The antibody levels against each serotype will be measured before and after each vaccination.
The subjects will be followed for 28 days after each vaccination for solicited and unsolicited safety parameters. Serious adverse events (SAEs) will be collected throughout the Phase 2 study.
The results of this Phase 2 clinical trial were published by Pediatric Infectious Diseases Journal.
Results: The number of adverse reactions decreased after each successive CYD-TDV dose. After each CYD-TDV dose, antibody titers against all 4 serotypes were higher than baseline and respective predose titers. After the third dose of CYD-TDV, 100%, 98.6% and 93.4% of participants were seropositive for at least 2, at least 3 or all 4 serotypes, respectively. Higher antibody titers were observed in participants in the CYD-TDV group who were FV-seropositive at baseline compared with those who were FV-seronegative.
Conclusions: CYD-TDV had a favorable safety profile and elicited antibody responses against all 4 dengue virus serotypes in 9-16-year-olds in Latin America. These findings support the continued development of CYD-TDV.