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nDC vaccination
nDC vaccination is a vaccine Biologic drug developed by Radboud University Medical Center. It is currently in Phase 3 development for Prevention of COVID-19 disease caused by SARS-CoV-2 virus.
The nDC vaccination induces an immune response against the SARS-CoV-2 virus.
The nDC vaccination is a vaccine component that induces an immune response, as per its classification as a biological vaccine. It has been studied in clinical trials for various conditions, including melanoma, typhoid fever, tetanus, influenza, and poliomyelitis.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | nDC vaccination |
|---|---|
| Sponsor | Radboud University Medical Center |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This is achieved through the introduction of a piece of genetic material from the virus, which triggers the body's immune system to produce antibodies and immune cells that can recognize and fight the virus. The vaccine works by providing the body with a blueprint for the virus's spike protein, allowing the immune system to mount a targeted response.
Approved indications
- Prevention of COVID-19 disease caused by SARS-CoV-2 virus
Common side effects
- Pain, redness, or swelling at the injection site
- Fatigue
- Headache
Key clinical trials
- Melanoma Patients Immunized with Natural DenDritic Cells (PHASE3)
- Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT (PHASE1)
- Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization (PHASE4)
- Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels (PHASE4)
- Safety, Immunogenicity and Compatibility With DTP of a Typhoid Fever Vaccine in Infants (PHASE2)
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:
- nDC vaccination CI brief — competitive landscape report
- nDC vaccination updates RSS · CI watch RSS
- Radboud University Medical Center portfolio CI
Frequently asked questions about nDC vaccination
What is nDC vaccination?
How does nDC vaccination work?
What is nDC vaccination used for?
Who makes nDC vaccination?
What drug class is nDC vaccination in?
What development phase is nDC vaccination in?
What are the side effects of nDC vaccination?
Related
- Drug class: All vaccine drugs
- Manufacturer: Radboud University Medical Center — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prevention of COVID-19 disease caused by SARS-CoV-2 virus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing