Ervebo (recombinant vesicular stomatitis virus (VSV) expressing the envelope glycoprotein of Ebola Virus Zaire) / Lumos Pharma, National Institute of Allergy and Infectious Diseases, Merck (MSD) - LARVOL DELTA

Immunogenicity, safety and vaccine shedding of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine in HIV-Infected Adults and Adolescents; a randomized controlled Canadian Immunization Research Network (CIRN) trial (ASTMH 2025) - P2 | "Shedding in saliva and urine was less common and resolved by D28. In summary, a single dose of rVSV-ZEBOV-V is highly immunogenic in people living with HIV on ART with CD4 T cell ≥200 cells/mm3, with a well-tolerated safety profile."

Clinical • Late-breaking abstract • Ebola Virus Disease • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Pain • CD4

Combatting the increase in filovirus outbreaks: the importance of preparedness and partnership in responding to Uganda's 2025 Sudan virus outbreak (ASTMH 2025) - "The vaccine is based on the recombinant vesicular stomatitis virus (rVSV) viral vector platform, the same technology utilized in Merck's licensed ERVEBO® vaccine against EBOV (Ebola Zair)...This experience highlights a much-needed partnership model where investigational emerging infectious disease vaccine candidates are available for testing as part of and alongside an outbreak response. This response was achieved through collaboration and coordination of efforts between multiple stakeholders and global health organizations, efficient communication among partners, pre-approved protocols and contracts, the availability of the vaccine doses in-country and previously generated preclinical and clinical data."

Late-breaking abstract • Ebola Virus Disease • Hematological Disorders • Infectious Disease

EBO-PEP: EBOla Post-Exposure Prophylaxis (clinicaltrials.gov) - P3 | N=160 | Not yet recruiting | Sponsor: ANRS, Emerging Infectious Diseases | Trial completion date: Dec 2027 ➔ Aug 2028 | Initiation date: May 2025 ➔ Oct 2025

Trial completion date • Trial initiation date • Ebola Virus Disease • Infectious Disease

Ebola virus' hidden target: virus transmission to and infection of skin. (PubMed, J Virol) - "We observed similar viral trafficking and cell tropism in the skin of mice intraperitoneally infected with a low containment EBOV model virus, rVSV/EBOV GP, allowing more detailed mechanistic studies...Using a surrogate EBOV model, we demonstrate that systemic infection can occur following topical administration through abraded skin and requires phosphatidylserine receptor, AXL, for optimal infection of skin. These findings redefine the role of skin in EBOV pathogenesis, with implications for barrier-targeted interventions."

Journal • Dermatology • Ebola Virus Disease • Infectious Disease • Inflammation • AXL

Thermostable bivalent & trivalent filovirus vaccines from insect cells: potency demonstrated after 3 months and 2 years. (PubMed, Vaccine) - "ERVEBO®, the sole FDA-approved filovirus vaccine, requires ultra-cold storage...Potency was demonstrated after 3 months and 2 years using stability-indicating assays including vaccine immunogenicity in a mouse model. The lyophilized formulations remained stable and retained their potent immunogenicity for up to 2 years at both 25 °C and 40 °C, offering a promising solution for shelf-stable insect-cell derived protein vaccines suitable for easy storage and distribution even in low-resource settings."

Journal • Ebola Virus Disease • Infectious Disease

REVIVE (Response to the Ebola Virus Vaccine) (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Tulane University | Trial primary completion date: Jan 2026 ➔ May 2026

Trial primary completion date • Dental Disorders • Ebola Virus Disease • Infectious Disease • Stomatitis

Immunology of Ebola Vaccine (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Emory University | Trial completion date: Dec 2026 ➔ Aug 2026 | Trial primary completion date: Dec 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Dental Disorders • Ebola Virus Disease • Infectious Disease • Stomatitis

Long-term antibody responses to the Ebola virus and the vaccine vector after rVSV-ZEBOV vaccination in DRC. (PubMed, Vaccine) - "Complementing prior findings, our results thus suggest a persistently detectable but strain-specific and slowly declining antibody response to EBOV up to 4 years after vaccination. Our data supports the administration of booster doses after 1-2 years for optimal protection, highlights potential strain-restrictive vaccine-induced immunity, and may inform on correlates of long-term protection."

