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Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)

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ClinicalTrials.gov Identifier: NCT04944368
Recruitment Status : Active, not recruiting
First Posted : June 29, 2021
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
Vaxine Pty Ltd
Information provided by (Responsible Party):
Cinnagen

Tracking Information
First Submitted Date  ICMJE June 19, 2021
First Posted Date  ICMJE June 29, 2021
Last Update Posted Date October 11, 2021
Actual Study Start Date  ICMJE May 30, 2021
Actual Primary Completion Date July 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2021)
  • Incidence of solicited adverse events [ Time Frame: For 7 days after each dose ]
    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)
  • Incidence of unsolicited adverse events [ Time Frame: For 28 days after each dose ]
    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)
  • Percentage of participants with seroconversion for S-protein binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for S-protein binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Change in geometric mean concentration (GMC) for S-protein binding IgG antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean concentration (GMC) for S-protein binding IgG antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2021)
  • Incidence of solicited adverse events [ Time Frame: For 7 days after each dose ]
    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)
  • Incidence of unsolicited adverse events [ Time Frame: For 28 days after each dose ]
    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)
  • Percentage of participants with seroconversion for S-protein binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for S-protein binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for S-protein binding IgG antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for S-protein binding IgG antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2021)
  • Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA (sVNT)
  • Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by cVNT
  • Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA (sVNT)
  • Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by cVNT
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Percentage of participants with seroconversion for S-protein binding IgA antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for S-protein binding IgA antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA (sVNT)
  • Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA (sVNT)
  • Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA (sVNT)
  • Change in geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA (sVNT)
  • Change in geometric mean concentration (GMC) for S-protein binding IgA antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean concentration (GMC) for S-protein binding IgA antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgA antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgA antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) [ Time Frame: For 6 months after the second dose ]
    As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
  • Change in T-cell proliferation responses from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
  • Change in T-cell proliferation responses from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
  • Change in T-cell IFN-γ secretion from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by IGRA
  • Change in T-cell IFN-γ secretion from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by IGRA
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2021)
  • Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgA antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Percentage of participants with seroconversion for S-protein binding IgA antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for S-protein binding IgA antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for receptor-binding domain (RBD) binding IgG antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for receptor-binding domain (RBD) binding IgA antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for receptor-binding domain (RBD) binding IgA antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgA antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgA antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for S-protein binding IgA antibodies from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Change in geometric mean titer (GMT) for S-protein binding IgA antibodies from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgA antibodies after the first injection [ Time Frame: 21 days after the first dose (on the day of the second dose) ]
    As measured by ELISA
  • Geometric mean fold rise (GMFR) for S-protein binding IgA antibodies after the second injection [ Time Frame: 14 days after the second dose ]
    As measured by ELISA
  • Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) [ Time Frame: For 6 months after the second dose ]
    As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
  • Change in T-cell proliferation responses from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
  • Change in T-cell proliferation responses from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    Evaluation of CD4+ and CD8+ T-cell proliferation responses as measured by flow cytometry
  • Change in T-cell cytokine secretion from baseline to 21 days after the first injection [ Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose) ]
    Evaluation of the frequency of T-cells secreting IFN-γ in response to spike protein stimulation as measured by flow cytometry and intracellular cytokine staining
  • Change in T-cell cytokine secretion from baseline to 14 days after the second injection [ Time Frame: On the day of the first dose and 14 days after the second dose ]
    Evaluation of the frequency of T-cells secreting IFN-γ in response to spike protein stimulation as measured by flow cytometry and intracellular cytokine staining
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
Official Title  ICMJE A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)
Brief Summary

This is a phase II, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and immunogenicity of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. 400 adult individuals receive either SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) or saline placebo in a 3:1 ratio. The injection is given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The randomization was stratified by age (<65 or ≥65) and health conditions of potential risk for severe COVID-19. Participants will be visited at two weeks and will be followed up for six months after the second dose of the study intervention.

Study hypotheses include:

  1. The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.
  2. The adjuvanted COVID-19 vaccine candidate induces strong immunogenicity against SARS-CoV-2 in adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
    SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
    Other Name: SpikoGen
  • Biological: Saline placebo
    0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: Vaccine candidate
    Intervention: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
  • Placebo Comparator: Saline placebo
    Intervention: Biological: Saline placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 28, 2021)
400
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Actual Primary Completion Date July 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Females must not be pregnant or breastfeeding

Exclusion Criteria:

  • Subjects with signs of active SARS-COV-2 infection at the screening visit.
  • Subjects with body temperature of 38 degrees Celsius or greater at the screening visit or within 72 hours prior to the screening visit.
  • Subjects with a history of any progressive or severe neurological disorders, seizure, or Guillain-Barre syndrome.
  • Subjects who receive immunosuppressive or cytotoxic medications.
  • Female Subjects who are pregnant or breastfeeding or have planned to become pregnant during the study period.
  • 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 been vaccinated with any vaccine or vaccine candidate against SARS-CoV-2.
  • Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to 14 days after the second dose of the study injection.
  • Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04944368
Other Study ID Numbers  ICMJE VAC.CIN.PT.II
IRCT20150303021315N23 ( Registry Identifier: Iranian Registry of Clinical Trials )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cinnagen
Study Sponsor  ICMJE Cinnagen
Collaborators  ICMJE Vaxine Pty Ltd
Investigators  ICMJE
Principal Investigator: Payam Tabarsi, M.D. Shahid Beheshti University of Medical Sciences
PRS Account Cinnagen
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP