An interventional study of SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in COVID-19, sponsored by Cinnagen. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Cinnagen · Not applicable, Interventional, and Prevention
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Among 43 studies in COVID-19 with a site in Iran, Islamic Republic of — none open to participants now, none under way, none of them phase 3. COVID-19 · Iran, Islamic Republic of.
Among the 43 studies in COVID-19 with a site in Iran, Islamic Republic of, this one is the 19th largest by enrollment of the 33 interventional ones that give a count, is one of 2 that started in 2022, is one of 11 with no phase, and was the 40th registered.
7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →None of the 43 studies in COVID-19 with a site in Iran, Islamic Republic of is open now. The open studies under COVID-19, anywhere →
Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 11 · Phase 3 8 · Phase 4 4
First in 2020; this study’s year is marked. 2 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 43 is below the median of 102 across 4,365 interventional studies indexed under COVID-19.
Median enrollment 50 across the 33 interventional studies, 240 across the 10 observational. Of the 25 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 43 have an industry lead sponsor. The 10 most frequent:
Cinnagen is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Cinnagen has 5 studies filed under COVID-19 — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 43 studies in COVID-19 with a site in Iran, Islamic Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. in kidney transplant recipients after two doses of Sinopharm's inactivated virus vaccine. A total of 100 adult individuals receive a single dose of the SpikoGen COVID-19 vaccine at 1 to 3 months after the second dose of the Sinopharm COVID-19 vaccine. The injection is given in the deltoid muscle of the non-dominant arm. For immunogenicity assessments, blood samples will be collected one month after the booster injection. For safety assessments, all participants will be followed up for one month.
Study hypotheses include:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Drug page: SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine
SARS-CoV-2 recombinant spike protein (25 μg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm
Also known as: SpikoGen, COVAX-19
Percentage of participants with seroconversion for S1 binding IgG antibodies
As measured by ELISA
Time frame: One month after the booster dose
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
As measured by ELISA
Time frame: One month after the booster dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
As measured by ELISA
Time frame: One month after the booster dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Time frame: One month after the booster dose
Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Time frame: One month after the booster dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
As measured by ELISA
Time frame: One month after the booster dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Time frame: One month after the booster dose
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Time frame: One month after the booster dose
Change in T-cell IFN-γ secretion from baseline to one month after the booster dose
As measured by IGRA
Time frame: Baseline and one month after the booster dose
Incidence of solicited adverse events
Injection site pain, erythema, swelling, and induration, axillary swelling or tenderness ipsilateral to the side of injection, fever (oral temperature), headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills, as reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: For 7 days after the booster dose
Incidence of unsolicited adverse events
As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: For one month after the booster dose
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Mar 2022, 1 month.
Of 138 industry-sponsored interventional studies with no phase under COVID-19, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 1 month is below that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine
Cinnagen