NIH will send 100 doses of experimental Ebola treatment to Congo

Anthony Fauci
Anthony S. Fauci

The NIH will ship 100 doses of an experimental Ebola virus treatment to the Democratic Republic of the Congo next week, filling a request from health officials there to use the treatment in a clinical trial during the current outbreak, National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, told Infectious Disease News.

The monoclonal antibody mAb114 was isolated from a survivor of the 1995 Ebola outbreak in Kikwit, Democratic Republic of the Congo (DRC), who still had antibodies against the deadly disease 11 years after infection. It has been shown to protect monkeys from Ebola virus infection but has only recently been tested in humans.

“It’s kind of nice that it came full circle. An antibody that we derived from one of their citizens is now going back there to potentially help them,” Fauci said.

The DRC is currently experiencing its ninth Ebola outbreak since the virus was discovered in the country in 1976. As of Thursday, the DRC reported 52 cases and 22 deaths in the current outbreak, including 31 confirmed infections. The outbreak is occurring in three areas, including the large city of Mbandaka, where more than 1 million people live.

The virus’ spread from a remote area to an urban population center has worried experts. There had been as many as 10 suspected cases reported from Mbandaka, but the latest update from the DRC health ministry showed that half of them tested negative for the virus.

The NIH began testing the safety and tolerability of mAb114 in humans in a phase 1 trial last week, Fauci said. The treatment works by binding to the hard-to-reach core of the Ebola virus surface protein, blocking its interaction with human receptor cells, according to the NIH.

The first three study participants will receive the treatment intravenously for 30 minutes at a dose of 5 mg per each kilogram of their body weight. Depending on the safety data, future participants may receive a higher dose.

Fauci said a “modest cold chain” was being established to ship freeze-dried doses of mAb114 to the DRC, where they can be reconstituted in the field with fluid. The doses do not need to be kept at extremely low temperatures like the experimental vaccine that is currently being used in a ring vaccination trial in the DRC.

He said there was no hesitation about sending an experimental treatment into the field before its safety in humans was established.

“That’s not unusual in an emergency situation,” Fauci said. “If they use it in a trial or under compassionate use, informed consent would have to make it very clear that it hasn’t completed a phase 1 trial.” – by Gerard Gallagher

Disclosure: Fauci reports no relevant financial disclosures.

Anthony Fauci
Anthony S. Fauci

The NIH will ship 100 doses of an experimental Ebola virus treatment to the Democratic Republic of the Congo next week, filling a request from health officials there to use the treatment in a clinical trial during the current outbreak, National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, told Infectious Disease News.

The monoclonal antibody mAb114 was isolated from a survivor of the 1995 Ebola outbreak in Kikwit, Democratic Republic of the Congo (DRC), who still had antibodies against the deadly disease 11 years after infection. It has been shown to protect monkeys from Ebola virus infection but has only recently been tested in humans.

“It’s kind of nice that it came full circle. An antibody that we derived from one of their citizens is now going back there to potentially help them,” Fauci said.

The DRC is currently experiencing its ninth Ebola outbreak since the virus was discovered in the country in 1976. As of Thursday, the DRC reported 52 cases and 22 deaths in the current outbreak, including 31 confirmed infections. The outbreak is occurring in three areas, including the large city of Mbandaka, where more than 1 million people live.

The virus’ spread from a remote area to an urban population center has worried experts. There had been as many as 10 suspected cases reported from Mbandaka, but the latest update from the DRC health ministry showed that half of them tested negative for the virus.

The NIH began testing the safety and tolerability of mAb114 in humans in a phase 1 trial last week, Fauci said. The treatment works by binding to the hard-to-reach core of the Ebola virus surface protein, blocking its interaction with human receptor cells, according to the NIH.

The first three study participants will receive the treatment intravenously for 30 minutes at a dose of 5 mg per each kilogram of their body weight. Depending on the safety data, future participants may receive a higher dose.

Fauci said a “modest cold chain” was being established to ship freeze-dried doses of mAb114 to the DRC, where they can be reconstituted in the field with fluid. The doses do not need to be kept at extremely low temperatures like the experimental vaccine that is currently being used in a ring vaccination trial in the DRC.

He said there was no hesitation about sending an experimental treatment into the field before its safety in humans was established.

“That’s not unusual in an emergency situation,” Fauci said. “If they use it in a trial or under compassionate use, informed consent would have to make it very clear that it hasn’t completed a phase 1 trial.” – by Gerard Gallagher

Disclosure: Fauci reports no relevant financial disclosures.

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