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

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

Immune Response to MVA-BN Vaccination for Mpox: Current Evidence and Future Directions. (PubMed, Vaccines (Basel)) - "In contrast, T cell responses appear more sustained and may support long-term immunity in the absence of persistent antibody titres. This narrative review synthesises current evidence on the immunogenicity and durability of MVA-BN vaccination, highlights challenges in assay interpretation, and outlines key research priorities, including the need to explore correlates of protection, booster strategies, and next-generation vaccine design."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Evolving Threats: Adaptive Mechanisms of Monkeypox Virus (MPXV) in the 2022 Global Outbreak and Their Implications for Vaccine Strategies. (PubMed, Viruses) - "At the same time, we systematically evaluate the cross-protective efficacy and limitations of existing vaccines (ACAM2000, JYNNEOS, and LC16), as well as recent advances in novel vaccine platforms, especially mRNA vaccines, in inducing superior immune responses...The core of this paper is to elucidate the dynamic game between viral evolution and prevention and control strategies (especially vaccines). The key to addressing the long-term epidemiological challenges of MPXV in the future lies in continuously strengthening global surveillance of viral evolution (early warning of highly transmissible/pathogenic variants), accelerating the development of next-generation vaccines based on new mechanisms and platforms (e.g., multivalent mRNAs), and resolving the vaccine accessibility gap through global collaboration to build an integrated defense system of "Surveillance, Research and Development, and Equitable Vaccination," through global collaboration to address the..."

Journal • Review • Infectious Disease

Prolonged Monkeypox Virus Infections, California, USA, May 2022-August 2024. (PubMed, Emerg Infect Dis) - "No prolonged infections occurred in persons who received 2 JYNNEOS vaccine doses. Groups disproportionately affected by prolonged mpox should be prioritized for mpox vaccine education and outreach."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety monitoring of Imvamune vaccine during the 2022 mpox outbreak in Canada. (PubMed, Can Commun Dis Rep) - "Monitoring of AEFI reports following immunization with Imvamune submitted to CAEFISS has not identified any new or unexpected safety concerns in the Canadian adult population. The Public Health Agency of Canada continues to monitor for potential vaccine safety signals."

Journal • Infectious Disease

Acute Posterior Multifocal Placoid Pigment Epitheliopathy-Like Panuveitis Following Mpox Vaccination. (PubMed, Ocul Immunol Inflamm) - "His symptoms and clinical signs improved with topical and systemic corticosteroid therapy with no recurrence off treatment over a 9-month follow-up. Clinicians should be aware of the possibility of APMPPE-like panuveitis as a rare ocular complication following the mpox vaccine."

Journal • Infectious Disease • Ocular Inflammation • Ophthalmology • Uveitis • Vasculitis

Potential of MRNA vaccines for mpox prevention: current evidence and future directions. (PubMed, Ann Med Surg (Lond)) - "At present, JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic), showing favorable safety, and ACAM2000, a live attenuated virus with a high risk of side effects, are two vaccines that are indicated for mpox immunization...This paper elucidates the potential of mRNA technology to address the unmet needs in mpox prevention. It also highlights the need for genomic surveillance, immunological insights, and innovative delivery systems."

Journal • Review • Infectious Disease • Novel Coronavirus Disease