We also collected data for the peak GMT values in test groups of all trials. This represents the highest GMT value recorded for the test groups for all serologies either at baseline, after dose 2, or after dose 3. These results would help us compare immune responses against CYD-TDV in different trials. This data can be seen in Table 4 and Figure 7 below.
Peak GMT values of
Dayan, et al( 2013)
Table 4: Peak GMT Values( 1 / dil) in Test Groups of all trials
HSS, et al( 2013)
Lanata, et al( 2012)
Sabchareon, et al( 2012)
Villar, et al( 2013)
Leo, et al( 2-11)( 2013)
Leo, et al( 12-17)( 2013) DENV 1 436 151 179 146.1 320 56.6 28.5
DENV 2 647 180 178 326 504 101 48.7 DENV 3 1031 196 190 405 594 136 71.4 DENV 4 432 114 184 159 305 104 79.2
1200
1000
Peak GMT Values
800
600
400
200
0 DENV 1 DENV 2 DENV 3 DENV 4
Dayan HSS Lanata Sabchareon Villar leo 1 Leo 2
Figure 7: Peak GMT Values( 1 / dil) in Test Groups of all trials 3.4.2. Study Outcome: Safety of Intervention
All of the studies collected data for unsolicited systemic reactions, solicited injection-site reactions, solicited systemic reactions, and severe adverse effects.
All studies observed any immediate AEs that occurred within 30 minutes of injections( except for Lanata, et al). 22 Solicited injection-site reactions include erythema, swelling, and pain, among others, and were observed for up to 7 days after the injections in all trials. Solicited systemic reactions are systemic reactions which are expected from the injections, and include fever, headache, malaise, myalgia, and myasthenia, and were observed for up to 14 days after injections. Unsolicited systemic reactions are any systemic reactions in response to the vaccine that are not expected, and were observed for up to 28 days after each injection in all trials. Severe Adverse Effects were any serious illnesses or reactions contracted during the course of the trial that needed hospitalization. This included symptomatic dengue disease. All of the trials graded solicited and unsolicited reactions from 1-3
The data for safety of the vaccine is presented semi-quantitatively in Table 5