Journal • Ebola Virus Disease • Infectious Disease

Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure (clinicaltrials.gov) - P2 | N=99 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Enrolling by invitation ➔ Completed | N=200 ➔ 99 | Trial completion date: Dec 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dental Disorders • Ebola Virus Disease • Infectious Disease • Stomatitis

Nanoscale Mechanical and Morphological Characterization of Ebolavirus-like Particles: Implications for Therapeutic Development. (PubMed, Int J Mol Sci) - "This study comprehensively determines the accuracy of EBOV approximation with a variety of model virions and the uniformity of mechanical and structural traits across different model virion types and preparation methods. This provides important implications for developing therapeutic treatments against EBOV using these model virions."

Journal • Infectious Disease

Multiple cell types support productive infection and dynamic translocation of infectious Ebola virus to the surface of human skin. (SID 2025) - "These observations were recapitulated using a BSL2 model virus, rVSV/EBOV GP...Using our infection model, we have demonstrated a route of EBOV transmission through the skin, identified the responsible cell subsets, and shown its utility for antiviral testing. This work is significant because it shows that infectious virus can traverse the skin to the epidermal surface, potentially contributing to person-to-person transmission."

Ebola Virus Disease • Infectious Disease • AXL

Impact of most promising Ebola therapies on survival: a secondary analysis during the tenth outbreak in the Democratic Republic of Congo. (PubMed, Virol J) - "Prompt identification and treatment, along with enhanced supportive care (such as replenishing fluids and electrolytes and managing symptoms), significantly improve survival chances. Concurrently, administering vaccines and using mAb114, REGN-EB3, and, to some extent, Remdesivir further increase patient survival rates."

Journal • Retrospective data • Ebola Virus Disease • Infectious Disease

Pre-clinical evaluation of immunogenicity and protective efficacy of a pan-orthoebolavirus virus-like particle (VLP) vaccine (IMMUNOLOGY 2025) - "In a mouse model of Ebola virus disease (EVD), a single shot of this vaccine afforded 100% protection against a lethal dose of mouse-adapted EBOV, protection and lack of EVD signs and symptoms that were comparable to those after vaccination with the FDA-approved rVSV-ZEBOV vaccine. Strong pre-clinical data reported here pave the way for a detailed mechanistic study before advancing this promising pan-orthoebolavirus vaccine into clinical trials. The study was funded, in part, by the Intramural Research Program, NIAID, NIH.Keywords: Animals Non-Human Primate; Cells T Cells; Infections Viral; Molecules Antibodies Antigens/Peptides/Epitopes"

Preclinical • Ebola Virus Disease • Infectious Disease

PREPARE: Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupational Risk for Exposure (clinicaltrials.gov) - P3 | N=70 | Not yet recruiting | Sponsor: Universitätsklinikum Hamburg-Eppendorf | Trial completion date: Feb 2027 ➔ Jun 2028 | Trial primary completion date: Mar 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Ebola Virus Disease • Infectious Disease

rVSVΔG-ZEBOV-GP Vaccine Is Highly Immunogenic and Efficacious Across a Wide Dose Range in a Nonhuman Primate EBOV Challenge Model. (PubMed, Viruses) - "The recombinant vesicular stomatitis virus-Zaire Ebolavirus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP) was highly effective against Ebola virus disease in a ring vaccination trial conducted during the 2014-2016 outbreak in Guinea and is licensed by regulatory agencies including US FDA, EMA, and prequalified by WHO...A single vaccination conferred 98% protection from lethal intramuscular EBOV challenge across all dose groups. These results demonstrate that robust antibody titers are induced in NHPs across a wide range of rVSVΔG-ZEBOV-GP vaccine doses, correlating with high levels of protection against death from EBOV challenge."

Journal • Ebola Virus Disease • Infectious Disease

Neonatal Survival Following Spontaneous Maternal Recovery From Ebola Virus Disease in a Resource-Limited Setting in Western Democratic Republic of the Congo. (PubMed, Case Rep Infect Dis) - "She was vaccinated with rVSV-ZEBOV three days before symptom onset and her real-time polymerase chain of reaction (RT-PCR) results confirmed EVD and malarial infection two days after, but she refused hospitalization. She was treated at home with PO ASAQ, amoxicillin, paracetamol, albendazole, omeprazole, and papaverine...She received intravenous, artesunate, ceftriaxone, and papaverine...At our last follow-up, in June 2023 (2 years, 3 months after delivery), the mother and the baby were in good health. Neonatal survival following spontaneous maternal recovery from EVD in the first trimester of gestation is rare but possible, even in the context of limited clinical resources for treatment."

