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OpenTrials
Completed

NCT Number: NCT05285384

Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine

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:

1. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine. 2. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaheed Labbafinezhad Hospital

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years
  • Willing and able to comply with all study requirements, including scheduled visits, intervention, and laboratory tests
  • Kidney transplant recipients who had received two doses of Sinopharm vaccine after transplantation
  • Females must not be pregnant or breastfeeding
  • At least six months should have passed from the time of transplantation
  • Between 1 to 3 months should have passed from the second dose of Sinopharm vaccine

Exclusion criteria

  • Subjects with signs of active SARS-CoV-2 infection at the screening visit
  • Subjects with a history of SARS-CoV-2 infection based on a positive PCR test result after the second dose of the primary vaccination
  • Subjects with an active CMV infection that requires treatment
  • Subjects who have received rituximab within 6 months prior to the screening visit
  • Subjects who have received intravenous immune globulin (IVIG) within 6 months prior to the screening visit
  • 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 experienced transplant rejection within 30 days prior to the screening visit
  • 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.

Treatment and study plan

SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

Biological

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

Other names: SpikoGen, COVAX-19

Primary outcomes

  1. Percentage of participants with seroconversion for S1 binding IgG antibodies

    Time frame: One month after the booster dose

    As measured by ELISA

  2. Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies

    Time frame: One month after the booster dose

    As measured by ELISA

Secondary outcomes

  1. Geometric mean fold rise (GMFR) for S1 binding IgG antibodies

    Time frame: One month after the booster dose

    As measured by ELISA

  2. Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline

    Time frame: One month after the booster dose

    As measured by ELISA

  3. Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline

    Time frame: One month after the booster dose

    As measured by ELISA

  4. Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies

    Time frame: One month after the booster dose

    As measured by ELISA

  5. Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline

    Time frame: One month after the booster dose

    As measured by ELISA

  6. Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline

    Time frame: One month after the booster dose

    As measured by ELISA

  7. Change in T-cell IFN-γ secretion from baseline to one month after the booster dose

    Time frame: Baseline and one month after the booster dose

    As measured by IGRA

  8. Incidence of solicited adverse events

    Time frame: For 7 days after the booster 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)

  9. Incidence of unsolicited adverse events

    Time frame: For one month after the booster 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)

Sponsors and collaborators

Lead sponsor

Cinnagen

Industry

Collaborators

  • Shahid Beheshti University of Medical Sciences
  • Vaxine Pty Ltd

Registry information

Official study title

An Open-Label, Single-Arm Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Kidney Transplant Recipients After Two Doses of Sinopharm COVID-19 Vaccine

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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