JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic - LARVOL DELTA

Monkey pox (Mpox): pathogenesis, genetic shifts, vaccination strategies and clinical insights. (PubMed, Arch Microbiol) - "Third-generation vaccines such as MVA-BN/JYNNEOS, are showing good safety profiles, moderate to high efficacy in comparison to older vaccines like the ACAM2000, with other platforms being under clinical development. Knowledge of clade-specific viral evolution, immune resistance and vaccine efficacy is crucial to the optimization of vaccination response, the prioritization of susceptible population, and preparedness to future outbreaks of ortho poxvirus."

Journal • Preclinical • Review • Human Immunodeficiency Virus • Infectious Disease

Understanding Monkeypox Virus Evolution, Host-Pathogen Interactions, and Therapeutic Advances. (PubMed, Rev Med Virol) - "In addition, we discuss recent advancements in the development of prophylactic vaccine for Mpox, including ACAM2000, LC16m8, JYNNEOS (MVA), and others. Future research directions include exploiting the conserved Mpox antigens to develop safer and more broadly protective vaccines. There is also an urgent need for international collaborations in surveillance, rapid response systems and comprehensive OMICS studies for understanding the viral evolution and mutations, which will greatly aid vaccine design and therapeutic strategies to combat Mpox."

Journal • Review • Infectious Disease • Pain

A humoral dilemma: reassessing monkeypox virus neutralizing antibodies at more than two years from Mpox or MVA-BN vaccination. (PubMed, J Infect Dis) - "MPXV-specific NAbs waned at >2 years from previous infection or vaccination, often becoming undetectable. Higher NAb titers at six months (univariate) and prior smallpox vaccination (multivariate) were associated with NAb detection at >2 years, whilst previous Mpox was marginally associated."

Journal • Infectious Disease

Mpox: Exploring Epidemiology, Disease Outcomes, and Preventative Vaccination Among People with HIV During the Ongoing Outbreaks. (PubMed, Viruses) - "We aim to provide healthcare providers, community stakeholders, and researchers with a foundational understanding of mpox in PWH and the role of MVA-BN in mpox prevention among this group, while highlighting areas of uncertainty. These insights may be helpful in the planning of future research and to inform strategies for the prevention and management of mpox among PWH, particularly those with advanced or uncontrolled HIV."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Pain

Differentiating mpox infection and vaccination using a validated multiplex orthopoxvirus IgG serology assay. (PubMed, J Clin Microbiol) - "Intriguingly, we found that antibody level ratios between certain MPXV and VACV orthologs could distinguish prior mpox infection from vaccinia vaccination. Overall, these data highlight the use of multi-antigen panels in challenging scenarios for serological testing, such as the cross-reactivity presented by orthopoxviruses."

Journal • Infectious Disease

A Multisectoral Study of Mpox Epidemiology, Resistance Surveillance, and Policy Gaps: Toward a One Health Framework. (PubMed, Clin Rev Allergy Immunol) - "Next, we discussed different treatment alternatives for Mpox, such as Tecovirimat and JYNNEOS vaccination, diagnostic techniques including polymerase chain reaction (PCR), serological tests, and new point-of-care diagnostics based on clustered regularly interspaced short palindromic repeats (CRISPR). Then, we highlighted the public health challenges of Mpox, including misdiagnosis, healthcare disparities, and the impact on immunosuppressed populations, particularly HIV-positive individuals. Finally, this study discussed the socioeconomic implications of Mpox outbreaks, emphasizing the need for global collaboration, enhanced surveillance, and robust vaccination programs to minimize future outbreaks."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Pro-inflammatory cytokine profiles and neutralizing antibodies in JYNNEOS-vaccinated and mpox-diagnosed individuals. (PubMed, NPJ Vaccines) - "A significant increase in the levels of cytokines IL-6 and IL-8 was detected at D30 in naive-vaccinated individuals. These findings enhance our understanding of the immunogenicity and protective mechanisms induced by JYNNEOS vaccination and highlight a previously unreported pro-inflammatory response as part of the immune repertoire triggered post-vaccination."

Journal • Infectious Disease • Inflammation • CXCL8 • IL6

POX-MVA-045: Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections (clinicaltrials.gov) - P2 | N=460 | Active, not recruiting | Sponsor: Bavarian Nordic | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2025 ➔ May 2026

Enrollment closed • Trial primary completion date • Infectious Disease

Differentiating Mpox Infection and Vaccination Using a Validated Multiplex Orthopoxvirus IgG Serology Assay. (PubMed, medRxiv) - "Intriguingly, we found that antibody level ratios between certain MPXV and VACV orthologs could distinguish prior mpox infection from vaccinia vaccination. Overall, these data highlight the use of multi-antigen panels in challenging scenarios for serological testing such as the cross-reactivity presented by orthopoxviruses."

Journal • Infectious Disease

Disseminated Mpox Infection in a Vaccinated Kidney Transplant Recipient (KIDNEY WEEK 2025) - "He was on a belatacept-based immunosuppressive regimen and has received Jynneos approximately two years prior to symptom onset...Given the severity of his lesions, he was treated with IV tecovirimat, vaccinia immune globulin (VIVIg), brincidofovir and topical cidofovir...Additional studies are needed to assess the effectiveness of these vaccines in immunocompromised patients. Figure 1: Perioral lesions before treatment (A) and after treatment ~2 months later (B), abdomen (C), right hand (D), and back lesions with typical desquamation (E)"

Clinical • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Renal Disease • Transplantation

Long-term consequences of monkeypox virus infection or modified vaccinia virus Ankara vaccination in Belgium (MPX-COHORT and POQS-FU-PLUS): a 24-month prospective and retrospective cohort study. (PubMed, Lancet Infect Dis) - "Individuals previously infected with MPXV show strong and durable immunological memory lasting up to 2 years after infection, in contrast to the less robust and shorter-lived response observed after MVA-BN vaccination. These findings suggest that MPXV infection confers long-term protection against reinfection, whereas vaccine-induced immunity can wane over time and requires boosting. Further studies are needed to determine whether booster doses can enhance the durability of immunological memory in previously vaccinated individuals. Should booster vaccination prove beneficial, targeted revaccination campaigns will be necessary to maintain population-level protection."

Journal • Retrospective data • Infectious Disease

Re-emergence and clinical management of monkeypox: insights into viral biology, therapeutics, and vaccination. (PubMed, Mol Biol Rep) - "Antiviral therapies such as tecovirimat (TPOXX), cidofovir, and brincidofovir are under consideration, with tecovirimat showing the most clinical promise...Currently approved vaccines include ACAM2000, LC16 KMB, and JYNNEOS (MVA-BN), with JYNNEOS preferred due to its safety profile, especially for immunocompromised individuals and pregnant women. Preventive strategies, public education, and international surveillance are essential to mitigate further outbreaks. Understanding the biology, clinical behavior, and control measures of Mpox is critical for informing future responses and improving global preparedness."

Journal • Review • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

Mpox-specific cellular and humoral immunity in mpox survivors living with HIV. (PubMed, Cell Rep) - "These data demonstrate that PLWH generate functional cellular and humoral immunity to MPXV post-mpox. Despite their immunocompromised state, mpox survivors with HIV are expected to have some protection against future MPXV exposures."

Journal • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8 • IFNG • IL2 • TNFA

Emerging threats of monkeypox virus in 2024: current insights and future directions. (PubMed, Future Sci OA) - "The study synthesizes current evidence on the virus's evolving epidemiology, diagnostic advances such as CRISPR and PCR techniques, and progress in vaccine development, focusing on JYNNEOS and ACAM2000...Our findings underscore the importance of sustained genomic surveillance, integrative One Health strategies that unite human, animal, and environmental health data, and robust global collaboration. Addressing these gaps is vital for curbing monkeypox and preparing for future zoonotic threats."

Journal • Review • Infectious Disease

Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells (clinicaltrials.gov) - P2 | N=744 | Recruiting | Sponsor: Bavarian Nordic | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Comparison of ELISA with the Multiplex Fluorescent Microsphere Assay for Anti-Orthopoxvirus IgG detection (ASTMH 2025) - "We evaluated this multiplex assay by testing 494 samples collected from various regions of the world, including those from Clade I or Clade II MPXV-infected persons, and from individuals who received smallpox (Dryvax and ACAM2000) or mpox (JYNNEOS) vaccination, for the presence of immunoglobulin G (IgG) antibodies to 7 different antigens...We analyzed the IgG reactivity profiles to different antigens and found them to be unique for individuals and groups. This multiplex profiling offers significant benefits over current ELISA-based assays for serosurveillance and immunoprobing for vaccines and infections."

Late-breaking abstract • Infectious Disease

Presence and Persistence of Monkeypox Virus DNA in Anatomic Sites and Body Fluids (ASTMH 2025) - "Fifty-three percent had received at least one dose of JYNNEOS vaccine and 40% received treatment with tecovirimat...Patients with mpox may shed virus in oral and rectal mucosa, saliva, and urine, although skin lesions appear to be the most persistent site of viral shedding. Severe immunosuppression may lead to significantly prolonged viral shedding from multiple sites and body fluids, though the frequency with which this occurs is unknown."

Human Immunodeficiency Virus • Infectious Disease • CD4

Breakthrough mpox cases among different vaccination routes and under distinct HIV status (EACS 2025) - P | "Purpose : To reduce mpox disease and spread, vaccination with 2 subcutaneous (SC) doses of the 3rd-generation smallpox vaccine MVA-BN was recommended for at-risk groups...Most cases occurred in non-SC/SC regimens. Whether this reflects longer post-vaccination intervals or regimen-induced immune differences will be evaluated with ongoing immunogenicity results."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Smallpox Vaccine Reduces Mpox Disease Severity and Symptoms (EACS 2025) - "Purpose : Data on the impact of completing two doses of the modified vaccinia Ankara vaccine, Bavarian Nordic (MVA-BN) on Mpox disease severity remain limited, especially among people with HIV (PWH)...In settings of limited vaccine resources, unvaccinated risk groups should be prioritized. In the absence of severely immunocompromised cases, there were no differences between PWH and MSM without HIV."

Human Immunodeficiency Virus • Infectious Disease • CD4

Mpox-specific humoral and cellular immune responses up to two years from natural infection or MVA-BN vaccination (EACS 2025) - "Conclusions : The lower antibody titers in VAC-naïve compared to VAC-experienced and CONV two years after exposure support the administration of a MVA-BN booster dose in this group in order to enhance humoral response. A benefit of the booster shot could also be assumed in convalescent PWH, due to the more marked decline in immune response."

Infectious Disease • IFNG

Evaluating the Human Immune Response to the JYNNEOS Vaccine (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Pandemic Preparedness: Comparative Analysis of COVID-19, Mpox, Nipah, and Smallpox (ASA 2025) - "For analysis of smallpox vaccine complications, data were pooled using a random-effects model, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to assess risk differences between ACAM2000 and JYNNEOS... R0 AnalysisCOVID-19 demonstrated the highest R0 (mean 6.0), significantly higher than Nipah virus (RO mean: 0.45, p < 0.05). Mpox and Smallpox exhibited moderate R0 values; Smallpox RO 1.75 and MPOX RO 4.5, respectively. The variance in transmissibility highlights the urgent need for containment strategies tailored to each pathogen's characteristics."

Anesthesia • Infectious Disease • Measles • Novel Coronavirus Disease

Genomic variability and immunological aspects involved in response to MPXV infection. (PubMed, Front Pharmacol) - "Although smallpox vaccines like MVA-BN and ACAM2000 provide cross-protection against Mpox, the MVA-BN vaccine showed a more favourable safety profile, but variable effectiveness compared to replicating vaccines. Antiviral agents such as tecovirimat and cidofovir have been used off-label, but emerging resistance and limited clinical efficacy highlight an urgent need for MPXV-specific therapeutics...This review aims to provide a comprehensive overview of the molecular biology, clinical features, the current drugs used to treat Mpox infection and the vaccines used to prevent the infection. It also discussing the limitations of these therapeutic tools and the improvements needed to enhance their efficacy."

Journal • Review • Infectious Disease

Inhibition of monkeypox polymerase holoenzyme and methyltransferase using bioactive compounds of black tea: a computational approach. (PubMed, Sci Rep) - "MM-GBSA calculations revealed greater stability with the polymerase holoenzyme than methyltransferase. Further in vitro and in vivo studies are needed to confirm their inhibitory effects."

Journal • Infectious Disease

Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells (clinicaltrials.gov) - P2 | N=744 | Not yet recruiting | Sponsor: Bavarian Nordic

New P2 trial • Infectious Disease