Journal • Ebola Virus Disease • Hematological Disorders • Infectious Disease • Obstetrics

REVIVE (Response to the Ebola Virus Vaccine) (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Tulane University | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Jul 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Dental Disorders • Ebola Virus Disease • Infectious Disease • Stomatitis

EBO-BOOST: Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC (clinicaltrials.gov) - P3 | N=624 | Recruiting | Sponsor: Institute of Tropical Medicine, Belgium | Not yet recruiting ➔ Recruiting | Trial primary completion date: Oct 2025 ➔ Oct 2026

Enrollment open • Trial primary completion date • Ebola Virus Disease • Infectious Disease

Maternal and fetal survival following Ebola, HIV and Malaria co-infection in the first trimester of gestation in resource-limited setting in Democratic Republic of Congo. (PubMed, BMC Pregnancy Childbirth) - "In case of Ebola, HIV and malaria co-infection, maternal and fetal survival remains possible even in the context of resources limited-setting. This case raises questions about the effects of the interactions of these co-infections and/or their antibodies, treatment during immune adaptation of the gravid organism."

Journal • Ebola Virus Disease • Human Immunodeficiency Virus • Infectious Disease • Malaria • CD4

EBO-PEP: EBOla Post-Exposure Prophylaxis (clinicaltrials.gov) - P3 | N=160 | Not yet recruiting | Sponsor: ANRS, Emerging Infectious Diseases

New P3 trial • Ebola Virus Disease • Infectious Disease

Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure (clinicaltrials.gov) - P2 | N=200 | Enrolling by invitation | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Enrolling by invitation | N=99 ➔ 200 | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Dental Disorders • Ebola Virus Disease • Infectious Disease • Stomatitis

Vaccination Strategies for Ebola in the Democratic Republic of Congo: The WHO-Ebola Modeling Collaboration. (PubMed, Int J Infect Dis) - "Despite some level of social instability, ring vaccination with the rVSV-ZEBOV vaccine was highly effective during the 2018-2020 Ebola outbreak in the Democratic Republic of Congo. As compared to alternative vaccination strategies, ring vaccination was estimated to be the most efficient."

Journal • Ebola Virus Disease • Infectious Disease

Ebola Outbreak Response in the DRC with rVSV-ZEBOV-GP Ring Vaccination. (PubMed, N Engl J Med) - "Nonrandomized evidence regarding standard EVD control measures plus ring vaccination in eastern DRC reinforces the earlier randomized evidence from Guinea of vaccine efficacy against EVD onset 10 or more days after vaccination."

Journal • Ebola Virus Disease • Immunology • Infectious Disease

Vector induced humoral responses after rVSVΔG-ZEBOV-GP immunization identify vaccinated individuals and correlate with Ebola virus glycoprotein antibodies. (PubMed, J Infect Dis) - P2 | "We report a reliable assay to measure vector-induced humoral responses after rVSV-ZEBOV vaccination and demonstrate the assay's utility to confirm vaccination status."

Journal • Ebola Virus Disease • Infectious Disease • Stomatitis

Preclinical immunogenicity and efficacy of a vesicular stomatitis virus-based Sudan virus vaccine and an update on its performance in a phase 1 clinical trial (ASTMH 2024) - "IAVI is developing a SUDV vaccine based on a recombinant replication-competent vesicular stomatitis virus (rVSV) as used to develop ERVEBO®, the licensed single-dose ZEBOV vaccine produced by Merck...There were no serious adverse events and most adverse events were transient, mild or moderate local reactions limited to local reactogenicity. All dose levels generated detectable humoral immune responses as measured by anti-GP IgG ELISA providing strong support for continued development of rVSV∆G-SUDV-GP for vaccinating people at risk for SUDV infection."

P1 data • Preclinical • Hematological Disorders • Infectious Disease