SynthesisPloS one2016
Meta-Analysis on Randomized Controlled Trials of Vaccines with QS-21 or ISCOMATRIX Adjuvant: Safety and Tolerability.
Synthesis in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
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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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Controlling timing and location in vaccines.Advanced drug delivery reviews · 2020Pooled it
- Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naïve adults.Human vaccines & immunotherapeutics · 2019Trial
- Toxicological evaluation of a synthetic QS-21 adjuvant in a tuberculosis vaccine candidate-Demonstrating safety and immunological equivalence to natural reference.Human vaccines & immunotherapeutics · 2026Article
- Advances in the heterologous biosynthesis of QS saponins: a review.Microbial cell factories · 2026Review
- Design and mechanistic insights into ZMF59/CpG: a complementary adjuvant system boosting immunity and safety in herpes zoster vaccines.Journal of nanobiotechnology · 2026Article
- Leaf Saponins ofPharmaceutics · 2025Review
- Active Immunization Targeting Amyloid β for the Treatment of Alzheimer's Disease.Neuro-degenerative diseases · 2025Review
- Enhancement of the immunogenicity of aIranian journal of basic medical sciences · 2024Article
- Novel adjuvants in allergen-specific immunotherapy: where do we stand?Frontiers in immunology · 2024Review
- Potentials of saponins-based adjuvants for nasal vaccines.Frontiers in immunology · 2023Review
- Article
- The Immune System as a Therapeutic Target for Alzheimer's Disease.Life (Basel, Switzerland) · 2022Review
- ISCOM-like Nanoparticles Formulated withVaccines · 2021Article
- Interplay of diverse adjuvants and nanoparticle presentation of native-like HIV-1 envelope trimers.NPJ vaccines · 2021Article
- Performance of a Four-AntigenMicroorganisms · 2021Article
- Targeting Neoepitopes to Treat Solid Malignancies: Immunosurgery.Frontiers in immunology · 2021Review
- Nano and Microparticles as Potential Oral Vaccine Carriers and Adjuvants Against Infectious Diseases.Frontiers in pharmacology · 2021Review
- Review
- Review
- The Delay in the Licensing of Protozoal Vaccines: A Comparative History.Frontiers in immunology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesQS-21 shows in vitro hemolytic effect and causes side effects in vivo. New saponin adjuvant formulations with better toxicity profiles are needed. This study aims to evaluate the safety and tolerability of QS-21 and the improved saponin adjuvants (ISCOM, ISCOMATRIX and Matrix-M™) from vaccine trials.
methodsA systematic literature search was conducted from MEDLINE, EMBASE, Cochrane library and Clinicaltrials.gov. We selected for the meta-analysis randomized controlled trials (RCTs) of vaccines adjuvanted with QS-21, ISCOM, ISCOMATRIX or Matrix-M™, which included a placebo control group and reported safety outcomes. Pooled risk ratios (RRs) and their 95% confidence intervals (CIs) were calculated using a random-effects model. Jadad scale was used to assess the study quality.
resultsNine RCTs were eligible for the meta-analysis: six trials on QS-21-adjuvanted vaccines and three trials on ISCOMATRIX-adjuvanted, with 907 patients in total. There were no studies on ISCOM or Matrix-M™ adjuvanted vaccines matching the inclusion criteria. Meta-analysis identified an increased risk for diarrhea in patients receiving QS21-adjuvanted vaccines (RR 2.55, 95% CI 1.04-6.24). No increase in the incidence of the reported systemic AEs was observed for ISCOMATRIX-adjuvanted vaccines. QS-21- and ISCOMATRIX-adjuvanted vaccines caused a significantly higher incidence of injection site pain (RR 4.11, 95% CI 1.10-15.35 and RR 2.55, 95% CI 1.41-4.59, respectively). ISCOMATRIX-adjuvanted vaccines also increased the incidence of injection site swelling (RR 3.43, 95% CI 1.08-10.97).
conclusionsOur findings suggest that vaccines adjuvanted with either QS-21 or ISCOMATRIX posed no specific safety concern. Furthermore, our results indicate that the use of ISCOMATRIX enables a better systemic tolerability profile when compared to the use of QS-21. However, no better local tolerance was observed for ISCOMATRIX-adjuvanted vaccines in immunized non-healthy subjects. This meta-analysis is limited by the relatively small number of individuals recruited in the included trials, especially in the control groups.
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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.