Protocol summary
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Study aim
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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
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Design
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A non-randomized,three-armed,non-inferiority,open label,parallel clinical trial with 810 volunteers in 3groups aged5-12,12-18 and 18-40
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Settings and conduct
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Non-randomized,three-armed,non-inferiority,open label,parallel in Orchidlife of Orchidpharmed Co.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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children aged5-12:1IM injection of12.5µg SpikoGen
individual aged12-40:1IM injection of25µg SpikoGen
on days0,21
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Main outcome variables
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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
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Reason for update
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Study protocol update
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Acronym
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IRCT registration information
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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
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Registration date
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2021-12-29, 1400/10/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-14, 1400/11/25
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Expected recruitment end date
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2022-03-16, 1400/12/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 5 years old to 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
810
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-02-06, 1400/11/17
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Ethics committee reference number
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IR.NREC.1400.018
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Evaluation of non-inferiority seroconversion for neutralizing antibodies
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Timepoint
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Two weeks after the second dose
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Method of measurement
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Conventional virus neutralization test(cVNT) and statistical tests
Secondary outcomes
1
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Description
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Occurrence of solicited adverse events
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Timepoint
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Up to 7 days after each dose
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Method of measurement
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Checkup, history checking and participants reports based on adverse event reporting system
2
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Description
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Occurrence of unsolicited adverse events
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Timepoint
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Up to 1 month after second dose
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Method of measurement
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Checkup, history checking and participants reports based on adverse event reporting system
3
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Description
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Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions in individuals aged 5 to 18 years
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Timepoint
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During 6 months after second dose
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Method of measurement
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Checkup, history checking and participants reports based on adverse event reporting system
4
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Description
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Comparing GMFR of antibodies against S protein in three groups
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Timepoint
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2 weeks after the second dose
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Method of measurement
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Conventional virus neutralization test(cVNT) and statistical analysis
5
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Description
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Comparing seroconversion of antibodies against S protein in three groups
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Timepoint
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2 weeks after the second dose
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Method of measurement
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ELISA test and statistical analysis
6
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Description
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Comparing GMR of antibodies against S protein
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Timepoint
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2 weeks after the second dose
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Method of measurement
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ELISA test and statistical analysis
7
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Description
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Comparing GMT of neutralizing antibodies in three groups
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Timepoint
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2 weeks after the second dose
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Method of measurement
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cVNT and statistical analysis
8
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Description
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Comparing GMFR of neutralizing antibodies in three groups
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Timepoint
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2 weeks after the second dose
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Method of measurement
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cVNT and statistical analysis
9
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Description
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Comparing GMR of neutralizing antibodies
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Timepoint
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2 weeks after the second dose
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Method of measurement
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cVNT and statistical analysis
10
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Description
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Comparing GMC of antibodies against S protein in three groups
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Timepoint
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2 weeks after the second dose
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Method of measurement
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ELISA test and statistical analysis
Intervention groups
1
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Description
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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
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Category
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Prevention
2
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Description
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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
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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CinnaGen Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Participants' data will be available for regulatory and ethics committee for decisions
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When the data will become available and for how long
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Documents including study protocol and the results will be available to the public after the study ends
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To whom data/document is available
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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
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Under which criteria data/document could be used
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With the permission of the sponsor and the approval of regulatory
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From where data/document is obtainable
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The study sponsor is responding to this request
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What processes are involved for a request to access data/document
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After contacting the principal investigator and obtaining permission from the sponsor
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Comments
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