From the *Centro de Investigaciones Epidemiológicas, Universidad Industrial de Santander, Bucaramanga, Colombia; †Organización para el Desarrollo y la Investigación Salud en Honduras, Tegucigalpa, Honduras; ‡Instituto Nacional de Pediatría, Unidad de Apoyo a la Investigación Clínica, Mexico City, Mexico; §Sanofi Pasteur, Swiftwater, PA; ¶Sanofi Pasteur, Montevideo, Uruguay; ‖Sanofi Pasteur, Bogota, Colombia; and **Sanofi Pasteur, Mexico City, Mexico.
Pediatr Infect Dis J. 2013 Oct;32(10):1102-9. doi: 10.1097/INF.0b013e31829b8022.
The dengue virus is a member of the Flavivirus (FV) genus, which also includes the yellow fever virus. Dengue disease is caused by any 1 of 4 dengue virus serotypes and is a serious public health concern in Latin America. This study evaluated the safety and immunogenicity of a candidate recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in 9-16 year olds in Latin America.
In this randomized, blinded, controlled study, volunteers received either 3 doses of CYD-TDV (n = 401) or placebo as first and second injection and tetanus/diphtheria/acellular pertussis vaccine as third injection (n = 199) at 0, 6 and 12 months. Adverse events were documented. Plaque reduction neutralization test antibody titers against the 4 CYD-TDV parental strains were measured before and 28 days after each dose. Seropositivity was defined as antibody titers ≥10 1/dil.
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.
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.
登革病毒属于黄病毒（FV）属，该属还包括黄热病病毒。登革热是由 4 种登革病毒血清型中的任何 1 种引起的，是拉丁美洲严重的公共卫生关切。本研究评估了候选重组、减毒、四价登革热疫苗（CYD-TDV）在拉丁美洲 9-16 岁儿童中的安全性和免疫原性。
在这项随机、双盲、对照研究中，志愿者在 0、6 和 12 个月时分别接受 3 剂 CYD-TDV（n=401）或安慰剂作为第一和第二剂，以及破伤风、白喉和无细胞百日咳疫苗作为第三剂（n=199）。记录不良反应。在每次剂量前和后 28 天测量针对 4 种 CYD-TDV 亲代株的血清中和抗体滴度。将抗体滴度≥10 1/dil 定义为血清阳性。
每次连续接种 CYD-TDV 后，不良反应的数量减少。在每次 CYD-TDV 剂量后，针对所有 4 种血清型的抗体滴度均高于基线和各自的预剂量滴度。在接受第三剂 CYD-TDV 后，100%、98.6%和 93.4%的参与者对至少 2 种、至少 3 种或所有 4 种血清型的血清阳性率分别为 100%、98.6%和 93.4%。在基线时 FV 血清阳性的参与者中，观察到更高的抗体滴度与 FV 血清阴性者相比。
CYD-TDV 在拉丁美洲 9-16 岁儿童中具有良好的安全性，并针对所有 4 种登革热病毒血清型引起了抗体反应。这些发现支持继续开发 CYD-TDV。
