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Study of GRT-R910 COVID-19 Boost Vaccine in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05148962
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
Gritstone bio, Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2021
First Posted Date  ICMJE December 8, 2021
Last Update Posted Date August 8, 2022
Actual Study Start Date  ICMJE September 16, 2021
Estimated Primary Completion Date January 18, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2022)
  • Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms [ Time Frame: Up to 7 days after each vaccination ]
  • Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms [ Time Frame: Up to 7 days after each vaccination ]
  • Number of Participants with One or More Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days after each vaccination ]
  • Change from Baseline for Clinical Safety Laboratory Parameters [ Time Frame: Up to 7 days after each vaccination ]
  • Number of Participants with One or More Serious Adverse Events [ Time Frame: Up to ~16 months after each vaccination ]
  • Number of Participants with One or More Adverse Events of Special Interest (AESIs) Including Potentially Immune-Mediated Medical Condition (PIMMCs), Medically Attended Adverse Events (MAAEs) and New Onset Chronic Medical Condition (NOCMCs) [ Time Frame: Up to ~16 months after each vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2021)
  • Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms [ Time Frame: Up to 7 days after vaccination ]
  • Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms [ Time Frame: Up to 7 days after vaccination ]
  • Number of Participants with One or More Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days after vaccination ]
  • Change from Baseline for Clinical Safety Laboratory Parameters [ Time Frame: Up to 7 days after vaccination ]
  • Number of Participants with One or More Serious Adverse Events [ Time Frame: Up to ~16 months after vaccination ]
  • Number of Participants with One or More Adverse Events of Special Interest (AESIs) Including Potentially Immune-Mediated Medical Condition (PIMMCs), Medically Attended Adverse Events (MAAEs) and New Onset Chronic Medical Condition (NOCMCs) [ Time Frame: Up to ~16 months after vaccination ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2022)
  • Response Rate and magnitude of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples [Time Frame: Up to ~16 months after the prime vaccinationSerum Samples [ Time Frame: Up to ~16 months after prime vaccination ]
  • Response Rate, magnitude, and breath of SARS-CoV-2 Specific T-Cells by Interferon-gamma (IFN-γ) Enzyme-Linked Immunospot (IFN-γ ELISpot) Assay [ Time Frame: Up to ~16 months after prime vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2021)
  • Response Rate of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples [ Time Frame: Up to ~16 months after vaccination ]
  • Magnitude of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples [ Time Frame: Up to ~16 months after vaccination ]
  • Response Rate of SARS-CoV-2 Specific T-Cells by Interferon-gamma Enzyme-Linked Immunospot (IFN-γ ELISpot) Assay [ Time Frame: Up to ~16 months after vaccination ]
  • Magnitude of SARS-CoV-2 Specific T-Cell Response by Interferon-gamma Enzyme-Linked Immunospot (IFN-γ ELISpot) Assay [ Time Frame: Up to ~16 months after vaccination ]
  • Breadth of SARS-CoV-2 Specific T-Cell Response by Interferon-gamma Enzyme-Linked Immunospot (IFN-γ ELISpot) Assay [ Time Frame: Up to ~16 months after vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of GRT-R910 COVID-19 Boost Vaccine in Healthy Volunteers
Official Title  ICMJE A Phase 1 Trial to Evaluate the Safety, Immunogenicity, and Reactogenicity of a Self-Amplifying mRNA Prophylactic Vaccine Boost Against SARS-CoV-2 in Previously Vaccinated Healthy Adults 18 Years and Older
Brief Summary The primary objective is to assess the safety and tolerability of 2 different doses (10 or 30 mcg) of GRT-R910 when administered as a boost in healthy adults previously vaccinated with the AstraZeneca, Janssen/Johnson and Johnson, Moderna, or Pfizer/BioNTech COVID-19 vaccines.
Detailed Description This trial will study a self-amplifying mRNA (samRNA) based vaccine (GRT-R910) in previously vaccinated adults (≥18 years). GRT-R910 uses a codon optimized, prefusion stabilized Spike (S) cassette with additional T cell epitopes (TCEs) covering multiple epitopes from non-spike proteins to safely drive strong, broad, and durable B and T cell immune responses to SARS-CoV-2.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: GRT-R910 10 mcg Dose (after AZ)
    10 mcg vaccine by intramuscular (IM) injection on Day 1 (required) and on Day 113 (optional)
  • Biological: GRT-R910 30 mcg Dose (after AZ)
    30 mcg vaccine by intramuscular (IM) injection on Day 1 (required) and on Day 113 (optional)
  • Biological: GRT-R910 10 mcg Dose (After Adenovirus based vaccine)
    GRT-R910 10 mcg vaccine by intramuscular (IM) injection on Day 1 and on Day 29
  • Biological: GRT-R910 10 mcg Dose (after mRNA based vaccine)
    GRT-R910 10 mcg vaccine by intramuscular (IM) injection on Day 1 and on Day 29
Study Arms  ICMJE
  • Experimental: 1 or 2 Doses of 10 mcg GRT-R910 after AstraZeneca Standard of Care
    Healthy adults ≥60 years of age receive up to 2 doses of 10 mcg GRT-R910 homologous prime-boost
    Intervention: Biological: GRT-R910 10 mcg Dose (after AZ)
  • Experimental: Cohort 2: 1 or 2 Doses of 30 mcg GRT-R910 after AstraZeneca Standard of Care
    Healthy adults ≥60 years of age receive up to 2 doses of 30 mcg GRT-R910 homologous prime-boost
    Intervention: Biological: GRT-R910 30 mcg Dose (after AZ)
  • Experimental: Cohort 3: 2 Doses 10 mcg GRT-R910 after Adenovirus-Based Vector Vaccine Standard of Care
    Healthy adults ≥60 years of age receive 2 doses of 10 mcg GRT-R910 homologous prime-boost
    Intervention: Biological: GRT-R910 10 mcg Dose (After Adenovirus based vaccine)
  • Experimental: Cohort 4: 2 Doses 10 mcg GRT-R910 after mRNA Vaccine Standard of Care
    Healthy adults ≥60 years of age receive 2 doses of 10 mcg GRT-R910 homologous prime-boost
    Intervention: Biological: GRT-R910 10 mcg Dose (after mRNA based vaccine)
  • Experimental: Cohort 5: 2 Doses 10 mcg mcg GRT-R910 after Adenovirus-Based Vector Vaccine Standard of Care
    Healthy adults ≥18 to ≤59 years of age receive 2 doses of 10 mcg GRT-R910 homologous prime-boost
    Intervention: Biological: GRT-R910 10 mcg Dose (After Adenovirus based vaccine)
  • Experimental: Cohort 6: 2 Doses 10 mcg GRT-R910 after mRNA Vaccine Standard of Care
    Healthy adults ≥18 to ≤59 years of age receive 2 doses of 10 mcg GRT-R910 homologous prime-boost
    Intervention: Biological: GRT-R910 10 mcg Dose (after mRNA based vaccine)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2021)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 18, 2024
Estimated Primary Completion Date January 18, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • For Cohorts 1 and 2, have received AstraZeneca's COVID-19 prime and boost vaccine at least 2 months prior to study participation.
  • For Cohorts 3 and 5, have previously received Janssen/Johnson and Johnson or AstraZeneca vaccine with or without booster dose(s) of an authorized vaccine at least 2 months prior to Day 1.
  • For Cohorts 4 and 6, have previously received an mRNA COVID-19 vaccine with or without booster dose(s) of an authorized vaccine with the last dose received at least 2 months prior to Day 1.
  • Agree to refrain from blood donation during the course of the study.
  • Women of childbearing potential (WOCBP)* must agree to avoid pregnancy and be willing to use a highly effective method of contraception** consistently for 30 days prior to the first study vaccine and for at least 60 days after the last study vaccine
  • Male participants of childbearing potential must agree to the use of condoms to ensure effective contraception with a female partner from the time of study vaccination until 3 months after vaccination.
  • Plan to remain living in the area for the duration of the study.

