LONDON – The first patient has been enrolled in an Ebola treatment trial in the Democratic Republic of the Congo, and two drugs are being tested in the Ituri region in a program set up just six weeks after the Ebola outbreak was declared, according to the Guardian.
Meanwhile, another vaccine against the Bundibugyo strain of Ebola will be tested on humans after British regulators granted permission to carry out trials, according to the BBC.
There are other vaccines in development.
These include products from biotech company Moderna, which use mRNA vaccine technology. The U.S.-based International AIDS Vaccine Initiative and Public Health vaccine uses the same technology that has proven effective for another type of Ebola, but it takes longer to produce.
Scientists say it is a record pace to set up and begin this type of research, with patients enrolled in treatment trials just six weeks after the WHO declared it a public health emergency of international concern.
Scientists at the University of Oxford began developing the vaccine eight weeks before a public health emergency was declared on May 17th.
Volunteers are being recruited and the first vaccinations are expected to be administered to healthy adults in the UK “within a few weeks”.
At least 625 people have died so far from the Ebola outbreak, which is centered in the Democratic Republic of the Congo.
It is caused by the Bundibugyo strain of Ebola, which has caused two outbreaks so far.
The six different Ebola strains are known as “sisters, not twins” because they look similar but require different treatments and vaccines. That means there is no approved drug or vaccine this time.
The outbreak is still uncontrolled and is occurring in conflict zones with significant population movement, increasing the need for vaccines to stop the spread of the disease.
Dr Katrina Pollock, the trial’s lead researcher based at the University of Oxford, told the BBC: “We are always conducting phase 1 (early stage) trials of new vaccines to prepare for exactly this kind of outbreak.”
The trial will involve 50 healthy adults between the ages of 18 and 55. Researchers are also working with partners in Uganda to prepare for trials in Africa.
The volunteers will be monitored for a year, but scientists need to know soon whether the vaccine is eliciting the right kind of immune response or if there are any unexpected side effects.
The Oxford team shot to fame during the coronavirus pandemic and was able to develop the vaccine in a matter of weeks because it uses the same technology used in the Oxford/AstraZeneca coronavirus vaccine.
Using a cold virus to infect chimpanzees that has been genetically modified to increase safety.
It works like an envelope, and all the researcher needs to do is change the letter inside before dropping it into the body.
With Covid, the letter delivered was a piece of genetic code from the Covid virus.
This time it is an excerpt from Bundibugyo species of Ebola hemorrhagic fever.
The vaccine does not cause an infection, but a piece of genetic code starts producing one of the viral proteins from the Ebola virus in the body.
This is enough to trigger the immune system to recognize the threat and mount an immune response.
This means that if you actually encounter the Ebola virus, your body should already have a head start.
The vaccine has been developed and tested on mice and macaque monkeys and manufactured to clinical standards by the Serum Institute of India. Approximately 620,000 doses have been manufactured and stockpiled.
Based on that data, the UK’s Medicines and Healthcare products Regulatory Agency gave the green light for human trials.
“As soon as we heard there was an outbreak, we were able to scale up really quickly,” vaccine researcher Alex Sampson told the BBC.
Vaccines typically take up to 10 years to research, develop and prove effective. But Sampson says he hasn’t cut corners.
“We’re doing all the same tests that we normally do, only we can run them in parallel, which means we have many teams working around the clock in different locations, but we’re still doing everything as usual,” he added.
The Oxford coronavirus vaccine is estimated to have saved six million lives in its first year of use around the world, with hundreds of millions of doses administered.
However, the vaccine had limited use in some countries due to rare blood clots that affect up to 1 in 100,000 people.
The vaccine may carry similar risks, but they are much lower than the threat posed by the Bundibugyo strain of Ebola, which kills about a third of those infected.
Mr Pollock said serious side effects were “extremely rare” and that he was thinking “very deeply” about the impact of the trial on healthy people and would communicate any risks to volunteers.
