh, Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1000
Email
kalantari.s@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Ladan Mokhberossaf
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Beheshti Ave, Hesarak, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
00982634570038-46
Email
lady.Katbi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
De-identified IPD related to outcome will be shared.
When the data will become available and for how long
The access period will begin once the study is complete and the main results have been published in peer reviewed journals.
To whom data/document is available
The data that have been published in peer reviewed journals, will be available just for academic researchers.
Under which criteria data/document could be used
The proposed study protocol should be submitted to RAZI vaccine and serum research institute and approved by its scientific and technical committee
From where data/document is obtainable
After publishing the article, researchers can submit their request to Dr. Mohammad Hossein Fallah at the following email address (mhf2480@yahoo.com )
What processes are involved for a request to access data/document
Data will be made available after consideration and approval by the relevant authorities from Razi Vaccine and Serum Research Institute.
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