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A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05960097
Recruitment Status : Active, not recruiting
First Posted : July 25, 2023
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
CureVac
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 24, 2023
First Posted Date  ICMJE July 25, 2023
Last Update Posted Date March 15, 2024
Actual Study Start Date  ICMJE August 1, 2023
Estimated Primary Completion Date August 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2024)
  • Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Day 29 ]
  • Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Day 29 ]
  • Part A: Percentage of participants with solicited administration site adverse events (AEs) [ Time Frame: Day 1 to Day 7 ]
  • Part A: Percentage of participants with solicited administration systemic AEs [ Time Frame: Day 1 to Day 7 ]
  • Part A: Percentage of participants with unsolicited AEs [ Time Frame: Day 1 to Day 28 ]
  • Part A: Percentage of participants with medically attended adverse events (MAAEs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Part A: Percentage of participants with serious adverse events (SAEs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Part A: Percentage of participants with adverse events of special interest (AESIs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Part B: Percentage of participants with solicited administration site adverse events (AEs) [ Time Frame: Day 1 to Day 7 ]
  • Part B: Percentage of participants with solicited administration systemic AEs [ Time Frame: Day 1 to Day 7 ]
  • Part B: Percentage of participants with unsolicited AEs [ Time Frame: Day 1 to Day 28 ]
  • Part B: Percentage of participants with medically attended adverse events (MAAEs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Part B: Percentage of participants with serious adverse events (SAEs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Part B: Percentage of participants with adverse events of special interest (AESIs) Part B: Percentage of participants with adverse events of special interest (AESIs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Part B: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Day 29 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2023)
  • Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Day 29 ]
  • Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Day 29 ]
  • Percentage of participants with solicited administration site adverse events (AEs) [ Time Frame: Day 1 to Day 7 ]
  • Percentage of participants with solicited administration systemic AEs [ Time Frame: Day 1 to Day 7 ]
  • Percentage of participants with unsolicited AEs [ Time Frame: Day 1 to Day 28 ]
  • Percentage of participants with medically attended adverse events (MAAEs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Percentage of participants with serious adverse events (SAEs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
  • Percentage of participants with adverse events of special interest (AESIs) [ Time Frame: Day 1 through End of Study (approximately 180 days after the study intervention administration) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2024)
  • Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Day 91 and Day 181 ]
  • Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Day 91 and Day 181 ]
  • Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein [ Time Frame: Days 29, 91 and 181 ]
  • Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Day 29 ]
    Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
  • Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Day 29 ]
    Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
  • Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein [ Time Frame: Day 29 ]
    Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
  • Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Days 29, 91 and 181 ]
  • Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Days 29, 91 and 181 ]
  • Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein [ Time Frame: Days 29, 91 and 181 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2023)
  • Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Day 91 and Day 181 ]
  • Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Day 91 and Day 181 ]
  • Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein [ Time Frame: Days 29, 91 and 181 ]
  • Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Day 29 ]
    Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
  • Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Day 29 ]
    Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
  • Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein [ Time Frame: Day 29 ]
    Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
  • Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein [ Time Frame: Days 29, 91 and 181 ]
  • Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein [ Time Frame: Days 29, 91 and 181 ]
  • Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein [ Time Frame: Days 29, 91 and 181 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
Official Title  ICMJE A Phase 2 Randomized, Active-controlled, Observer-blind Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Booster Dose of Investigational COVID-19 mRNA Vaccines in Healthy Adults Who Previously Received a Complete Primary Vaccination Series With or Without Booster Dose(s)
Brief Summary

The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine.

