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Comparison of immunogenicity and safety of Razi Cov Pars and Sinopharm booster doses in adults 18 years of age and older who have primarily vaccinated with Sinopharm: a ‎parallel ‎‏2‏‎ arms, ‎randomised, double blind clinical trial ‎

Protocol summary

Study aim
Comparison of immunogenicity and safety of Razi Cov Pars and ‎Sinopharm booster doses in adults 18 years of age and older who have primarily vaccinated with Sinopharm: a ‎parallel ‎‏2‏‎ arms, ‎randomised, double blind clinical trial ‎
Design
A randomized, double blind, parallel groups, controlled trial on 500 participants.
Settings and conduct
Study setting: 1. Razi Vaccine and Serum Research Institute, Karaj 2. Rasoul hospital, Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: having Iranian citizenship or in the case of foreign nationals with a legal residence permit, age 18 years and older, history of complete vaccination with Sinopharm vaccine at least 90 days and at most 195 days from the last vaccination. Main exclusion criteria: History of allergic diseases such as angioedema or anaphylactic reactions after receiving previous COVID vaccines (including urticaria and fever); Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care; Pregnancy and lactation; Immunodeficiency diseases (Suspected and Definitive); History of uncontrolled serious psychiatric illnesses; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors); History of chronic neurological diseases (including seizures and epilepsy); Acute febrile illness at the time of booster vaccine injection.
Intervention groups
One group will receive Razi Cov Pars, and the other Sinopharm vaccine (a single dose).
Main outcome variables
Neutralizing antibody activity 2wks, 3 and 6 month after injection; Abnormal vital signs and anaphylactic reactions; Local and systemic reactions within the first week after booster dose; SAEs, SUSARs, MAAEs; IgG level for SARS-CoV-2, S1, RBD antigens; Cell-mediated immune response (lymphoproliferation, INFy, TNFa, CD3/CD8 ratio) following stimulation by S antigen.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201214049709N4
Registration date: 2021-11-29, 1400/09/08
Registration timing: prospective

Last update: 2021-11-29, 1400/09/08
Update count: 0
Registration date
2021-11-29, 1400/09/08
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
Recruitment complete
Funding source
Expected recruitment start date
2021-11-30, 1400/09/09
Expected recruitment end date
2022-02-28, 1400/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of immunogenicity and safety of Razi Cov Pars and Sinopharm booster doses in adults 18 years of age and older who have primarily vaccinated with Sinopharm: a ‎parallel ‎‏2‏‎ arms, ‎randomised, double blind clinical trial ‎
Public title
Comparison of immunogenicity and safety of Razi Cov Pars and ‎Sinopharm booster doses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian citizenship; Age 18 years and older; Having history of full vaccination with Sinopharm vaccine (two doses) 75 to 195 days from the last vaccination; Signing an informed consent form; For females of childbearing age 18 to 49 years: use of at least one effective method of contraception (condom, oral contraceptive pills, intrauterine device, norplant capsule) and willing to continue up to two month after the booster dose.
Exclusion criteria:
History of allergy to drugs or vaccines (e.g urticaria and fever); Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care; Severe cardiovascular disease; Breastfeeding; History of receiving any vaccine within 14 days before receiving the booster dose; History of diseases resulting in immunosuppression (suspected and definite); History of long-term use of immunosuppressive drugs, including history of long-term use of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) with the exception of topical steroids (more than 14 consecutive days) within the past 4 months; History of uncontrolled serious psychiatric illnesses; History of chronic neurological diseases (including seizures and epilepsy)؛ Acute febrile illness at the time of booster vaccine injection; Splenectomy for any reason; Close contact with a confirmed COVID-19 case within two weeks before the booster dose; Continued use of anticoagulants such as coumarin and related anticoagulants (such as warfarin) or new oral anticoagulants / antiplatelet agents. Note: Less than 325 mg of aspirin per day is allowed as prophylaxis; Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer; Received blood and/or any blood products and/or immunoglobulins within three months preceding the booster dose; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors); Current substance or alcohol abuse; Pregnancy based on the participant's statement and the time of the first day of the last menstrual period and negative pregnancy test (baby check) on the day of vaccination; History of COVID -19 based on laboratory or clinical evidence after primary vaccination; Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 500
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, stratified block randomization method with block size of 4 was used to assign each participant to the intervention groups. The rand() function of Excel software were used to generate random sequence within each block. After determining the allocated intervention, a non-repetitive five-digit random code was assigned to each participant.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the control group will receive the Sinopharm vaccine, which has different packaging and shape compared to Razi Cov Pars. Therefore, implementation of blinding will be done by a person who will be responsible for this. This is the only person who will not be blind to the intervention given. Once the participant becomes eligible to receive the vaccine, a concealment/randomization code will be assigned to the volunteer and the vaccine type will be displayed on the screen of the vaccinator until the inoculation is confirmed.
Placebo
Not used
Assignment
Parallel
Other design features
Alongside the main study, four additional groups of participants, 25 each, who have been primarily vaccinated by either of Astrazeneca, Sputnik V, Razi CoV Pars, and Pastocovac vaccines within the last 4 to 6 month, will receive one dose of Razi CoV Pars.

