Trial reportClinical and vaccine immunology : CVI2014
Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults.
Trial report in Clinical and vaccine immunology : CVI, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00756067 (A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines), which is not on this map. Cited by 15 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.
A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Immunosenescence: A systems-level overview of immune cell biology and strategies for improving vaccine responses.Experimental gerontology · 2019Pooled it
- Reactogenicity, safety and immunogenicity of a protein-based pneumococcal vaccine in Gambian children aged 2-4 years: A phase II randomized study.Human vaccines & immunotherapeutics · 2016Trial
- Review
- Distinct effects of adjuvants on B cell responses to protein or polysaccharide antigens contained in glycoconjugate vaccines.Frontiers in immunology · 2025Article
- Peptide vaccines: an innovative therapeutic approach against antibiotic-resistant bacterial infections.Frontiers in immunology · 2025Review
- Semisynthetic Pneumococcal Glycoconjugate Nanovaccine.Bioconjugate chemistry · 2023Article
- Precision Vaccine Adjuvants for Older Adults: A Scoping Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Article
- Review
- Review
- Vaccines to Prevent Infectious Diseases in the Older Population: Immunological Challenges and Future Perspectives.Frontiers in immunology · 2020Review
- Immunogenicity And Safety Of The 13-Valent Pneumococcal Conjugate Vaccine In Patients With Monoclonal Gammopathy Of Undetermined Significance - Relationship With Selected Immune And Clinical Parameters.Clinical interventions in aging · 2019Article
- Pneumococcal whole-cell and protein-based vaccines: changing the paradigm.Expert review of vaccines · 2017Review
- A Combination of Recombinant Mycobacterium bovis BCG Strains Expressing Pneumococcal Proteins Induces Cellular and Humoral Immune Responses and Protects against Pneumococcal Colonization and Sepsis.Clinical and vaccine immunology : CVI · 2017Article
- The First Histidine Triad Motif of PhtD Is Critical for Zinc Homeostasis in Streptococcus pneumoniae.Infection and immunity · 2016Article
- Human antibodies to PhtD, PcpA, and Ply reduce adherence to human lung epithelial cells and murine nasopharyngeal colonization by Streptococcus pneumoniae.Infection and immunity · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Six vaccine formulations containing AS02V or alum (aluminum phosphate [AlPO4]) adjuvant with pneumococcal proteins, pneumococcal histidine triad D (PhtD), and/or detoxified pneumolysin (dPly), either as a polysaccharide carrier in an 8-valent pneumococcal conjugate vaccine (8PCV) or as free (unconjugated) proteins, were evaluated in adults -65 to 85 years of age. In this phase I observer-blind study, 167 healthy subjects were randomized to receive two doses (days 0 and 60) of 10 or 30 μg PhtD-dPly plus AS02V or alum, 8PCV plus AS02V or alum, or one dose (day 0) of 23-valent polysaccharide pneumococcal vaccine (23PPV) as a control (placebo on day 60). The safety, reactogenicity, and antibody-specific responses to these vaccines were evaluated. No vaccine-related serious adverse events were reported. The incidences of solicited local and specific general (fatigue and myalgia) symptoms tended to be higher in the AS02V groups than in other groups. Anti-PhtD and anti-Ply antibody responses were observed in all groups except the control group. One month post-dose 2, the anti-PhtD and anti-Ply antibody geometric mean concentrations tended to be higher with AS02V than with alum, higher with a dose of 30 μg than with 10 μg for PhtD-dPly and higher with 30-μg PhtD-dPly formulations than with conjugated PhtD and dPly (8PCV) formulations. Functional antibody responses, measured by an opsonophagocytic activity assay, tended to be higher with 8PCV than with 23PPV. In conclusion, vaccine formulations containing free or conjugated PhtD and dPly had acceptable reactogenicity and safety profiles in elderly adults. Immune responses were enhanced with an AS02V-adjuvanted formulation containing free 30-μg PhtD-dPly compared to those with alum adjuvant and conjugated proteins. (This study has been registered at ClinicalTrials.gov under registration no. NCT00756067.).
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