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Priority List of Adverse Events of Special Interest for
Ebola
Recommended Protocol-specified AESIs for Ebola vaccine clinical trials
V1.0, 02 June 2026
The SPEAC recommended protocol-specified AESIs for inclusion in Ebola vaccine clinical trials are listed in the table below. This list applies to vaccines targeting Ebola virus, Sudan virus, Taï Forest virus, and Bundibugyo virus.
This list aligns with the Ebola AESI list tailored for the three investigational vaccines, found in Zenodo.
The master AESI list below is provided for easy reference to associated SPEAC resources in the event these other AESIs are encountered during a study.
Tailored vaccine-specific lists can also be generated in the CVSI platform, in the AESI section of the Ebola toolkit, by filtering on the relevant vaccine platform and “all vaccines.”
| Vaccine Platform | Recommended protocol-specified AESIs |
|---|---|
| rVSV | Acute aseptic arthritis, Single organ cutaneous vasculitis (SOCV) |
| ChAdOx1 | Thrombosis with thrombocytopenia syndrome and Vaccine-associated immune thrombotic thrombocytopenia (TTS-VITT) |
| mRNA | Myocarditis, Pericarditis |
AESI: Myocarditis / Pericarditis
Specific to Marburg disease: 
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
Specific to Marburg disease:
*
Specific to Vaccine: Live-attenuated
Brighton Case Definition: See FDA Toxicity Grading Scales†
Brighton CD Companion Guide: See FDA Toxicity Grading Scales†
AESI: Pancreatitis
Specific to Marburg disease:
*
Specific to Vaccine: Live-attenuated
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
Specific to Marburg disease: ✅*, §
Specific to Vaccine: Live-attenuated
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
Specific to Marburg disease:
Brighton Case Definition: NO**
Brighton CD Companion Guide: NO**
AESI: Vaccine-associated Immune Thrombotic Thrombocytopenia (VITT)
Specific to vaccine: Ad-vectored
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Thrombocytopenia
Specific to Marburg disease:
Specific to vaccine: All
Brighton Case Definition: Click to access Brighton CD Companion Guide: Click to access
AESI: Venous thromboembolism (VTE)
Specific to Marburg disease:
*
Specific to vaccine: Live-attenuated vaccines
Brighton Case Definition: TBD
Brighton CD Companion Guide: TBD
AESI: Anaphylaxis
Specific to vaccine: All vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Acute aseptic arthritis
Specific to vaccine: VSV-vectored
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Severe MARV infection (ARDS; AKI with KDIGO ≥2; NEWS2≥7; LFTs≥3X upper limit of normal; shock; multisystem organ failure; death)†† or enhanced disease§§
Specific to Marburg disease: *,††
Specific to vaccine: All vaccines §§
Brighton Case Definition: NO
Brighton CD Companion Guide: NO
Specific to Marburg disease:
*
Specific to vaccine: Live-attenuated
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Acute Encephalitis
Specific to Marburg disease:
*
Specific to vaccine: Live-attenuated
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Myelitis
Specific to Marburg disease:
Specific to vaccine: All vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: ADEM
Specific to vaccine: Ad-vectored
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Generalized convulsion
Specific to Marburg disease:
Specific to vaccine: All vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Guillain Barré Syndrome
Specific to vaccine: Some vaccines
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
Specific to Marburg disease:
*, §, ¶¶
Specific to vaccine: Live-attenuated
Brighton Case Definition: NO
Brighton CD Companion Guide: NO
Specific to Marburg disease:
*
Specific to vaccine: Live-attenuated
Brighton Case Definition: NO
Brighton CD Companion Guide: NO
Specific to Marburg disease:
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
Specific to Marburg disease:
*
Specific to vaccine: Live-attenuated
Brighton Case Definition: Click to access
Brighton CD Companion Guide: NO
AESI: Single organ cutaneous vasculitis
Specific to vaccine: VSV-vectored
Brighton Case Definition: Click to access
Brighton CD Companion Guide: pending
AESI: Stillbirth
Specific to Marburg disease:
Specific to vaccine: Any vaccine
Brighton Case Definition: Click to access †††
Brighton CD Companion Guide: YES
AESI: Spontaneous abortion / Miscarriage
Specific to Marburg disease:
Specific to vaccine: Any vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Antenatal hemorrhage
Specific to Marburg disease:
Specific to vaccine: Any vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: NO
AESI: Preeclampsia / Eclampsia
Specific to vaccine: Any vaccine
Brighton Case Definition: Click to access §§§
Brighton CD Companion Guide: NO
AESI: Congenital anomalies
Specific to Marburg disease:
Specific to vaccine: Any vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: NO
AESI: Preterm birth
Specific to Marburg disease:
Specific to vaccine: Any vaccine
Brighton Case Definition: Click to access
Brighton CD Companion Guide: Click to access
AESI: Febrile seizure¶¶¶
Specific to Marburg disease:
Specific to vaccine: Any vaccine
Brighton Case Definition: NO****
Brighton CD Companion Guide: NO****
Priority List of Adverse events of special interest for
Mpox
ebola AESI List
Version 1.4 (Updated 18 June 2026)
This list of potential Adverse Events of Special Interest (AESI) that could follow vaccines to prevent Ebola was developed based on criteria established by the Safety Platform for Emergency Vaccines (SPEAC), which include:
- A known association with immunization or a specific vaccine platform.
- The occurrence during wild-type disease due to viral replication and/or immunopathogenesis.
- A theoretical association derived from animal models.
Special populations, including pregnant women, children, adolescents, and immunosuppressed individuals, may experience an increased frequency and severity of any of the AESIs listed as relevant to all populations. There are also specific AESI that are of particular relevance to special populations, and these are listed according to the population. It is important to note that children, pregnant women and immunocompromised individuals may also have increased severity of expected local and systemic reactogenicity, as well as unexpected autoimmune conditions.
The SPEAC Executive Board welcomes input on this AESI list and will update it periodically. Please share input with the SPEAC and Brighton Collaboration team at bc-coordinator@taskforce.org.
This list is based on available data for Ebola vaccines, for consideration in deployment of investigational vaccines in response to the 2026 epidemic of Bundibugyo virus disease (BVD) in the Democratic Republic of Congo and Uganda. Adaptions may be needed depending on the application.
Note: This AESI list is meant to be a reference; if certain AESIs on the list will be captured in routine safety surveillance in a study, those AESIs may not need to be protocol-specified. Only a subset of the AESI list will typically need to be included as protocol-specified AESIs: those that would require a systematic approach to data collection to characterize; or that may not be captured in routine safety surveillance.
View the list below, and download it from our Zenodo site.
