A non-randomized, two-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 adolescent aged 12-18 and adults aged 18-40
The recombinant SARS-CoV-2-S protein vaccine (SpikoGen®) in adolescents aged 12 to 18 is non-inferior in immunogenicity compared to 18-40 years old adults, and it has acceptable safety
Design
A non-randomized,two-armed,non-inferiority,open label,parallel clinical trial in adolescent aged 12-18 and adults aged 18-40 with 305 volunteers in each arm
Settings and conduct
Non-randomized,two-armed,non-inferiority,open label,parallel in Orchidlife of Orchidpharmed Co.
Participants/Inclusion and exclusion criteria
Inclusion:Individuals12-40years; who are able to comply with study requirements;Healthy and stable medical conditions;Women who are not pregnant or breastfeeding;Adolescents aged 12-18, 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
1 intramuscular(IM) injection of 25 micrograms subunit vaccine with Advax-CpG adjuvant on days 0 and 21
Main outcome variables
Evaluation of non-inferiority of neutralizing antibody seroconversion in adolescents aged 12-18 compared to adults aged 18-40 years by Conventional virus neutralization test two weeks after the second dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N27
Registration date:2021-12-29, 1400/10/08
Registration timing:prospective
Last update:2021-12-29, 1400/10/08
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
2022-01-05, 1400/10/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A non-randomized, two-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 adolescent aged 12-18 and adults aged 18-40
Public title
Comparison of immunogenicity and safety of SpikoGen vaccine in adolescents aged 12 to 18 years with adults aged 18 to 40 years
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men or women 12 to 40 years
Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, and tests
Healthy adults or adults with stable medical conditions
Women eligible to participate in the study who are not pregnant or breastfeeding
In adolescents aged 12-18, 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 12 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
610
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
2021-12-22, 1400/10/01
Ethics committee reference number
IR.NREC.1400.017
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 adolescents aged 12 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 two 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 two 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
Timepoint
2 weeks after the second dose
Method of measurement
cVNT and statistical analysis
8
Description
Comparing GMFR of neutralizing antibodies in two 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 two groups
Timepoint
2 weeks after the second dose
Method of measurement
ELISA test and statistical analysis
Intervention groups
1
Description
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
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?
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