A Randomized Double-blinded Phase 1 Clinical Trial to Assess Safety, Tolerability and Reactogenicity of the Pan-Malaria Transmission-Blocking Vaccine AnAPN1 in Healthy Adults Living in Gabon
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Adverse events related to the vaccination.
研究概览
简要总结
Malaria is still responsible for more than 627,000 deaths each year, predominantly among children under 5 years old. Current reductions in deaths have stagnated, and additional setbacks for malaria control programs due to the Coronavirus Disease 2019 (COVID-19) pandemic are expected. To achieve malaria elimination and eradication a leverage concerted approaches to reduce clinical disease and prevent new infections is a must. The existing malaria controls tools including the a recombinant protein-based malaria vaccine (RTS,S ,(trade name MosquirixMosquirix )), a malaria vaccine currently undergoing implementation studies and endorsed by the World Health Organization on October 7, 2021, can reduce disease burden for patients but cannot ultimately support malaria elimination and eradication since their effect on malaria transmission is at most partial. Consequently, complementary interventions, such as transmission-blocking vaccines (TBVs) may prove to be a cost-effective intervention that can reduce on-going residual transmission and the cascade of new infections.
详细描述
TBVs work by blocking parasite transmission to and from mosquitoes, with the added benefit of preventing the spread of parasites that have developed drug resistance or those that are vaccine-escape mutants of e.g. RTS,S. However, blocking transmission of all malaria species will be mandatory to achieve a globally relevant impact on malaria morbidity and mortality with Plasmodium falciparum and Plasmodium vivax being the most relevant targets. To date, the mosquito recombinant protein antigen vaccine Anopheline Alanyl Aminopeptidase N (AnAPN1)is the only TBV candidate that meets this need, wherein antibodies to this vaccine block both human malaria parasite species, underscoring its potential for supporting malaria elimination. The AnAPN1 vaccine consists of the AnAPN1 dimer antigen construct (UF6b) construct derived from the sequence of a protein of the mosquito midgut (Anopheles gambiae alanyl aminopeptidase), expressed as a recombinant protein in bacteria. With Global Health Innovative Technology Fund( GHIT) (G2020-208) support, the AnAPN1 reaches the First-In-Human milestone.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Positive for P. falciparum sexual and asexual stages by thick blood smear microscopy on admission and documented parasitologically confirmed malaria parasites of at least 1000 parasite/microliter in the past four weeks.
- •Pregnancy, lactation, or intention to become pregnant during the trial.
- •Previous participation in a malaria vaccine trial.
- •HIV and microscopically detectable schistosomiasis and Soil-Transmitted helminth infection.
研究组 & 干预措施
Dosage A1
n=2 will receive a dose of 20 mcg UF6b (A1), n=9 will receive 20 mcg AnAPN1: GLA-LSQ (5 mcg GLA/2 mcg LSQ) (A2)
干预措施: Vaccine AnAPN1 (Drug)
Dosage B1
n=2 will receive 50 mcg UF6b (B1), n=9 will receive 50 mcg UF6b: GLA- LSQ (12.5 mcg GLA/5 mcg LSQ) (B2)
干预措施: Vaccine AnAPN1 (Drug)
Dosage C1
n=2 will receive 100 mcg UF6b (C1); n=9 will receive 100 mcg UF6b: GLA- LSQ (25 mcg GLA/10 mcg LSQ) (C2)
干预措施: Vaccine AnAPN1 (Drug)
结局指标
主要结局
Adverse events related to the vaccination.
时间窗: Day 14
Number and grade of adverse events possibly, likely, and definitely related to vaccination.
次要结局
- anti-UF6b IgG concentration(Day 28)
研究者
Prof. Ayola Akim ADEGNIKA
Professor
Centre de Recherche Médicale de Lambaréné