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Ad26.ZEBOV-Batch #2
Ad26.ZEBOV-Batch #2 is a Viral vector vaccine Biologic drug developed by Crucell Holland BV. It is currently in Phase 3 development for Ebola virus disease prevention.
Ad26.ZEBOV is a replication-incompetent adenovirus serotype 26 vector expressing the Ebola virus glycoprotein that primes the immune system to recognize and respond to Ebola virus infection.
Ad26.ZEBOV-Batch #2 is an intervention being studied in a clinical trial for its safety, tolerability, and immunogenicity in healthy adult participants. The exact mechanism of Ad26.ZEBOV-Batch #2 is currently unknown.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ad26.ZEBOV-Batch #2 |
|---|---|
| Sponsor | Crucell Holland BV |
| Drug class | Viral vector vaccine |
| Target | Ebola virus glycoprotein (GP) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This vaccine uses a non-replicating adenoviral vector to deliver genetic instructions for producing the Ebola virus surface glycoprotein, triggering both cellular and humoral immune responses. The Ad26 vector is designed to be safe and immunogenic while avoiding integration into host DNA. It is typically administered as part of a heterologous prime-boost regimen with other Ebola vaccine candidates to enhance protective immunity.
Approved indications
- Ebola virus disease prevention
Common side effects
- Injection site pain or erythema
- Fatigue
- Myalgia
- Headache
- Fever
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ad26.ZEBOV-Batch #2 CI brief — competitive landscape report
- Ad26.ZEBOV-Batch #2 updates RSS · CI watch RSS
- Crucell Holland BV portfolio CI
Frequently asked questions about Ad26.ZEBOV-Batch #2
What is Ad26.ZEBOV-Batch #2?
How does Ad26.ZEBOV-Batch #2 work?
What is Ad26.ZEBOV-Batch #2 used for?
Who makes Ad26.ZEBOV-Batch #2?
What drug class is Ad26.ZEBOV-Batch #2 in?
What development phase is Ad26.ZEBOV-Batch #2 in?
What are the side effects of Ad26.ZEBOV-Batch #2?
What does Ad26.ZEBOV-Batch #2 target?
Related
- Drug class: All Viral vector vaccine drugs
- Target: All drugs targeting Ebola virus glycoprotein (GP)
- Manufacturer: Crucell Holland BV — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Ebola virus disease prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing