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NCT06569823 (Z-1018 in Shingles): BVCT ex-ante prediction vs. reported outcome

On 3 May 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 21 Aug 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (non-superior to Shingrix).

Clinical Trial

NCTID
NCT06569823
Drug Name
Z-1018
Drug MoA
subunit vaccine comprising gE antigen with CpG 1018 adjuvant
Drug Modality
Vaccine
Drug Class
Best-In-Class
Therapeutic Area
Infections
Indication
Shingles
Human Patients
764
Sponsor
Dynavax Technologies
Phase
Phase 1 Phase 2

Prediction of , index 1996

Prospective Prediction
Prediction Index
1996
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in herpes zoster risk reduction moderately inferior to Shingrix)
Technical Prediction
FAILURE (statistically significant clinical benefit in immunogenicity superior to placebo yet non-superior to Shingrix)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
110 days in advance
Readout Data Interpretation
Z-1018 achieved a composite vaccine response rate of 89.7%; slightly inferior to Shingrix that achieved a composite vaccine response rate of 90.3% in the same trial
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (non-superior to Shingrix)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

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
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
764
Lead sponsor
Dynavax Technologies Corporation
Conditions
Shingles; Herpes Zoster; Vaccine-Preventable Diseases
Interventions
BIOLOGICAL: Z-1018; BIOLOGICAL: Shingrix
Design
Randomized · Parallel · Double
Primary purpose
Prevention
Start
2024-06-17
Primary completion
2027-11
Completion
2031-11
Primary outcomes
  • Part 1 and Part 2: Percentage of participants with solicited local and systemic post-injection reactions (PIRs) (Up to 7 days following each dose)
  • Part 1 and Part 2: Percentage of participants with Adverse events (AEs) (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) (Day 1 through 12 months after the last dose of study injection)
  • Part 2: Vaccine response (4 weeks after the second study injection)
  • Part 2: Anti-gE IgG antibody concentration (4 weeks after the second study injection)

NCT06569823 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials