ClinicalTrials.gov
Trial records, trial locations and study sponsors
ClinicalTrials.gov helps users find studies and view public trial records, including sponsor-run or funded studies; site distances are approximate, and contacts, eligibility, or exact dates may be missing.
Your information
The trial title or NCT trial number, for example NCT04368728.
Example results
- Phase
- Phase 3
- Title
- Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine
- Status
- Completed
- Sponsor
- Cinnagen
- Age Range
- 18 Years and older
- Start Date
- 2021-12-15
- Trial Link
- clinicaltrials.gov
- Trial Number
- NCT05175625
- Official Title
- A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen)
- Results Posted
- No
- Completion Date
- 2022-06-20
- Purpose Summary
- This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. A total of 300 adult individuals received a single dose of either the SpikoGen vaccine or the saline placebo in a 5:1 ratio at 4 to 9 months after the second dose of a COVID-19 vaccine of any type. The injection was given in the deltoid muscle of the non-dominant arm. On day 14, the trial was unblinded, and the participants in the placebo group received a booster dose of the SpikoGen vaccine. For immunogenicity assessments, blood samples were collected on days 0 and 14 from all participants and on days 90 and 180 from those in the vaccine group only. For safety assessments, all participants were followed up for six months. Study hypotheses included: 1. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult subjects. 2. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult subjects.
- Eligibility Criteria
- Inclusion Criteria: * Male or female ≥18 years * Willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests * Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit * Subjects who have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit Exclusion Criteria: * Subjects with signs of active SARS-CoV-2 infection at the screening visit or within 72 hours prior to the screening visit * Subjects who have been diagnosed with a breakthrough infection after receiving two doses of a COVID-19 vaccine * Subjects with epilepsy or a history of febrile seizures * Subjects who receive immunosuppressive or cytotoxic medications. * Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products. * Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study. * Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study. * Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection. * Female Subjects who are pregnant or breastfeeding or have planned to become pregnant within one month after the study injection. * Subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period. * Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion. * Subjects who have donated ≥450 mL of blood or blood products within 28 days prior to the screening visit.
- Number of Participants
- 300
- Arms
Arms Name Type Treatments Description SpikoGen COVID-19 VaccineExperimentalBiological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant—Saline PlaceboPlacebo ComparatorBiological: Saline placebo—- Locations
Locations City Country Facility Recruitment Status TehranIranOrchid Life Department, Orchid Pharmed Company—- Treatments
Treatments Name Arms Type Description SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantSpikoGen COVID-19 VaccineBiologicalSARS-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 armSaline placeboSaline PlaceboBiological0.9% sodium chloride (1 mL); a single intramuscular injection into the deltoid muscle of the non-dominant arm- Public Contacts
- None
- Primary Outcomes
Primary Outcomes Measure Time Frame Description Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies14 days after the booster doseAs measured by ELISA- Secondary Outcomes
Secondary Outcomes Measure Time Frame Description Incidence of solicited adverse eventsFor 7 days after the booster doseInjection 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)Incidence of unsolicited adverse eventsFor 14 days after the booster doseAs 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)Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)For 6 months after the booster doseAs defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)Geometric mean concentration (GMC) for S1 binding IgG antibodiesDays 0, 14, 90, and 180As measured by ELISAGeometric mean fold rise (GMFR) for S1 binding IgG antibodies14 days after the booster doseAs measured by ELISAPercentage of participants with seroconversion for S1 binding IgG antibodies14 days after the booster doseAs measured by ELISAPercentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies14 days after the booster doseAs measured by ELISAGeometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodiesDays 0, 14, 90, and 180As measured by ELISAGeometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies14 days after the booster doseAs measured by ELISAGeometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodiesDays 0, 14, 90, and 180As measured by ELISAGeometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies14 days after the booster doseAs measured by ELISAChange in T-cell IFN-γ secretion from baseline to 14 days after the booster doseDays 0 and 14As measured by IGRA
About ClinicalTrials.gov
Search trials finds studies by condition or medicine, with optional location, distance, recruitment status, and phase filters.
Get trial returns a public study record using an NCT number or title, including treatments, arms, locations, and public contacts.
List company trials returns studies for a sponsor, with optional phase, status, and condition filters.
Built by Fous from clinicaltrials.gov and nominatim.openstreetmap.org and checked automatically; it last passed a check on Sep 29, 2026. Fous is not affiliated with ClinicalTrials.gov.
