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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

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant Biological: Saline placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : May 30, 2021
Actual Primary Completion Date : July 19, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccine candidate 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

Placebo Comparator: Saline placebo 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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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)

  26. 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

  27. 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

  28. 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

  29. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944368


Locations
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Iran, Islamic Republic of
Espinas Palace Hotel
Tehran, Iran, Islamic Republic of, 1981846911
Sponsors and Collaborators
Cinnagen
Vaxine Pty Ltd
Investigators
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Principal Investigator: Payam Tabarsi, M.D. Shahid Beheshti University of Medical Sciences
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Responsible Party: Cinnagen
ClinicalTrials.gov Identifier: NCT04944368    
Other Study ID Numbers: VAC.CIN.PT.II
IRCT20150303021315N23 ( Registry Identifier: Iranian Registry of Clinical Trials )
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cinnagen:
COVID-19
SARS-COV-2
Recombinant protein
Spike
Advax-SM
Advax
Vaccine
Adjuvant
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Myeloma Proteins
Paraproteins
Immunologic Factors
Physiological Effects of Drugs