In response to the current outbreak of Ebola caused by the Bundibugyo virus, which originated in the Democratic Republic of the Congo and cases have also been reported in Uganda, WHO has convened multiple expert and advisory groups. These groups evaluated potential vaccines and treatments for both the prevention and treatment of Bundibugyo virus disease (BVD). The WHO Advisory Group recommended that all products identified and studied be used only within clinical trials to generate robust data and ensure safe, ethical and effective research.
WHO held a series of meetings with the WHO Research and Development Blueprint Technical Advisory Group on candidate vaccines and treatments for BVD.
In parallel, WHO convened the Strategic Advisory Group of Experts on Immunization (SAGE) and its Ebola Vaccine Working Group to advise on the potential role of licensed Ebola vaccines during the BVD outbreak.
Main recommendations
Currently, there are no treatments or vaccines specifically approved for the prevention and treatment of BVD. Nevertheless, the WHO advisory group considered several candidate products with sufficient promise to warrant priority for evaluation in clinical trials. WHO is currently working closely with the governments of the Democratic Republic of the Congo and Uganda to facilitate the conduct of research evaluations of these products.
The treatment of the case is as follows.
- Regarding treatment, independent experts recommended prioritizing three therapeutic candidates: the monoclonal antibody MBP134 and maftivimab®, and the antiviral drug remdesivir, for evaluation in studies (i.e., clinical trials) of confirmed BVD cases.
- Combination therapy using monoclonal antibodies and remdesivir is also recommended for evaluation.
To prevent infectious diseases:
- The oral antiviral drug oberdesivir has been identified as the preferred candidate for post-exposure prophylaxis for contacts of confirmed and suspected cases, but experts note that this approach relies on effective contact tracing, which remains operationally difficult in some affected areas of the Democratic Republic of the Congo. Studies on post-exposure prophylaxis include administering oberdesivir tablets to contacts of infected people and evaluating whether this prevents them from developing Ebola.
- The most promising vaccine candidate was determined by experts to be the single-dose rVSV Bundibugyo vaccine (under development by the International AIDS Vaccine Initiative (IAVI)). Development of this single-dose vaccine candidate is expected to take seven to nine months before it is evaluated in clinical trials for its ability to prevent BDV.
- Another vaccine candidate, ChAdOx1 Bundibuggy (under development by the University of Oxford/Serum Institute of India), could be available within two to three months for efficacy evaluation through clinical trials. However, additional animal data are still needed to support and confirm further prioritization. Experts noted that the candidate’s single-dose vaccine approach may be suitable for contacts of Ebola patients, while a two-dose strategy may be considered for high-risk but unexposed populations, such as healthcare workers and front-line responders.
- The convened experts also considered the potential role of Ervevo, the only approved Ebola vaccine. It has been approved for use during the outbreak caused by the Ebola virus, which is most common in Africa. Ortho Ebola virus family. Ervevo is not approved for the prevention of BVD, and evidence for cross-protection against other Ebola virus species remains limited and inconclusive. WHO recommends that Ervebo not be used outside of carefully designed research settings to evaluate its performance against BDV.
Ensuring ethical and safe clinical trials
WHO, the governments of the Democratic Republic of the Congo and Uganda, the African Centers for Disease Control and Prevention (Africa CDC), ANRS Emerging Infectious Diseases (French National Institute for Research on AIDS and Viral Hepatitis), and other scientific partners are working together to develop and implement appropriate protocols to assess the safety and efficacy of priority treatments through clinical field trials.
WHO calls for accelerated access to essential supplies, stronger protection of communities, engagement and trust, and concerted investment in research, development and evaluation to combat BVD.
All research must adhere to the highest ethical standards, under the guidance of national health authorities, and in close consultation with affected communities.
In the meantime, our priority is to stop transmission using the tools we have used in the decades-long response to Ebola: disease surveillance, rapid testing and diagnosis, contact tracing, patient isolation and care, infection prevention and control, community engagement, and safe and dignified burials.
background
The WHO Research and Development Blueprint is a global initiative that enables rapid activation of research and development activities during infectious disease outbreaks. The aim is to rapidly track the availability of proven and effective tests, vaccines and medicines that can be used to save lives and avert large-scale crises.
SAGE is WHO’s main advisory group on vaccines and immunization. The agency is tasked with advising WHO on global policies and strategies, from vaccines and technology and research and development to the implementation of immunizations and links with other health interventions.
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