Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over

Phase
Phase 1/Phase 2
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Dynavax Technologies Corporation
Start date
Number of sites

Summary
This is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational HZ vaccine (Z-1018) in approximately 764 healthy adults.
Short title
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
Official title
A Phase 1/2 Randomized, Observer-Blinded, Active-Controlled, Dose, Escalation Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Participants 50 Years of Age and Over

Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Phase 1/Phase 2
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Randomisation ratio
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Dynavax Technologies Corporation
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. Part 1 and Part 2: Percentage of participants with solicited local and systemic post-injection reactions (PIRs)

    Timeframe: Up to 7 days following each dose

    Solicited local and systemic post-injection reactions (PIRs)

  2. Part 1 and Part 2: Percentage of participants with Adverse events (AEs)

    Timeframe: 28 days following each dose

    Adverse events (AEs)

  3. Part 1 and Part 2: Percentage of participants with serious adverse events (SAEs), medically-attended adverse events (MAEs), and immune-mediated adverse events of special interest (imAESIs)

    Timeframe: Day 1 through 12 months after the last dose of study injection

    Serious adverse events (SAEs) Medically-attended adverse events (MAEs) Immune-mediated adverse events of special interest (imAESIs)

  4. Part 2: Vaccine response

    Timeframe: 4 weeks after the second study injection

    Composite vaccine response rate in glycoprotein E (gE) -specific CD4+ T cells and anti-gE IgG antibodies in the Per Protocol (PP) population

  5. Part 2: Anti-gE IgG antibody concentration

    Timeframe: 4 weeks after the second study injection

    Geometric mean concentration (GMC) and geometric mean ratio of IgG antibodies to varicella-zoster virus (VZV) antigen-gE in the Per Protocol (PP) population

  1. Part 1: GMC of IgG antibodies to VZV antigen-gE 4 weeks after the second study injection

    Timeframe: 4 weeks after the second study injection

    GMC to VZV gE in the Per Protocol (PP) population

  2. Part 1: Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE

    Timeframe: 4 weeks after the second study injection

    Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population

  3. Part 1: Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE

    Timeframe: 4 weeks after the second study injection

    Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population

  4. Part 1 and Part 2: Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE

    Timeframe: 4 weeks after the second study injection

    Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE in the Per Protocol (PP) population

  5. Part 2: VRR for gE-specific CD4+ T cells

    Timeframe: 4 weeks after second study injection

    VRR for gE-specific CD4+ T cells in the Per Protocol (PP) population

Sources for outcomes

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

  1. Willing to participate; informed consent provided for the study
  2. Male or female ≥ 50 years of age (Part 1: 50 through 69 years of age, inclusive; Part 2: ≥ 70 years of age
  3. In good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
  4. Able to comprehend and follow all required trial procedures and be available for all visits scheduled in the trial
  5. Seronegative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) as assessed during Screening
  6. If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through 3 months following the final study injection.

  1. History of HZ

  2. Previous vaccination against varicella (chicken pox) or HZ

  3. Febrile illness within 7 days of the first trial injection (defined as at least 1 measured body temperature of ≥ 38°C, regardless of route of measurement)

  4. Confirmed SARS-CoV-2/COVID-19 infection as assessed during Screening within 7 days of first trial injection.

  5. If female of childbearing potential, is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy or to breastfeed

  6. Known or suspected immunodeficiency (including but not limited to HIV/AIDS), or immunocompromised state, as assessed by medical history, past or current laboratory studies, and/or physical examination

  7. History of sensitivity to any component of the trial vaccines

  8. Has received the following prior to Day 1 trial injection:

    a) ≤ 14 days: i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG)

    b) ≤ 28 days: i) Any live vaccine ii) Systemic corticosteroids (≥ 20 mg/ day of prednisone or equivalent for more than 14 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids iii) Any investigational medicinal agent

    c) ≤ 90 days: i) Granulocyte or granulocyte-macrophage colony-stimulating factor ii) Immunoglobulins or any blood products (receipt of certain monoclonal antibodies may on a case-by-case basis be non-exclusionary if approved via consultation with Sponsor Medical Monitor) iii) Antisense oligonucleotides iv) Drugs/investigational agents with very long half-lives (defined as ≥ 60 days) (eg, radioactive iodine-125, amiodarone, nirsevimab, and evinacumab) v) Infusion of blood products

    d) ≤ 6 months before Day 1 (or likely to require during the trial period): i) chronic administration of immunosuppressants or other immune-modifying drugs

    e) At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells

  9. Is undergoing chemotherapy or expected to receive chemotherapy during the trial period; and/or has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin

  10. History or current evidence of any condition, therapy, laboratory abnormality, or other finding that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

  11. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a healthcare provider that might affect the immune response to vaccine (eg, diabetes mellitus, chronic kidney disease)

  12. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial

  13. Current or historical autoimmune disease

  14. Any skin condition and/or tattoo on both arms that may interfere with the evaluation of safety at the injection site, in the opinion of the treating investigator

  15. Any other finding that the Investigator considers will make the participant unsuitable for the trial or unable to comply with the trial requirements

Sources for eligibility

  • Paratus Clinical Research Western SyndneyBlacktown, Australia
  • Emeritus ResearchBotany, Australia
  • Canopy Clinical Northern BeachesBrookvale, Australia
  • Paratus Clinical Research Central CoastKanwal, Australia
  • Sutherland Shire Clinical ResearchMiranda, Australia
  • Innovate Clinical ResearchWaitara, Australia
  • Canopy Clinical WollongongWollongong, Australia
  • Paratus Clinical Research BrisbaneHerston, Australia
  • Veritus ResearchBayswater, Australia
  • Emeritus ResearchCamberwell, Australia
  • Doherty Clinical Trials LimitedEast Melbourne, Australia
  • Optimal Clinical Trials Ltd - NorthAuckland, New Zealand
  • Optimal Clinical Trials Ltd - CentralAuckland, New Zealand
  • New Zealand Clinical ResearchChristchurch, New Zealand
  • Momentum WellingtonWellington, New Zealand
  • Momentum Clinical Research KapitiWellington, New Zealand
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)