相关临床试验
24
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1979
进行中（未招募）
2
8.3%
已完成
17
70.8%
尚未招募
1
4.2%
Unknown
4
16.7%
暂无批准数据
- Kenya launched the Health Products and Technologies Local Manufacturing Strategy 2026–2030 on 23 June 2026, aiming to expand domestic production of medicines, vaccines, diagnostics, and medical devices. - The country currently imports 70–80% of its pharmaceuticals, spending over USD 760 million annually on imports out of a USD 1.2 billion market. - The strategy targets a 70% increase in utilization of existing manufacturing capacity by 2030 and includes multi-year procurement commitments to incentivize local supply. - Japan committed KSh 3 billion to support Kenya's vaccine manufacturing agenda through KEMRI and the Kenya BioVax Institute, alongside regulatory cooperation efforts.
- A new €15.3 million EU-funded project, ACT-CHIK, will conduct a Phase Ib/III trial of the MV-CHIK chikungunya vaccine across Rwanda, Kenya, Nigeria, and Senegal, enrolling 940 participants including adults, adolescents, and children. - The MV-CHIK vaccine uses a measles virus Schwarz strain vector and has demonstrated satisfactory safety and immunogenicity in six prior Phase I/II trials involving approximately 600 adults. - The four-year initiative will prepare technology transfer of vaccine manufacturing to Institut Pasteur de Dakar, Africa's only WHO-prequalified vaccine manufacturer, supporting the African Union's goal of producing 60% of vaccines locally by 2040. - The international consortium spans seven partners across four continents, coordinated by Institut Pasteur, with the International Vaccine Institute serving as clinical trial sponsor.
- The SAFIRE project has initiated a first-of-its-kind Phase III adaptive platform trial testing two artemisinin-based combination treatments in first-trimester pregnant women across Mali, Burkina Faso, and Kenya. - Currently, only one ACT (artemether-lumefantrine) is recommended for first-trimester use; the trial compares pyronaridine-artesunate and dihydroartemisinin-piperaquine against the standard of care. - Over 12 million pregnant women in sub-Saharan Africa are exposed to malaria annually, yet just 4% of clinical trials over the past decade allowed inclusion of pregnant women. - A separate KEMRI-led study published in The Lancet found that adding dihydroartemisinin-piperaquine to daily co-trimoxazole reduced malaria infections by 68% in pregnant women living with HIV.
- Tonix Pharmaceuticals presented preclinical data for TNX-801, a live attenuated horsepox-based vaccine candidate designed to protect against mpox and smallpox with single-dose administration. - The vaccine demonstrated strong neutralizing antibody responses and protected animals from clinical disease and mortality in non-human primate, rabbit, and murine models for at least 14 months. - TNX-801 showed favorable safety profiles across multiple administration routes and may offer advantages over existing vaccines through durable T-cell responses and potential for large-scale manufacturing. - The company has received FDA guidance for clinical development and announced collaboration with Kenya Medical Research Institute for Phase I trials.
- The BOHEMIA trial, the largest study on ivermectin for malaria to date, demonstrated a 26% reduction in new malaria infections when administered alongside standard bed nets in Kenya. - Over 20,000 participants in Kwale County, Kenya received monthly ivermectin doses for three consecutive months, showing significant malaria reduction with only mild, transient side effects. - The World Health Organization's vector control advisory group has reviewed the findings and recommended further studies, marking a potential breakthrough in malaria control strategies. - Beyond malaria prevention, ivermectin treatment provided additional benefits including reduced prevalence of scabies, head lice, and bed bugs in treated communities.
- A new mango-flavored pill combining two anti-parasitic drugs demonstrates promising results in clinical trials for treating intestinal worms. - The fixed-dose combination of albendazole and ivermectin aims to improve efficacy and reduce the risk of drug resistance in treating soil-transmitted helminths. - Clinical trials involving children in Ethiopia, Kenya, and Mozambique showed the pill's effectiveness, with regulatory decisions expected in early 2025. - Further trials are planned in Kenya and Ghana to assess the pill's impact on a larger population, potentially aiding WHO goals for disease elimination.
- The US Food and Drug Administration has suspended the license for Valneva's Ixchiq chikungunya vaccine following four additional cases of severe side effects, primarily affecting patients aged 70 to 82. - The suspension comes amid growing global chikungunya threats, with Europe recording 27 outbreaks this year and the WHO warning of potential epidemic risks similar to the 2004 Indian Ocean outbreak. - Valneva's shares dropped over 26% following the announcement, though the company maintains its commitment to global vaccine access and continues investigating the reported adverse events. - The regulatory action highlights safety concerns particularly among elderly populations, as all reported cases showed symptoms consistent with previous clinical trial observations in this demographic.
• Kenya Medical Research Institute (KEMRI) urges the government to approve Cabotegravir and Lenacapavir, two highly effective HIV prevention drugs, to reduce the nation's HIV burden. • Clinical trials show Cabotegravir, an injectable drug by GlaxoSmithKline, surpasses oral PrEP efficacy, while Lenacapavir, from Gilead Sciences, offers near 100% prevention with six-month injections. • Despite FDA and EMA approvals, Kenya's Pharmacy and Poisons Board has been slow to approve Cabotegravir, hindering access to advanced HIV prevention methods. • With 1.6 million Kenyans living with HIV/AIDS, KEMRI emphasizes that approving these drugs could significantly decrease new infections and save lives.
- Tonix Pharmaceuticals collaborates with KEMRI to develop TNX-801, a live-virus vaccine, for mpox prevention. - A Phase I clinical study in Kenya will assess the safety, tolerability, and immunogenicity of TNX-801. - TNX-801 aligns with WHO's target product profile, offering single-dose, durable protection against mpox. - Preclinical data showed TNX-801's efficacy in animal models, preventing clinical disease and reducing viral shedding.
