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Protocol summary

Study aim
The recombinant SARS-CoV-2-S protein vaccine (SpikoGen®) in individuals aged 5-18 and adults aged 18-40 is non-inferior in immunogenicity and it has acceptable safety
Design
A non-randomized,three-armed,non-inferiority,open label,parallel clinical trial with 810 volunteers in 3groups aged5-12,12-18 and 18-40
Settings and conduct
Non-randomized,three-armed,non-inferiority,open label,parallel in Orchidlife of Orchidpharmed Co.
Participants/Inclusion and exclusion criteria
Inclusion:Individuals5-40years; who are able to comply with study requirements;Healthy and stable medical conditions;Women who are not pregnant or breastfeeding;Individuals aged 5-18, body mass index should be equal percentile or higher, according to WHO standards.Exclusion:Subjects with active infection with signs of SARS-COV-2;People with epilepsy or a history of febrile seizure;Receive immunosuppressive medications;People with history of severe adverse reactions to the vaccine;Who participated or intend to participate in clinical trials within 30 days before screening until end of the study.Who have previously vaccinated against SARS-CoV-2;Who received other authorized vaccines within 28 days prior to the screening/intend to receive vaccine up to 14 days after second dose;People with known bleeding disorder;People with special circumstances who,in the researcher's view,may increase the risk of participating in the study;Who received/intend to receive any blood/blood products 90 days or donated ≥450ml 28 days prior to screening.
Intervention groups
children aged5-12:1IM injection of12.5µg SpikoGen individual aged12-40:1IM injection of25µg SpikoGen on days0,21
Main outcome variables
Evaluation of non-inferiority of neutralizing antibodies seroconversion in children aged 5-12,adolescents aged 12-18 and adults aged 18-40 by Conventional virus neutralization test(cVNT) two weeks after the second dose

General information

Reason for update
Study protocol update
Acronym
IRCT registration information
IRCT registration number: IRCT20150303021315N27
Registration date: 2021-12-29, 1400/10/08
Registration timing: prospective

Last update: 2022-02-13, 1400/11/24
Update count: 1
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-14, 1400/11/25
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A non-randomized, three-armed, non-inferiority, open label, parallel clinical trial to compare the immunogenicity and safety of SpikoGen® vaccine (an adjuvanted recombinant spike (S) protein produced by CinnaGen Co.) in children aged 5-12, adolescents aged 12-18 and adults aged 18-40
Public title
Comparison of immunogenicity and safety of SpikoGen vaccine in children aged 5 to 12 years, adolescents aged 12 to 18 years and adults aged 18 to 40 years
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Chidren, men or women 5 to 40 years Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, and tests Healthy individuals or individuals with stable medical conditions Women eligible to participate in the study who are not pregnant or breastfeeding In children and adolescents aged 5-18, body mass index should be equal percentile or higher, according to WHO child development standards
Exclusion criteria:
Subjects with active infection with SARS-COV-2 signs at the screening visit. If subject has history of infection as passed it, involving has no problem People with epilepsy or a history of febrile seizures People who are being treated with immunosuppressive drugs. Among the cytotoxic agents or systemic corticosteroids, for example, for cancer, autoimmune disease or organ transplants or require a specific medical prescription during the study period. Receiving cytotoxic and chemotherapy drugs at any dose will prevent people from entering the study People who have a history of severe allergic reactions (e.g. anaphylaxis) to any components of the vaccine being studied or other drugs Individuals who have received any other research product within 30 days prior to screening visit or intend to participate in another clinical study at the time of this study People who have previously been vaccinated with any type of vaccine against the SARS-CoV-2 virus Individuals who received other authorized vaccines (such as Influenza vaccine or Gardasil) within 28 days prior to the screening visit in this study or intend to receive each vaccine up to 14 days after the second vaccination People who have a known bleeding disorder and who, according to the researcher, may have problems with the intramuscular injection People who have received or intend to receive any blood/plasma or immunoglobulin products during the 90 days prior to the screening visit People with special circumstances who, in the researcher's view, may increase the risk of participating in the study or interfering with the evaluation of the initial objectives of the study People who have donated more than or equal to 450 ml of blood or blood products in the 28 days before the screening visit
Age
From 5 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 810
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
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
1467664961
Approval date
2022-02-06, 1400/11/17
Ethics committee reference number
IR.NREC.1400.018