Actions
Get trial
1 credit per runGet the full public record for a clinical trial by NCT number or title. For ambiguous titles, returns the closest matching registered title. Dates without a recorded day are returned as null.
What you provide
| Field | Type | Required | Description |
|---|---|---|---|
Trialtrial | Text | Required | The trial title or NCT trial number, for example NCT04368728.Example: NCT05175625 |
What you get
| Field | Type | Description |
|---|---|---|
Armsarms | List | |
Namearms[].name | Text | Example: SpikoGen COVID-19 Vaccine |
Typearms[].type | Text | Example: Experimental |
Treatmentsarms[].treatments | List | |
Descriptionarms[].description | Text | |
Phasephase | Text | Example: Phase 3 |
Titletitle | Text | Example: Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine |
Statusstatus | Text | Example: Completed |
Sponsorsponsor | Text | Example: Cinnagen |
Age Rangeage_range | Text | Example: 18 Years and older |
Locationslocations | List | |
Citylocations[].city | Text | Example: Tehran |
Countrylocations[].country | Text | Example: Iran |
Facilitylocations[].facility | Text | Example: Orchid Life Department, Orchid Pharmed Company |
Recruitment Statuslocations[].recruitment_status | Text | |
Start Datestart_date | Date | Example: 2021-12-15 |
Treatmentstreatments | List | |
Armstreatments[].arms | List | |
Nametreatments[].name | Text | Example: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant |
Typetreatments[].type | Text | Example: Biological |
Descriptiontreatments[].description | Text | Example: SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg); a… |
Trial Linktrial_link | Text | Example: https://clinicaltrials.gov/study/NCT05175625 |
Trial Numbertrial_number | Text | Example: NCT05175625 |
Official Titleofficial_title | Text | Example: A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group… |
Results Postedresults_posted | Yes or no | Example: No |
Completion Datecompletion_date | Date | Example: 2022-06-20 |
Public Contactspublic_contacts | List | |
Namepublic_contacts[].name | Text | |
Rolepublic_contacts[].role | Text | |
Emailpublic_contacts[].email | Text | |
Phonepublic_contacts[].phone | Text | |
Facilitypublic_contacts[].facility | Text | |
Purpose Summarypurpose_summary | Text | |
Primary Outcomesprimary_outcomes | List | |
Measureprimary_outcomes[].measure | Text | Example: Percentage of participants with seroconversion for SARS-CoV-2 neutralizing… |
Time Frameprimary_outcomes[].time_frame | Text | Example: 14 days after the booster dose |
Descriptionprimary_outcomes[].description | Text | Example: As measured by ELISA |
Secondary Outcomessecondary_outcomes | List | |
Measuresecondary_outcomes[].measure | Text | Example: Incidence of solicited adverse events |
Time Framesecondary_outcomes[].time_frame | Text | Example: For 7 days after the booster dose |
Descriptionsecondary_outcomes[].description | Text | Example: Injection site pain, erythema, swelling, and induration, axillary swelling or… |
Eligibility Criteriaeligibility_criteria | Text | |
Number of Participantsnumber_of_participants | Number | Example: 300 |
Example result
For Trial: NCT05175625
{
"arms": [
{
"name": "SpikoGen COVID-19 Vaccine",
"type": "Experimental",
"treatments": [
"Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant"
],
"description": null
}
],
"phase": "Phase 3",
"title": "Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine",
"status": "Completed",
"sponsor": "Cinnagen",
"age_range": "18 Years and older",
"locations": [
{
"city": "Tehran",
"country": "Iran",
"facility": "Orchid Life Department, Orchid Pharmed Company",
"recruitment_status": null
}
],
"start_date": "2021-12-15",
"treatments": [
{
"arms": [
"SpikoGen COVID-19 Vaccine"
],
"name": "SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant",
"type": "Biological",
"description": "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"
}
],
"trial_link": "https://clinicaltrials.gov/study/NCT05175625",
"trial_number": "NCT05175625",
"official_title": "A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19…",
"results_posted": false,
"completion_date": "2022-06-20",
"public_contacts": [],
"purpose_summary": "This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subu…",
"primary_outcomes": [
{
"measure": "Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies",
"time_frame": "14 days after the booster dose",
"description": "As measured by ELISA"
}
],
"secondary_outcomes": [
{
"measure": "Incidence of solicited adverse events
…List company trials
1 credit per runList studies run or funded by a sponsor, newest start date first. Dates without a full day are returned as null.
