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In England, about 100 people have been inoculated with an experimental malaria vaccine in two clinical trials. Now, they no longer have access to the clinical trial staff if that vaccine were to cause an adverse reaction in their bodies. The trial is an effort to find a next-generation vaccine better than the one now used in Africa; that shot protects children against about a third of malaria cases, but researchers hoped to find a vaccine that offered much more protection. Malaria remains a top global killer of children; 600,000 people died of the disease in 2023, the latest figure available.<\/p>\n
Had the trial not been frozen, the participants would be coming to a clinic routinely to be monitored for adverse physical effects, and to have blood and cell samples taken to see whether the vaccine was working. The participants are meant to be followed for two years to assess the vaccine\u2019s safety.<\/p>\n
A scientist who worked on the trial said she hoped that partners at the University of Oxford, where it was being conducted, were shuffling staff to respond if any participant fell ill. But she was fired last week and no longer has access to any information about the trial. She spoke on condition of anonymity because she feared jeopardizing her ability to work on malaria research the U.S. might conduct in the future.<\/p>\n
\u201cIt\u2019s unethical to test anything in humans without taking it to the full completion of studies,\u201d she said. \u201cYou put them at risk for no good reason.\u201d<\/p>\n<\/div>\n<\/div>\n
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Had the stop-work order come later this year, the newly-vaccinated volunteers might have been in an even more precarious position. They were scheduled to be deliberately infected with malaria to see if the experimental vaccine protected them from the disease.<\/p>\n<\/div>\n<\/div>\n
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Dr. Sharon Hillier, a professor of reproductive infectious diseases at the University of Pittsburgh, was until this week director of a five-year, $125 million trial funded by U.S.A.I.D. to test the safety and efficacy of six new H.I.V. prevention products. They included bimonthly injections, fast-dissolving vaginal inserts and vaginal rings.<\/p>\n
With the study suspended, she and her colleagues cannot process biological samples, analyze the data they have already collected, or communicate findings to either participants or the partnering government agencies in countries where the trials were conducted. These are requirements under the Helsinki agreement.<\/p>\n
\u201cWe have betrayed the trust of ministries of health and the regulatory agencies in the countries where we were working and of the women who agreed to be in our studies, who were told that they would be taken care of,\u201d Dr. Hillier said. \u201cI\u2019ve never seen anything like it in my 40 years of doing international research. It\u2019s unethical, it\u2019s dangerous and it\u2019s reckless.\u201d<\/p>\n
Even trials that were not funded in whole or part by U.S.A.I.D. have been thrown into turmoil because they were using medical or development infrastructure that was supported by the agency and is no longer operational. Millions of dollars of U.S. taxpayer funds already spent to start those trials will not be recouped.<\/p>\n<\/div>\n<\/div>\n
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The shutdowns have business consequences as well. Many of those trials were partnerships with U.S. drug companies, testing products they hoped to sell overseas.<\/p>\n
\u201cThis has made it impossible for pharmaceutical companies to do research in these countries,\u201d Dr. Hillier said.<\/p>\n
Another H.I.V. trial, called CATALYST, has thousands of volunteers in five countries testing an injectable drug called long-acting cabotegravir. Participants were receiving bimonthly injections to maintain a sufficient level of the drug in their bodies to prevent H.I.V. infection. Without regular injections, or a carefully-managed end to use of the drug, the participants will not have enough cabotegravir to stop a new infection, but there will be enough in their systems that, if they were to contract the virus, it could easily mutate to become drug-resistant, said Dr. Kenneth Ngure, president-elect of the International AIDS Society.<\/p>\n
This is a significant threat to the trial volunteers and also to the millions of people living with H.I.V. because cabotegravir is closely related to a drug that is already used worldwide in standard treatment of the virus. Development of resistance could be catastrophic, Dr. Ngure said: \u201cIt\u2019s wrong on so many levels \u2014 you can\u2019t just stop.\u201d<\/p>\n
A clinical trial run by the development organization FHI 360, which implemented many U.S.A.I.D.-funded health programs and studies, was testing a biodegradable hormonal implant to prevent pregnancy. Women in the Dominican Republic had the devices in their bodies when U.S.A.I.D. funding was cut off. A spokeswoman for the organization, which furloughed more than a third of its U.S.-based staff this week, said that it had pulled together other resources to ensure that participants continue to receive care.<\/p>\n<\/div>\n<\/div>\n