RecruitingPhase 1/2

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

Australia764 participantsStarted 2024-06-17

Plain-language 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.

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing to participate; informed consent provided for the study
✓. Male or female ≥ 50 years of age (Part 1: 50 through 69 years of age, inclusive; Part 2: ≥ 70 years of age
✓. In good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
✓. Able to comprehend and follow all required trial procedures and be available for all visits scheduled in the trial
✓. Seronegative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) as assessed during Screening
✓. 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.

Exclusion criteria

✕. History of HZ
✕. Previous vaccination against varicella (chicken pox) or HZ
✕. 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)
✕. Confirmed SARS-CoV-2/COVID-19 infection as assessed during Screening within 7 days of first trial injection.
✕. If female of childbearing potential, is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy or to breastfeed

What they're measuring

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

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

Timeframe: 28 days following each dose

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

Part 2: Vaccine response

Timeframe: 4 weeks after the second study injection

Part 2: Anti-gE IgG antibody concentration

Timeframe: 4 weeks after the second study injection

Trial details

NCT IDNCT06569823

SponsorDynavax Technologies Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Ouzama Henry, MD

(510) 848-5100 ohenry@dynavax.com

View on ClinicalTrials.gov More Shingles trials

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing to participate; informed consent provided for the study
✓. Male or female ≥ 50 years of age (Part 1: 50 through 69 years of age, inclusive; Part 2: ≥ 70 years of age
✓. In good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
✓. Able to comprehend and follow all required trial procedures and be available for all visits scheduled in the trial
✓. Seronegative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) as assessed during Screening
✓. 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.

Exclusion criteria

✕. History of HZ
✕. Previous vaccination against varicella (chicken pox) or HZ
✕. 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)
✕. Confirmed SARS-CoV-2/COVID-19 infection as assessed during Screening within 7 days of first trial injection.
✕. If female of childbearing potential, is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy or to breastfeed

What they're measuring

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

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

Timeframe: 28 days following each dose

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

Part 2: Vaccine response

Timeframe: 4 weeks after the second study injection

Part 2: Anti-gE IgG antibody concentration

Timeframe: 4 weeks after the second study injection