EG arm injection

The world needs a malaria vaccine.

疫苗s are the most cost effective and efficient method of protecting against infectious diseases. Smallpox was eradicated using a vaccine. This is the only human infectious disease ever eradicated. Diseases once widespread, are now close to eradication (polio, measles), because of the deployment of effective vaccines. However, malaria, one of the oldest and deadliest diseases in human history, remains without a marketed vaccine.

In 2016,WHO reportedthat there were 216 million cases of malaria and an estimated 445,000 deaths worldwide, the majority of cases occurring in Sub-Saharan Africa, These numbers were increased compared to 2015. Malaria experts have spent decades trying unsuccessfully to develop a vaccine against this complex, eukaryotic parasite. Out of necessity, anti-malaria programs have therefore focused on control using more conventional methods to decrease contact between infected mosquitoes and people or treating people with drugs. However, recent advances in malaria innovation have put us close to developing a malaria vaccine capable of effective protection that can be produced on a large scale.

A sporozoite-based malaria vaccine targeting infection.

Since 2003, the biotech companySanariaInc. has been working to creating an effective malaria vaccine. Sanaria has developed unique technologies to manufacture vaccines, soon at phase 3 compliance, that are composed ofPlasmodium falciparum(Pf) sporozoites (SPZ). These PfSPZ are attenuated either by irradiation (Sanaria® PfSPZ Vaccine) when still in the mosquito, by malaria drugs (Sanaria® PfSPZ-CVac) during liver or early blood stages, or by gene deletion (Sanaria® PfSPZ- GA1). These vaccine candidates induce powerful T cell responses in the liver that prevent infection from Pf, and thereafter the development of blood stage parasites and transmission of blood sexual stages to the mosquito. All three vaccines are being tested in human volunteers with very encouraging results summarised in the Table. Table References1),2),3),4),5).

Malaria control in Equatorial Guinea.

An important partner in this exciting work is the Government of Equatorial Guinea (EG) which, along with three private party funders, Marathon Oil Corporation, Noble Energy and Atlantic Methanol Production Company, have committed to furthering the development of PfSPZ Vaccine to the point where it can be tested in an ambitious demonstration project for Pf elimination.

例如，西非中部是一个疟疾的流行国家。疟疾人口约有100万居民，是该国的生命事实。2004年，政府和私人各方建立了一个公私伙伴关系，在过去的15年中，控制了疟疾on Bioko Islandand parts of the mainland in an effort to reduce malaria’s burden on the population.

The Bioko Island Malaria Control Project (BIMCP) implemented by the U.S. NGO,Medical Care Development International (MCDI)and the Ministry of Health and Social Welfare of the Government of EG, has reduced malaria prevalence from 74% (by thick blood smear) in 2003 to 11% (by rapid diagnostic test) in 2017 in 2-14-year olds, infant mortality due to malaria infection by 85% (by rapid diagnostic test), and anemia by similar numbers. However, it has proven difficult to eliminate malaria from the region despite the increased intensity of malaria interventions. MCDI and its funders, recognizing the challenges being faced in such an endemic environment decided in 2013 to partner with Sanaria, theIfakara Health Institute(IHI, Tanzania), and theSwiss Tropic and Public Health Institute(Swiss TPH) to form theEquato-Guinean Malaria Vaccine Initiative(EGMVI).

通过疫苗开发建立全球卫生研究的能力。

目的啊f the EGMVI is to conduct a series of clinical trials that will advance PfSPZ Vaccine through to phase 3 clinical trials and eventually test the public health utility of the vaccine in malaria elimination projects. To do this, the EGMVI is training a cohort of national clinicians and nurses, laboratory technicians, data managers, and community managers, who will eventually form the nucleus of the first EG public health institute.

The clinical trials are testing PfSPZ Vaccine and PfSPZ-CVac for safety and efficacy in EG. The EGMVI is unique in that the project has managed to conduct the country’s first human subject clinical trials using an investigational product according to international standards of good clinical practice and safety, as well as put the first Equatoguinean researchers on the map in terms of vaccine research. For instance, in April 2018, Equatoguinean EGMVI researchers, along with their Equatoguinean colleagues in the BIMCP, will present 15 papers and posters at the Multilateral Initiative on Malaria meeting in Dakar, Senegal.

EGMVI也是EGMVI所独有的，这是EG和Tanzania之间建立的南南合作。这项合作导致在坦桑尼亚Bagamoyo的IHI中心进行了广泛的培训，以使Equatoguinean员工在使用人类受试者进行临床试验的情况下加快速度。IHI员工在EG中进行了前两个试验方面发挥了重要作用。这项工作包括担任首席研究员，协调临床试验并运行处理临床样本和试验数据所需的实验室。EG与坦桑尼亚卫生部之间的会议探讨了两国之间未来的合作。

Lastly, the EGMVI opportunity has opened other doors for the EG Ministry of Health and Social Welfare, whereby EG has been invited to participate in the African Vaccine Regulatory Forum and is a sitting member of the International PfSPZ Consortium. Future efforts will be sought to have EG participate in pan African initiatives through WHO – AFRO and UNICEF.

迄今为止，EGMVI已在168名6个月至65岁的志愿者中测试了PFSPZ疫苗或PFSPZ-CVAC。安全性和宽容性非常出色，更重要的是，招募参与者的社区已成为EGMVI和EG的重要合作伙伴，并为消除该国消除疟疾的解决方案而努力。通过完成安全试验，下一步是进行试验以优化PFSPZ疫苗的剂量方案。随后将在2019年进行的3阶段研究，旨在评估Bioko岛特有疟疾环境中PFSPZ疫苗的安全性，耐受性和保护性功效。

An integrated approach to eliminate malaria from Bioko Island.

EGMVI目标是第一的位置sub-Saharan Africa to eliminate malaria using a vaccine in addition to standard malaria control efforts. The long-term plans are to combine standard malaria control – insecticide treated bednets, indoor residual spraying, larval control, diagnosis and treatment, and mass drug administration – with high coverage of PfSPZ Vaccine in the whole population to halt transmission and eliminate malaria, initially from foci in a cluster randomized study, and eventually from the whole of Bioko.

We look forward to sharing that story as it unfolds over the next few years.