Evaluation of Immunogenicity and Safety of a New Vaccine Schedule Using the Vaccine Candidate Sm14 Against Schistosomiasis in Adults With a History of S. Mansoni and / or S. Haematobium Infection.

Oswaldo Cruz Foundation1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2022年7月1日最近更新: 2022年12月21日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 120
试验地点: 1
主要终点: assessment of Immunogenicity 1

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Previous clinical trials have already demonstrated the safety of the candidate vaccine in adults as well as in children, in good health or infected with schistosomiasis. Regarding the induced immune response, more than 80% of vaccinated subjects were seroconverted after three vaccine injections. The induced immune response was substantial but transient. In order to obtain a more lasting immune response, the investigator will experiment with a new vaccination schedule (2 injections 1-month interval and the 3rd injection 5 months after the first dose), versus the vaccine schedule initially used (3 injections at 1-month interval).

This trial will be the last phase 2 before testing the efficacy of the rSm14 vaccine candidate.

详细描述

Adults with a history of infection with S. mansoni and / or S. haematobium, aged 18 to 49 years, pretreated with PZQ before the first vaccine injection (Inclusion) and living in villages in the Saint Louis region where schistosomiasis is endemic.

Comparative test with modification of the vaccine schedule previously used:

The reference vaccine administration schedule consists of three vaccine administrations one-month interval (Group Vacc3).
The new vaccine injection schedule will consist of a primary vaccination with two administrations of the vaccine one month apart, then a booster five (5) months after the first injection (Group Vacc2+1). Immunogenicity and safety will be evaluated and compared in these 2 groups.

These two groups of adults will be formed after randomization and pretreatment with PZQ (4 to 8 weeks before their first vaccine administration).

Main objective: to compare the immunological quality of the new vaccination schedule (amplitude and duration) versus the vaccination schedule used in the previous trials, by studying the Sm14 specific antibody response induced both quantitatively and qualitatively. The hypothesis is to obtain a mean response quantitatively higher with the new vaccine schedule.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

盲法说明

open label

入排标准

年龄范围: 18 Years 至 49 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Man living in villages in the Saint Louis region where schistosomiasis is endemic.
•Having an infectious history of schistosomiasis.
•Adult between 18 and 49 years old at the time of the first injection.
•Have received pre-treatment with PZQ four to eight weeks before inclusion.
•Consent signed by the volunteer after information.
•Satisfactory state of health, confirmed on clinical examination and following biological assessment (Vpi / W-1).
•Available for the duration of the trial.
•To be negative to the Covid-19 antigenic test

排除标准

•(Non inclusion criteria) :
•Subject not meeting one of the inclusion criteria.
•Participation to a previous anti-schistosomiasis vaccine clinical trial.
•Participation in another ongoing clinical research
•Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immune modulating drugs.
•Known hypersensitivity to any component present in the Sm14 vaccine, or to any given vaccine, and / or history of allergic disease.
•Acute illness at the time of inclusion.
•Other conditions which, according to the PI, can potentially represent a danger to the subject to be included.