What you provide
| Field | Type | Required | Description |
|---|---|---|---|
Phasephase | Text | Optional | Study phase to include, such as phase_3; any includes all phases.Example: Phase 3 |
Statusstatus | Text | Optional | Study recruitment status, such as recruiting; any includes all statuses.Example: Recruiting |
Sponsorsponsor | Text | Required | Company or organization sponsoring or collaborating on studies, such as Pfizer.Example: Pfizer |
Conditioncondition | Text | Optional | Condition to match, such as obesity.Example: Obesity |
Max Resultsmax_results | Number | Optional | Maximum number of studies to return, such as 50 (up to 200).Example: 10 |
What you get
| Field | Type | Description |
|---|---|---|
Trialstrials | List | Matching trials sorted by start date, newest first. |
Phasetrials[].phase | Text | Study phase or phases in words.Example: Phase 3 |
Statustrials[].status | Text | Overall study status in words.Example: Recruiting |
Conditionstrials[].conditions | List | Conditions studied. |
Start Datetrials[].start_date | Text | Start date as YYYY-MM-DD when the day is known.Example: 2026-06-10 |
Trial Linktrials[].trial_link | Text | ClinicalTrials.gov study page.Example: https://clinicaltrials.gov/study/NCT07595549 |
Trial Titletrials[].trial_title | Text | Public study title.Example: A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in… |
Trial Numbertrials[].trial_number | Text | NCT study number.Example: NCT07595549 |
Number of Participantstrials[].number_of_participants | Number | Enrolled or planned number of participants.Example: 954 |
Primary Completion Datetrials[].primary_completion_date | Text | Primary completion date as YYYY-MM-DD when the day is known.Example: 2028-05-04 |
Example result
For Phase: Phase 3, Status: Recruiting, Sponsor: Pfizer, Condition: Obesity, Max Results: 10
{
"trials": [
{
"phase": "Phase 3",
"status": "Recruiting",
"conditions": [
"Obesity",
"Overweight and/or Obesity",
"Overweight"
],
"start_date": "2026-06-10",
"trial_link": "https://clinicaltrials.gov/study/NCT07595549",
"trial_title": "A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity",
"trial_number": "NCT07595549",
"number_of_participants": 954,
"primary_completion_date": "2028-05-04"
}
]
}Search trials
1 credit per runFind ClinicalTrials.gov studies for a condition or medicine, with optional location, distance, recruitment status, and phase filters. With a location, results are ordered by distance to their closest eligible registered site. Site distances are approximate straight-line miles; contact and eligibility information may be missing.
Uses ClinicalTrials.gov and nominatim.openstreetmap.org.
What you provide
| Field | Type | Required | Description |
|---|---|---|---|
Phasephase | Text | Optional | Study phase, for example phase_3 or any.Example: Phase 3 |
Locationlocation | Text | Optional | City, state, or country for nearby trials, for example Boston, MA.Example: Boston, MA |
Conditioncondition | Text | Required | Condition or medicine to search, for example breast cancer or semaglutide.Example: Semaglutide |
Max Resultsmax_results | Number | Optional | Maximum number of trials to return, for example 20 (up to 100).Example: 3 |
Distance (miles)distance_miles | Number | Optional | Search radius in miles when a location is given, for example 50.Example: 50 |
Recruiting Onlyrecruiting_only | Yes or no | Optional | Include only studies recruiting or preparing to recruit, for example true.Example: Yes |
What you get
| Field | Type | Description |
|---|---|---|
Trialstrials | List | |
Sextrials[].sex | Text | Example: All |
Phasetrials[].phase | Text | Example: Not applicable |
Statustrials[].status | Text | Example: Recruiting |
Sponsortrials[].sponsor | Text | Example: University College Dublin |
Age Rangetrials[].age_range | Text | Example: 18 Years and older |
Conditionstrials[].conditions | List | |
Start Datetrials[].start_date | Text | Example: 2022-06-22 |
Trial Linktrials[].trial_link | Text | Example: https://clinicaltrials.gov/study/NCT04174755 |
Trial Titletrials[].trial_title | Text | Example: Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV |
