How to evaluate potential non-specific effects of vaccines: the quest for randomized trials or time for triangulation?
| Autor: | Christine Stabell Benn, Ane Bærent Fisker, Andreas Rieckmann, Peter Aaby, Aksel Karl Georg Jensen |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Poliovirus Vaccine Oral/administration & dosage Immunology Measles Vaccine triangulation Immunity Heterologous child mortality law.invention 03 medical and health sciences 0302 clinical medicine Non specific Randomized controlled trial Randomized Controlled Trials as Topic/methods Bias law Drug Discovery medicine Humans Medical physics 030212 general & internal medicine Vaccination/methods observational studies Randomized Controlled Trials as Topic Pharmacology child morbidity Vaccines evaluation Vaccination Triangulation (social science) Vaccines/administration & dosage vaccine policy 030104 developmental biology Research Design Poliovirus Vaccine Oral non-specific effects randomized controlled trials Molecular Medicine Immunity Heterologous/immunology Observational study Measles Vaccine/administration & dosage Psychology |
| Zdroj: | Benn, C S, Fisker, A B, Rieckmann, A, Jensen, A K G & Aaby, P 2018, ' How to evaluate potential non-specific effects of vaccines : the quest for randomized trials or time for triangulation? ', Expert Review of Vaccines, vol. 17, no. 5, pp. 411-420 . https://doi.org/10.1080/14760584.2018.1471987 |
| ISSN: | 1744-8395 |
| DOI: | 10.1080/14760584.2018.1471987 |
| Popis: | Introduction: Emerging evidence suggests that vaccines, in addition to their disease-specific effects, have important non-specific effects (NSEs), which contribute to their overall effect on mortality and morbidity. Immunological studies have shown that NSEs are biologically plausible. Many advocate that randomized controlled trials (RCTs) with overall mortality or morbidity as the outcome are the only way forward to confirm or refute NSEs. Areas covered: We discuss the limitations of using RCTs only as a tool to evaluate NSEs of vaccines. Such RCTs can be ethically problematic, they are time consuming and expensive. Furthermore, they only assess the NSEs in a given context, but it is inherent in the concept of NSEs that the NSEs of a given vaccine are modified by other immunomodulatory conditions. As an alternative, we propose that triangulation of RCTs and observational studies, merging multiple lines of evidence with different underlying bias structures, can build a strong argument for causality. We examine two examples related to measles vaccine and oral polio vaccine. Expert commentary: Using RCTs alone to evaluate NSEs of vaccines severely limits the possibilities for studying NSEs. Results from both RCTs and non-RCT studies should be triangulated to strengthen causal interpretation. |
| Databáze: | OpenAIRE |
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