AMINO AMSA-Indonesia EAMSC 2017 | Page 41


 Study Purpose
This review aims to discuss whether or not the CYD-TDV is a viable preventive measure for Dengue through a systematic review. The objective of this systematic review is to assess the efficacy( in terms of immunogenicity) and safety( in terms of reactogenicity) of the newly developed CYD-TDV.
2. Research Methodology 2.1. Search Strategies
A comprehensive literature search was conducted in October 2016 using the databases PubMed, The Cochrane Library, Scopus, ProQuest, EBSCOhost, and ScienceDirect. The combinations of terms used for the search included“ T etravalent Dengue V accine”,“ CYD-TDV”,“ children”, and“ immunogenicity”. Where applicable and available, appropriate advance search techniques were applied to narrow the search.
2.2. Selection of Trials
Inclusion Criteria: Randomized, controlled clinical trial studies Subjects aged 2 to 18 years old Use of the 3-dose CYD-TDV regimen as an intervention Humoral immunogenicity and safety of CYD-TDV as outcomes Exclusion Criteria:
Studies involving subjects of all age groups( children and adults) in the same treatment group
Studies that do not measure baseline characteristics of patients 2.3. Data Extraction The following data was extracted from the studies:
1. Geometric Mean Titers of neutralizing antibodies against DENV 1, DENV 2, DENV 3, and DENV 4 at baseline and after each dose of CYD-TDV and Control( Immunogenicity as a measure of efficacy)
2. Adverse reactions and safety profile of CYD-TDV and Control injections
3. Study Design: Population characteristics( Age, Region, Sample size, Baseline Seropositivity *), Intervention, Control, and Outcome measurements.
* Baseline seropositivity refers to the percentage of the population that has antibody titers ≥ 10 1 / dil for any one of the four dengue serologies( measured using Plaque Reduction Neutralization Test)