Exclusion Criteria:

  • History of prior confirmed COVID-19 (cohorts 1 and 2).
  • Positive for SARS-CoV-2 by lateral flow test (rapid diagnostic test), enzyme-linked immunosorbent assay (ELISA) or by nasal swab polymerase chain reaction (PCR) at screening (Cohorts 3-6).
  • Prior receipt of a SARS-CoV-2 vaccine other than AstraZeneca's AZD1222 (Covishield®, Vaxzevria®), approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with a lipid nanoparticle (LNP) component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data.
  • On current treatment or prevention agents with activity against SARS-CoV-2.
  • Participation in another research study involving receipt of an investigational product in the 60 days preceding enrollment or planned use during the study period.
  • Receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination.
  • Receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of first study vaccination or at any time during the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient state.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain.
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Any history of anaphylaxis, including but not limited to reaction to vaccination.
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • History of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation.
  • Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.
  • Suspected or known current alcohol abuse that in the opinion of the investigator would impede compliance with the protocol and schedules of assessments.
  • Suspected or known drug abuse in the 5 years preceding enrollment.
  • Any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.
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: Dan Koralek, Ph.D 1-(877)-520-2233 clinicalstudies@gritstone.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05148962
Other Study ID Numbers  ICMJE GO-009
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Gritstone bio, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gritstone bio, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dan Koralek, Ph.D Gritstone bio, Inc.
PRS Account Gritstone bio, Inc.
Verification Date August 2022

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