The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
This is an observer-blind study.
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Biological: CV0701 Bivalent High dose
    Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
  • Biological: CV0701 Bivalent Medium dose
    Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
  • Biological: CV0701 Bivalent Low dose
    Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
  • Biological: CV0601 Monovalent High dose
    Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
  • Biological: Control vaccine
    Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
  • Biological: CV0801 Monovalent
    Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
Study Arms  ICMJE
  • Experimental: Part A, Group A: CV0701 High dose
    Participants receive high dose of CV0701.
    Intervention: Biological: CV0701 Bivalent High dose
  • Experimental: Part A, Group B: CV0701 Medium dose
    Participants receive medium dose of CV0701.
    Intervention: Biological: CV0701 Bivalent Medium dose
  • Experimental: Part A, Group C: CV0701 Low dose
    Participants receive low dose of CV0701.
    Intervention: Biological: CV0701 Bivalent Low dose
  • Experimental: Part A, Group D: CV0601 High dose
    Participants receive high dose of CV0601.
    Intervention: Biological: CV0601 Monovalent High dose
  • Active Comparator: Part A, Group E: Control vaccine
    Participants receive control vaccine.
    Intervention: Biological: Control vaccine
  • Experimental: Part B, Condition 1: Baseline-control
    Participants receive one dose of CV0801.
    Intervention: Biological: CV0801 Monovalent
  • Experimental: Part B, Condition 2: Intermediate storage
    Participants receive one dose of CV0801.
    Intervention: Biological: CV0801 Monovalent
  • Experimental: Part B, Condition 3: Maximum storage conditions
    Participants receive one dose of CV0801.
    Intervention: Biological: CV0801 Monovalent
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: March 13, 2024)		 675
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2023)		 415
Estimated Study Completion Date  ICMJE August 28, 2024
Estimated Primary Completion Date August 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Is at least 18 years old and has achieved legal age according to local regulations in each participating country.
  2. Must provide documented informed consent prior to any study procedures being performed.
  3. Can and will comply with the requirements of the protocol, in the opinion of the investigator.
  4. Is healthy or medically stable as determined by the investigator's judgment based on medical history, vital sign measurements, and physical examination findings. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
  5. Prior receipt of an mRNA COVID-19 vaccine. This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine. The last vaccination must be an mRNA COVID-19 vaccination received at least 3 months prior to randomization.

  6. If the participant is a woman of childbearing potential, the participant may be enrolled in the study, if they:

    • have practiced adequate contraception for 30 days prior to study intervention administration; and
    • have a negative pregnancy test result on the day of study intervention administration; and
    • have agreed to continue adequate contraception for 2 months after study intervention administration.

Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as current salpingectomy, hysterectomy, ovariectomy, or postmenopausal.

Participants are excluded from the study if any of the following criteria apply:

  1. Is pregnant or has a positive pregnancy test result at Visit 1.
  2. Is breastfeeding or will (re)start breastfeeding from the study intervention administration to 3 months after study intervention administration.
  3. Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol or may interfere with successful completion of the study.
  4. Has any history of an immunosuppressive or immunodeficient condition resulting from disease.
  5. Has used immunosuppressants or other immune-modifying drugs for 14 consecutive days or more within 3 months prior to the study intervention administration. Non-systemic corticosteroids are allowed. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration.
  6. Has an acute medical illness or acute febrile illness with oral temperature ≥38.0°C or ≥100.4°F within 72 hours prior to study intervention administration.
  7. Has participated in another study involving any investigational product, vaccine, or device within 28 days before the study intervention administration and/or planned participation through end of study (EoS).
  8. Has participated in Part A of this study.
  9. Has a history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reactions to any previous mRNA vaccine or any component of the study intervention(s).
  10. Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before study intervention administration through EoS.
  11. Has a bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections.
  12. Has a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
  13. Has a history of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
  14. Has received a live vaccine 30 days before the study intervention administration or has a planned administration within 30 days after the study intervention administration.
  15. Has received a non-replicating vaccine 8 days before the study intervention administration or has a planned administration within 14 days after the study intervention administration.
  16. Has a documented history of confirmed SARS-CoV-2 infection within 3 months before study intervention administration.
  17. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study intervention administration.
  18. Is an employee or family member of the investigator or study site staff.
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 Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05960097
Other Study ID Numbers  ICMJE 219075
2023-504596-25-00 ( Other Identifier: EU CT number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
URL: http://www.gsk.com/en-gb/innovation/trials/data-transparency/
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE CureVac
Investigators  ICMJE Not Provided
PRS Account GlaxoSmithKline
Verification Date March 2024

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