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

NCT05960097
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
692
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Lead sponsor
GlaxoSmithKline
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Start date
2023-08-01
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Number of sites
17
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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.
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Short title
A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
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Official title
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)
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-08-30
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First posted
2023-07-25
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Registry last updated
2025-10-23
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Primary completion date
2024-08-30
clinicaltrials.gov
Start date
2023-08-01
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Actual participants
692
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Participants
692
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
17
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
GlaxoSmithKline
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05960097
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ClinicalTrials.gov ID
NCT05960097
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
This is an observer-blind study.
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein

    Timeframe: At Day 29

  2. Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein

    Timeframe: At Day 29

  3. Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein

    Timeframe: At Day 29

  4. Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)

    Timeframe: Day 1 to Day 7

    Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.

  5. Part A: Number of Participants Reporting Any Solicited Systemic AEs

    Timeframe: Day 1 to Day 7

    Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (\>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.

  6. Part A: Number of Participants Reporting Any Unsolicited AEs

    Timeframe: Day 1 to Day 28

    An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.

  7. Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)

    Timeframe: Day 1 to Day 181

    An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement. An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations. AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. "Any" indicates the occurrence of the event regardless of its intensity grade.

  8. Part B: Number of Participants Reporting Any Solicited Administration Site AEs

    Timeframe: Day 1 to Day 7

    Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.

  9. Part B: Number of Participants Reporting Any Solicited Systemic AEs

    Timeframe: Day 1 to Day 7

    Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature \>= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.

  10. Part B: Number of Participants Reporting Any Unsolicited AEs

    Timeframe: Day 1 to Day 28

    An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.

  11. Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs

    Timeframe: Day 1 to Day 181

  1. Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein

    Timeframe: At Day 91 and Day 181

  2. Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein

    Timeframe: At Day 91 and Day 181

  3. Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein

    Timeframe: At Day 29, Day 91 and Day 181

  4. Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein

    Timeframe: At Day 29 compared to baseline (Day 1)

    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.

  5. Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein

    Timeframe: At Day 29 compared to baseline (Day 1)

    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.

  6. Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein

    Timeframe: At Day 29 compared to baseline (Day 1)

    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.

  7. Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein

    Timeframe: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)

    GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

  8. Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein

    Timeframe: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)

    GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

  9. Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein

    Timeframe: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)

    GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

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.
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteSacramento, United States
  • GSK Investigational SiteHollywood, United States
  • GSK Investigational SitePeoria, United States
  • GSK Investigational SiteBruce, Australia
  • GSK Investigational SiteBlacktown, Australia
  • GSK Investigational SiteBotany, Australia
  • GSK Investigational SiteBrookvale, Australia
  • GSK Investigational SiteCoffs Harbour, Australia
  • GSK Investigational SiteDarlinghurst, Australia
  • GSK Investigational SiteKanwal, Australia
  • GSK Investigational SiteMaroubra, Australia
  • GSK Investigational SiteMerewether, Australia
  • GSK Investigational SiteBlacktown, Australia
  • GSK Investigational SiteSherwood, Australia
  • GSK Investigational SiteTarragindi, Australia
  • GSK Investigational SiteAdelaide, Australia
  • GSK Investigational SiteCamberwell, Australia
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (6)