Trial reportVaccine2019
A phase 1 study of the safety, reactogenicity, and immunogenicity of a Schistosoma mansoni vaccine with or without glucopyranosyl lipid A aqueous formulation (GLA-AF) in healthy adults from a non-endemic area.
Trial report in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed, 64 citations in OpenAlex.
- A randomized, controlled Phase 1b trial of the Sm-TSP-2 Vaccine for intestinal schistosomiasis in healthy Brazilian adults living in an endemic area.PLoS neglected tropical diseases · 2023Trial
- Zoonotic Parasite Nanovaccines: Progress, Challenges, and Future Perspectives.Integrative zoology · 2026Review
- Optimization and production of a GLP-grade recombinant Sm29 vaccine against schistosomiasis: From expression to preclinical assessment.PLoS neglected tropical diseases · 2026Article
- Tissue-specific and sex-biased glycoproteomic landscape of Schistosoma mansoni.Nature communications · 2026Article
- Licensed and investigational TLR4 agonists as vaccine adjuvants: structural basis, clinical progress, and future directions.Frontiers in immunology · 2026Review
- Comprehensive identification and co-expression analysis of long non-coding RNAs across eight timepoints of Schistosoma mansoni life cycleMemorias do Instituto Oswaldo Cruz · 2026Article
- mRNA vaccines encoding variant forms of Sm-TSP-2 confer protective immunity against Schistosoma mansoni.NPJ vaccines · 2025Article
- Safety and immunogenicity of the Sm-p80 GLA-SE schistosomiasis vaccine.NPJ vaccines · 2025Article
- In silico design of a multi-epitope pan vaccine targeting Schistosoma species.Genomics & informatics · 2025Article
- Schistosomiasis: cercarial finding and recognizing of human hosts as a prerequisite of invasion.Clinical microbiology reviews · 2025Review
- Therapeutic challenges of schistosomiasis: mechanisms of action and current limitations.Journal of parasitic diseases : official organ of the Indian Society for Parasitology · 2025Review
- Pre-clinical studies of Schistosoma mansoni vaccines: A scoping review.PLoS neglected tropical diseases · 2025Article
- From cercariae to chronic inflammation: understanding schistosome infection and host immune responses.Frontiers in immunology · 2025Review
- Review
- Applications of the Methylotrophic YeastJournal of fungi (Basel, Switzerland) · 2024Review
- A Journey in Science: Molecular vaccines for global child health in troubled times of anti-science.Molecular medicine (Cambridge, Mass.) · 2024Article
- Transmission-Blocking Vaccines against Schistosomiasis Japonica.International journal of molecular sciences · 2024Review
- Schistosoma mansoni vaccine candidates identified by unbiased phage display screening in self-cured rhesus macaques.NPJ vaccines · 2024Article
- Schistosomiasis.Advances in experimental medicine and biology · 2024Review
- Therapeutic and vaccinomic potential of moonlighting proteins for the discovery and design of drugs and vaccines against schistosomiasis.American journal of translational research · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundSchistosomiasis caused by Schistosoma mansoni (Sm) is a chronic, debilitating and potentially deadly neglected tropical disease. The licensure of a vaccine to prevent schistosomiasis would represent a major breakthrough in public health.
methodsThe safety and immunogenicity of a candidate Sm vaccine were assessed in this phase I, double-blind, dose-escalation trial. Seventy-two healthy Sm-naïve 18-50 year olds were randomized to receive 3 doses ∼ 8 weeks apart of saline placebo, or 10 µg, 30 µg, or 100 µg of recombinant Sm-Tetraspanin-2 vaccine formulated on aluminum hydroxide adjuvant (Sm-TSP-2/Al) with or without 5 µg of glucopyranosyl lipid A aqueous formulation (GLA-AF). Clinical and serologic responses were assessed for 1 year after dose 3.
resultsVaccines were safe and well-tolerated. The most common reactions were injection site tenderness and pain, and headache and fatigue. Tenderness and pain were more frequent in groups receiving vaccine with GLA-AF than placebo (p = 0.0036 and p = 0.0014, respectively). Injection site reactions among those given Sm-TSP-2/Al with GLA-AF lasted 1.22 and 1.33 days longer than those receiving Sm-TSP-2/Al without GLA-AF or placebo (p < 0.001 for both). Dose- and adjuvant-related increases in serum IgG against Sm-TSP-2 were observed. Peak IgG levels occurred 14 days after dose 3. Seroresponse frequencies were low among recipients of Sm-TSP-2/Al without GLA-AF, but higher among subjects receiving 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF. More seroresponses were observed among those given 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF compared to placebo (p = 0.023 and p < 0.001, respectively). Seroresponse frequencies were 0%, 30%, 50%, and 89%, respectively, among those given placebo, or 10 µg, 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF, suggesting a dose-response relationship for Sm-TSP-2/Al with GLA-AF (p = 0.0001).
conclusionsSm-TSP-2/Al with or without GLA-AF was safe and well tolerated in a Sm-naïve population. A vaccine like the one under development may represent our best hope to eliminating this neglected tropical disease.
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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.