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
7334144696
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.NREC.1400.013

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
Neutralizing antibody activity
Timepoint
On day zero, two weeks, 3 and 6 months after the booster dose injection
Method of measurement
SARS-CoV-2 virus neutralizing antibody titter measured in bio-safety level III lab using conventional method

Secondary outcomes

1

Description
Serum levels of specific IgG antibodies against S1, RBD antigens
Timepoint
On day zero, two weeks, 3 and 6 months after the booster dose vaccine
Method of measurement
ELISA method

2

Description
The cell-mediated immunity will be evaluated by counting the number of CD3, CD4 and CD8 cells and joint calculation of CD3 and CD4 and CD3 and CD8 . IFN-γ, TNF-α, and interleukins 2, 4, 6, and 17 will also be measured. It will be will be assessed in 20 members of the selected group. Summary of the measures performed in this section are as follows: 1- Assessment of CD4 to CD8 cell proportions after stimulation of PBMC (Peripheral Blood Mononuclear Cells) by inactivated virus and recombinant spike protein using flow cytometry 2- Assessment of specific proliferation of PBMC cells stimulated by inactivated virus and recombinant spike protein using flow cytometry 3 - Assessment of TH1 and TH2 specific cellular immunity after PBMC stimulation in vaccinated individuals with recombinant spike protein to determine the levels of interferon-gamma, interleukin-4, tumor necrosis factor-alpha and interleukin 6 using ELISpot and ELISA kit.
Timepoint
On day zero, two weeks, 3 and 6 months after the booster dose vaccine
Method of measurement
Immunologic lab tests

3

Description
Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. 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 up to half an hour after vaccine booster dose.
Timepoint
Before vaccination and half an hour after vaccination
Method of measurement
Clinical examination

4

Description
The number and percentage of local adverse reaction within the first week post-vaccination (including pain, tenderness, erythema / redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity.
Timepoint
Daily, within the first week after booster dose
Method of measurement
Via mobile application, study staff will contact participants who fail to fill their application and complete a local adverse reaction form on their behalf.

5

Description
The number and percentage of systemic adverse reaction within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) that will be assessed based on the severity score, duration and peak intensity.
Timepoint
Seven days after booster dose (Days 0-7) daily assessment.
Method of measurement
Via mobile application, study staff will contact participants who fail to fill their application and complete a systemic adverse reaction form on their behalf.

6

Description
Number and percentage of Severe Adverse event (SAEs), Suspected Unexpected Serious Adverse Reaction (SUSAR ) and Medically Attended Adverse Events (MAAEs) Up to one month after receiving the booster dose.
Timepoint
Up to one month after the booster dose
Method of measurement
Via mobile application. There will be a 24-7 follow up center with physicians available all the time.

Intervention groups

1

Description
Intervention group 1: Participants in this group will receive one doses (IM) of RAZI recombinant spike protein vaccine (day 0)
Category
Prevention

2

Description
Intervention group 2: Participants in this group will receive one doses (IM) of Sinopharm vaccine (day 0).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Ladan Mokhberossafa
Street address
Corner of Mansouri, Niayesh, Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1000
Email
lady.Katbi@yahoo.com

2

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

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
Academic

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
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
Deidentified 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 availabe after consideration and approval by the relevant authorities from Razi Vaccine and Serum Research Institute.
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