“I would like to underline that the new AstraZeneca vaccine has been safely administered to millions of people,” he added.
As of July 9, there have been 1,792 confirmed cases and 625 deaths from the Bundibugyo strain of the virus, for which there is no vaccine or approved treatment.
Hope for turning the tide now rests with scientists searching for effective drugs.
The PARTNERS (Platform Adapted Randomized Trial for Novel and Repurposed Filovirus Therapies) trial was launched in the Democratic Republic of the Congo, enrolling two drugs: remdesivir and MBP134. Patients are randomly assigned to receive either drug, a combination of the two, or simply standard supportive care.
Remdesivir is an antiviral drug manufactured by pharmaceutical company Gilead Sciences, while MBP134 is a monoclonal antibody developed by Map Biopharmaceutical that contains two specially designed immune proteins that recognize and neutralize the virus.
Both are administered intravenously. MBP134 is administered as a one-time infusion and remdesivir is administered as a 10-day intravenous therapy.
“These two drugs have indeed been proven to be effective against Bundibugyo virus in animal models,” said Professor Laurence Riesenborgs of the Antwerp Institute of Tropical Medicine, who is working on the trial in Ituri.
“They showed great efficacy, but now we need to test it in humans. Basically, what we want to know is whether they can really reduce mortality.”
The mortality rate for Bundibugyo is typically lower than that of the Zaire strain of Ebola that has caused major outbreaks, but it still kills about one in three people infected.
Researchers are closely monitoring whether there are any differences in mortality rates between groups given the experimental drug and those given standard treatment. “Any improvement is a good thing,” Riesenborgs said. “But we need to see a significant reduction because we need to detect it statistically.”
He said a trial investigating the effect of monoclonal antibodies on Ebola cases caused by the Zaire strain reduced mortality rates from 50% to 35%. “I hope we see something on that scale.”
The design of this trial allows for the addition of other potential treatments as they become available. Riesenborgs said the study will likely need to enroll 700 to 1,000 patients to get results.
“We have opened one site and we hope to open additional sites soon if possible, but obviously it will still be several months depending on the infection situation.”
WHO officials said remdesivir and MBP134, equivalent to 1,200 registered patients, were donated by Gilead and the US government, respectively. The WHO said it was in discussions to ensure adequate supplies should the drug prove safe and effective after testing.
Patients of all ages can participate in the trial, including pregnant and breastfeeding women who are often excluded from medical research.
“We always consider risk and benefit,” Riesenborgs says. “The benefits in this case could be very high because we are providing potentially life-saving treatment to people who are at a very high risk of dying.”
“It’s really great that we’ve been able to get started so early,” says Professor Amanda Rozek, International Principal Scientist at Partners at the University of Oxford.
She said strong scientific leadership in the DRC, which has hosted large-scale clinical trials during early outbreaks of Ebola and other diseases such as mpox, was essential.
“Looking back at West Africa (where the Ebola outbreak occurred between 2014 and 2016, with over 28,000 infections and over 11,000 deaths), it took more than a year to start clinical trials, but I am extremely proud of the team led by INRB (National Institute of Biomedical Research in the Democratic Republic of the Congo) who were able to achieve clinical trials in just six weeks after the outbreak was first announced.”
Rozek said the focus was on keeping the trial as simple as possible, similar to the COVID-19 recovery trial conducted by the same Oxford University group.
PARTNERS is sponsored by WHO and receives funding from the Wellcome Trust, FCDO and UKRI.
Professor Yap Boum, head of emergency response at Africa CDC, the continent’s health watchdog, warned that the danger was not over, but added: “What limits outbreaks is our ability to provide care, our ability to monitor, and our ability to isolate people. These trials allow us to get treatment. And when we treat people, it also sends a message to the community.”
Another trial is scheduled to begin this week to test whether giving a drug called oberdesivir to people who came into contact with the Bundibugyo case can stop them from developing the disease.
The Africa CDC said about $18 million is needed to move forward with the trial, with $6 million pledged to date.