Contact Nametrials[].contact_name | Text | Example: Aoife Cotter, PhD |
Trial Numbertrials[].trial_number | Text | Example: NCT04174755 |
Contact Emailtrials[].contact_email | Text | Example: [email protected] |
Contact Phonetrials[].contact_phone | Text | Example: 562-826-8000 |
Distance (miles)trials[].distance_miles | Number | Example: 0.1 |
Nearest Site Citytrials[].nearest_site_city | Text | Example: Dublin |
Healthy Volunteerstrials[].healthy_volunteers | Yes or no | Example: No |
Nearest Site Statetrials[].nearest_site_state | Text | Example: Dublin |
Nearest Site Countrytrials[].nearest_site_country | Text | Example: Ireland |
Nearest Site Facilitytrials[].nearest_site_facility | Text | Example: Mater Misericordiae University Hospital |
Example result
For Condition: Semaglutide, Max Results: 3
{
"trials": [
{
"sex": "All",
"phase": "Not applicable",
"status": "Recruiting",
"sponsor": "University College Dublin",
"age_range": "18 Years and older",
"conditions": [
"Obesity",
"HIV-1-infection"
],
"start_date": "2022-06-22",
"trial_link": "https://clinicaltrials.gov/study/NCT04174755",
"trial_title": "Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV",
"contact_name": "Aoife Cotter, PhD",
"trial_number": "NCT04174755",
"contact_email": "[email protected]",
"contact_phone": null,
"distance_miles": null,
"nearest_site_city": "Dublin",
"healthy_volunteers": false,
"nearest_site_state": "Dublin",
"nearest_site_country": "Ireland",
"nearest_site_facility": "Mater Misericordiae University Hospital"
},
{
"sex": "All",
"phase": "Phase 3",
"status": "Recruiting",
"sponsor": "VA Office of Research and Development",
"age_range": "18 Years to 80 Years",
"conditions": [
"Alcohol Use Disorder"
],
"start_date": "2026-07-28",
"trial_link": "https://clinicaltrials.gov/study/NCT07218354",
"trial_title": "Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)",
"contact_name": "Larry Albers, MD",
"trial_number": "NCT07218354",
"contact_email": "[email protected]",
"contact_phone": "562-826-8000",
"distance_miles": null,
"nearest_site_city": "Long Beach",
"healthy_volunteers": true,
"nearest_site_state": "California",
"nearest_site_country": "United States",
"nearest_site_facility": "VA Long Beach Healthcare System, Long Beach, CA"
}
]
}For developers
Run this workflow from your own code. In Studio, turn on Developer mode and create an API key.
# First set your key: export FOUS_API_KEY='YOUR_FOUS_API_KEY'
: "${FOUS_API_KEY:?Set FOUS_API_KEY before running this example}"
curl 'https://api.fous.com/v1/query' \
--fail-with-body --silent --show-error --max-time 120 \
-H "Authorization: Bearer $FOUS_API_KEY" \
-H 'Content-Type: application/json' \
--data-raw '{
"api": "@clinicaltrials-gov",
"visibility": "public",
"operation": "get_trial",
"version": 1,
"input": {
"trial": "NCT05175625"
},
"response": {
"format": "json"
}
}'What you can do with it
- Find recruiting trials for a condition near a city
- Review a trial’s treatments, arms, locations, and public contacts
- Compare company studies by phase, status, or condition
- Track study start dates and participant counts by sponsor
Questions
Is Fous affiliated with ClinicalTrials.gov?
No. Fous is not affiliated with ClinicalTrials.gov. This workflow reads the public clinicaltrials.gov website and returns its data.
How much does it cost?
Each run costs 1 credit. With pay-as-you-go, a credit costs 1¢; monthly plans cost less per credit.
Do I need a ClinicalTrials.gov account?
No. You only need a Fous account.
How current is the data?
Fous gets the data from clinicaltrials.gov when you run it; repeating the same request within a day may return the saved result. Fous checks this workflow automatically; it last passed a check on Sep 29, 2026.
Which trials are recruiting near a location?
Search trials finds studies for a condition or medicine and can filter by location, distance, recruitment status, and phase.
What treatments and locations are listed for a trial?
Get trial returns a public record with treatments, study arms, locations, and recruitment status by location.
What studies is a company sponsoring?
List company trials returns studies for a sponsor, with optional filters for phase, status, and condition.