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Evaluation of non-inferiority seroconversion for neutralizing antibodies
Timepoint
Two weeks after the second dose
Method of measurement
Conventional virus neutralization test(cVNT) and statistical tests

Secondary outcomes

1

Description
Occurrence of solicited adverse events
Timepoint
Up to 7 days after each dose
Method of measurement
Checkup, history checking and participants reports based on adverse event reporting system

2

Description
Occurrence of unsolicited adverse events
Timepoint
Up to 1 month after second dose
Method of measurement
Checkup, history checking and participants reports based on adverse event reporting system

3

Description
Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions in individuals aged 5 to 18 years
Timepoint
During 6 months after second dose
Method of measurement
Checkup, history checking and participants reports based on adverse event reporting system

4

Description
Comparing GMFR of antibodies against S protein in three groups
Timepoint
2 weeks after the second dose
Method of measurement
Conventional virus neutralization test(cVNT) and statistical analysis

5

Description
Comparing seroconversion of antibodies against S protein in three groups
Timepoint
2 weeks after the second dose
Method of measurement
ELISA test and statistical analysis

6

Description
Comparing GMR of antibodies against S protein
Timepoint
2 weeks after the second dose
Method of measurement
ELISA test and statistical analysis

7

Description
Comparing GMT of neutralizing antibodies in three groups
Timepoint
2 weeks after the second dose
Method of measurement
cVNT and statistical analysis

8

Description
Comparing GMFR of neutralizing antibodies in three groups
Timepoint
2 weeks after the second dose
Method of measurement
cVNT and statistical analysis

9

Description
Comparing GMR of neutralizing antibodies
Timepoint
2 weeks after the second dose
Method of measurement
cVNT and statistical analysis

10

Description
Comparing GMC of antibodies against S protein in three groups
Timepoint
2 weeks after the second dose
Method of measurement
ELISA test and statistical analysis

Intervention groups

1

Description
First intervention group: Injecting one dose of 1 ml solution of SpikoGen® vaccine containing recombinant SARS-CoV-2-S protein and Advax™ and CpG adjuvants in the non-dominant arm on days 0 and 21 in individuals aged 12-40
Category
Prevention

2

Description
Second intervention group: Injecting one dose of 0.5 ml solution of SpikoGen® vaccine containing recombinant SARS-CoV-2-S protein and Advax™ and CpG adjuvants in the non-dominant arm on days 0 and 21 in individuals aged 5-12
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Orchidlife department in Orchidpharmed Co.
Full name of responsible person
Payam Tabarsi
Street address
No. 42, Attar Ave., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
ask@orchidpharmed.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
CinnaGen Company
Full name of responsible person
Dr. Haleh Hamedifar
Street address
No.72, CinnaGen research and production Company. Simin Dasht Industrial Park, Karaj, Alborz, Iran
City
Karaj
Province
Alborz
Postal code
3165933155
Phone
+98 26 3667 0980
Email
cinnagen@cinnagen.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CinnaGen Company
Proportion provided by this source
100
Public or private sector
Private
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
Orchidpharmed
Full name of responsible person
Nassim Anjidani
Position
Medical Department Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 42. Attar sq, Attar st, Valiasr st, Vanak sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
anjidani.n@orchidpharmed.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Payam Tabarsi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
tabarsi@nritld.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Orchid Pharmed
Full name of responsible person
Nassim Anjidani
Position
Medical Department Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 42. Attar sq, attar st, valiasr st, vanak sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
Anjidani.n@orchidpharmed.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participants' data will be available for regulatory and ethics committee for decisions
When the data will become available and for how long
Documents including study protocol and the results will be available to the public after the study ends
To whom data/document is available
The regulatory body and the ethics committee will have access to the study data. The monitoring team will have access to the study data during the conduct. DSMB will have access to the study data and results in predefined timelines and decides about the continuation of the study
Under which criteria data/document could be used
With the permission of the sponsor and the approval of regulatory
From where data/document is obtainable
The study sponsor is responding to this request
What processes are involved for a request to access data/document
After contacting the principal investigator and obtaining permission from the sponsor
Comments
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