26/04/21

疟疾疫苗“首先达到谁达到疗效目标”

疟疾疫苗试验
世界第一次有严重的疟疾疫苗候选者。版权:陆军医学((CC BY 2.0

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  • 疟疾疫苗候选者显示450名儿童的测试功效77%
  • Final stage clinical trials begin in May, paving way to registration
  • Success would represent huge step towards 2030 goal of malaria elimination

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[ouagadougou]malaria科学家说,对西非儿童进行测试的疫苗候选人的疗效约为77%,这是对疾病斗争的突破。

疟疾causes more than 400,000 deaths a year globally, according to the World Health Organization (WHO), mostly among children in Sub-Saharan Africa.

R21/基质-M疫苗,由Nanoro临床研究单元(CRUN)开发,Burkina Fasoand their partners at theUniversity of Oxford在英国,是第一个达到世卫组织设定的75%疗效目标的疟疾疫苗。

Researchers recruited 450 children aged five to 17 months in the area of Nanoro, central Burkina Faso, and divided them into three groups for the Phase IIb trial.

“We believe that the solution against malaria will come from Burkina. We encourage the team to continue the third phase so that a vaccine is put on the market that will allow us to reduce morbidity and mortality from malaria,”

Charlemagne Ouedraogo, Minister of Health, Burkina Faso

One group of 150 received the vaccine with a low dose of the Matrix-M adjuvant, which helps create a stronger immune response. Another group of 150 received the vaccine at a higher dose of adjuvant, while the last group of 150 received the rabies vaccine as a control vaccine.

Halidou Tinto, principal trial investigator at the CRUN, said: “Once we vaccinated them with three doses one month apart […], we followed them in each group to see how they were going to behave in terms of vaccine safety, tolerance, but also efficacy.”

During 12 months of follow-up, the vaccine was found to be 77 per cent effective in the group that received the highest dose of adjuvant and 71 per cent in the lower dose group, researchers said.

他们补充说,研究中的受试者报告说,疫苗没有严重的副作用,该疫苗被发现是安全的,可以大规模以低成本制造。

尽管超过100个候选疫苗entering clinical trials in recent decades, none have previously reached the target of 75 per cent efficacy which the WHO set as a target to be achieved by 2030.

印度血清研究所, which has manufactured the vaccine, says it will be able to deliver more than 200 million doses of the vaccine once it is approved by regulators.

布基纳法索国家疟疾控制计划协调员的流行病学家高迪尔·塔古里(Gauthier Tougouri)称赞这项研究是在反对疟疾斗争中取得的重大成就。

Last year the country recorded more than 11 million cases of malaria and almost 4,000 malaria-related deaths, including pregnant women and children, official figures show.

现在将进行较大的III期试验,涉及四个国家的4,800名五​​到三岁的儿童。

“I hope that the forthcoming results will confirm phase two of the study so that we can reach the 2030 target for the elimination of malaria,” said Tougouri.

在布基纳法索(Burkina Faso),将从下个月开始在该国西南部的纳米罗(Nanoro)和丹德(Dande)的下一阶段招募儿童。

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“It is important for us to see if such a vaccine, tested in an area like Nanoro which has a transmission of medium duration, will give the same effectiveness in an area like Dande where the transmission is much longer,” explained Tinto.

Researchers hope that by testing the vaccine in different contexts on a larger number ofchildren,将确认其功效,并可以考虑进行疫苗进行注册。

Charlemagne Ouedraogo, Minister of Health for Burkina Faso, said the findings offer hope for the elimination of malaria in the country and across the continent.

“We believe that the solution against malaria will come from Burkina. We encourage the team to continue the third phase to give us results that will allow us to go further so that a vaccine is put on the market that will allow us to reduce morbidity and mortality from malaria,” he said.

Ida Sawadogo, programme officer at the Access to Essential Medicines Network, said: “We have been waiting for this for years and we are happy that at last a vaccine is being found against this disease which is the number one killer in our country.”

This article was produced by SciDev.Net’s Sub-Saharan Africa French edition and edited for brevity and clarity.

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