Trial reportThe Journal of infectious diseases2011
Safety and immunogenicity of LC16m8, an attenuated smallpox vaccine in vaccinia-naive adults.
Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 61 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LC16m8, A Modified Vaccinia Vaccine, in Healthy Volunteers
Randomized Trial to Evaluate the Efficacy/Effectiveness, Safety, and Immunogenicity of Replicative Live Attenuated Vaccinia Virus Vaccine LC16m8 for Prevention Against Mpox in High-risk Populations During Vaccination Deployment in Colombia
Who cites it
61 citing papers in PubMed, 2 syntheses or guidelines pooled it, 105 citations in OpenAlex.
- Maternal and Pediatric Use of Vaccines for Mpox: A Living Systematic Review and Meta-analysis of Safety and Effectiveness.Drug safety · 2026Pooled it
- Global perspectives on smallpox vaccine against monkeypox: a comprehensive meta-analysis and systematic review of effectiveness, protection, safety and cross-immunogenicity.Emerging microbes & infections · 2024Pooled it
- An open-label, non-randomized study investigating the safety and efficacy of smallpox vaccine, LC16, as post-exposure prophylaxis for mpox.Human vaccines & immunotherapeutics · 2023Trial
- A comprehensive overview of monkeypox virus disease.Tropical medicine and health · 2026Review
- Exploration of the protein and pharmacological landscape of monkeypox virus treatment: from entry point to end point.Molecular diversity · 2026Review
- Emerging Viral Zoonoses: Epidemiology, Vaccination Strategies, and Implications for Global Public Health.Vaccines · 2026Review
- Monkeypox (Mpox), a Resurging Global Public Health Concern: An Updated Outlook Through 2025.Current issues in molecular biology · 2026Review
- Monkey pox (Mpox): pathogenesis, genetic shifts, vaccination strategies and clinical insights.Archives of microbiology · 2026Review
- Philippine Clinical Practice Guidelines for Periodic Health Examination: Immunization for Adults.Acta medica Philippina · 2026Article
- Review
- Tiantan vaccinia virus-based vaccine with promising safety provides sustained protection against mpox in non-human primates.Nature communications · 2025Article
- Safety and Efficacy of Repurposed Smallpox Vaccines Against Mpox: A Critical Review of ACAM2000, JYNNEOS, and LC16.Journal of epidemiology and global health · 2025Review
- Comparison of the induction of neutralizing antibodies against Bas congo virus using several vaccine modalities.Scientific reports · 2025Article
- Monoclonal Antibodies in Light of Mpox Outbreak: Current Research, Therapeutic Targets, and Animal Models.Antibodies (Basel, Switzerland) · 2025Review
- Article
- Current advances and challenges in mpox vaccine development: a global landscape.Therapeutic advances in vaccines and immunotherapy · 2025Review
- Article
- 2024 Mpox outbreak: A rapidly evolving public health emergency of international concern: Introduction of an Updated Mpox Identify-Isolate-Inform (3I) Tool.One health (Amsterdam, Netherlands) · 2024Article
- Review
- Recent research advances in the development of Dabie Banda virus vaccines.PLoS neglected tropical diseases · 2024Review
1 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
15 authors at 10 institutions in 2 countries.
Funding
Abstract
introductionLC16m8 is an attenuated cell culture-adapted Lister vaccinia smallpox vaccine missing the B5R protein and licensed for use in Japan.
methodsWe conducted a phase I/II clinical trial that compared the safety and immunogenicity of LC16m8 with Dryvax in vaccinia-naive participants. Adverse events were assessed, as were electrocardiography and laboratory testing for cardiotoxicity and viral culturing of the vaccination sites. Neutralization titers to vaccinia, monkeypox, and variola major were assessed and cell-mediated immune responses were measured by interferon (IFN)-γ enzyme-linked immunosorbent spot and lymphoproliferation assays.
resultsLocal and systemic reactions after vaccination with LC16m8 were similar to those reported after Dryvax. No clinically significant abnormalities consistent with cardiac toxicity were seen for either vaccine. Both vaccines achieved antivaccinia, antivariola, and antimonkeypox neutralizing antibody titers >1:40, although the mean plaque reduction neutralization titer of LC16m8 at day 30 after vaccination was significantly lower than Dryvax for anti-NYCBH vaccinia (P < .01), antimonkeypox (P < .001), and antivariola (P < .001). LC16m8 produced robust cellular immune responses that trended higher than Dryvax for lymphoproliferation (P = .06), but lower for IFN-γ ELISPOT (P = .02).
conclusionsLC16m8 generates neutralizing antibody titers to multiple poxviruses, including vaccinia, monkeypox, and variola major, and broad T-cell responses, indicating that LC16m8 may have efficacy in protecting individuals from smallpox. Clinical Trials Registration. NCT00103584.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.