Overview
Sponsor-declared trial summary
The clinical trial itself does not investigate a medical condition or disease. Rather, the safety and immunogenicity of a vaccine against SARS-CoV-2 infection is being investigated.
Key facts
- Sponsor
- Universitaetsklinikum Tuebingen AöR
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 26 Mar 2026 → ongoing
- Decision date (initial)
- 2024-03-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511266-36-00
- EudraCT number
- 2021-001191-42
- WHO UTN
- U1111-1303-8564
- ClinicalTrials.gov
- NCT05389319
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
The clinical trial itself does not investigate a medical condition or disease. Rather, the safety and immunogenicity of a vaccine against SARS-CoV-2 infection is being investigated.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10085559 | Revaccination with different COVID-19 vaccine | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Tuebingen AöR
- Sponsor organisation
- Universitaetsklinikum Tuebingen AöR
- Address
- Geissweg 3, Innenstadt Innenstadt
- City
- Tübingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Sponsor Clinical Trial Contact
Public contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Sponsor Clinical Trial Contact
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 96 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2022-06-24 | 2022-06-24 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-18566
- Halt date
- 2023-07-04
- Planned restart
- 2024-08-01
- Member states concerned
- Germany
- Publication date
- 2024-03-26
- Reason
- Sponsor decision, Medicinal Product related
- Explanation
- The clinical trial was temporarily halted due to the finding that the titer of a released investigational product batch had decreased within three months to only 67.5 % of its original titer value.
- Follow-up measures
- At the time of implementation of the temporary halt, no subjects were actively participating in the clinical trial. Hence, no follow-up measures were initiated on the subjects’ level.
Based on current toxicity and stability data, the Sponsor is considering making an adjustment to the next dose. It is planned to administer a new batch of the investigational product with a higher dose instead. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-11 | Germany | Acceptable 2024-03-22
|
2024-03-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-16 | Germany | Acceptable 2025-06-06
|
2025-06-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-08 | Germany | Acceptable 2025-12-12
|
2025-12-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-16 | Germany | Acceptable 2026-02-16
|
2026-02-23 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-30 | Germany | Acceptable 2026-02-16
|
2026-03-30 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-13 | Germany | Acceptable 2026-02-16
|
2026-04-13 |