International Vaccine Institute, Seoul, Republic of Korea.
Kanti Children's Hospital, Kathmandu, Nepal.
Vaccine. 2022 Sep 22;40(40):5828-5834. doi: 10.1016/j.vaccine.2022.08.034. Epub 2022 Sep 3.
Typhoid fever is a common disease in developing countries especially in the Indian subcontinent and Africa. The available typhoid conjugate vaccines (TCV) have been found to be highly immunogenic in infants and children less than 2 years of age. Many countries are planning to adopt TCV in their routine EPI programs around 9 months of age when measles containing vaccines are given. Therefore, Vi-DT TCV was tested in 9-15 months aged healthy infants in Nepal to demonstrate non-interference with a measles containing vaccine.
This was a randomized, open label, phase III study to assess the immune non-interference, safety, and reactogenicity of Vi-DT typhoid conjugate vaccine when given concomitantly with measles, mumps and rubella (MMR) vaccine. A total of 360 participants aged 9-15 months were enrolled and randomized equally into Vi-DT + MMR (180 participants) or MMR alone (180 participants) group and were evaluated for immunogenicity and safety 28 days post vaccination.
Using the immunogenicity set, difference between proportions (95% CI) of the Vi-DT + MMR group vs MMR alone group were -2.73% (-8.85, 3.38), -3.19% (-11.25, 4.88) and 2.91% (-3.36, 9.18) for sero-positivity rate of anti-measles, anti-mumps and anti- rubella, respectively. Only the lower bound of the range in difference of the proportions for sero-positivity rate of anti-mumps did not satisfy the non-inferiority criteria as it was above the -10% limit, which may not be of clinical significance. These results were confirmed in the per protocol set. There were no safety concerns reported from the study and both Vi-DT + MMR and MMR alone groups were comparable in terms of solicited and unsolicited adverse events .
Results indicated that there is non-interference of MMR vaccine with Vi-DT and Vi-DT conjugate vaccine could be considered as an addition to the EPI schedule among children at risk of contracting typhoid.
伤寒在发展中国家很常见，特别是在印度次大陆和非洲。现有的伤寒结合疫苗（TCV）在 2 岁以下的婴儿和儿童中具有高度的免疫原性。许多国家计划在常规 EPI 计划中于 9 个月大时（接种含麻疹疫苗时）采用 TCV。因此，在尼泊尔对 9-15 个月龄的健康婴儿进行了 Vi-DT TCV 测试，以证明其与含麻疹疫苗不会产生干扰。
这是一项随机、开放性标签、III 期研究，旨在评估当与麻疹、腮腺炎和风疹（MMR）疫苗同时使用时，Vi-DT 伤寒结合疫苗的免疫非干扰性、安全性和反应原性。共有 360 名 9-15 个月龄的参与者被纳入并平均分为 Vi-DT+MMR（180 名参与者）或 MMR 单独组（180 名参与者），并在接种后 28 天评估免疫原性和安全性。
使用免疫原性集，Vi-DT+MMR 组与 MMR 单独组之间比例的差异（95%CI）分别为 -2.73%（-8.85，3.38）、-3.19%（-11.25，4.88）和 2.91%（-3.36，9.18），分别为麻疹、腮腺炎和风疹血清阳性率。只有腮腺炎血清阳性率的比例差异下限不满足非劣效性标准，因为它高于 -10%的界限，这可能没有临床意义。这些结果在方案集得到了证实。研究中没有报告安全性问题，并且 Vi-DT+MMR 和 MMR 单独组在有或无不良反应方面是可比的。
结果表明，MMR 疫苗与 Vi-DT 之间没有干扰，Vi-DT 结合疫苗可以考虑作为 EPI 计划中易感染伤寒儿童的补充。
