The World Health Organization (WHO) has launched a first-ever clinical efficacy trial for a vaccine from Ebola from the Sudan species of the virus to curb the outbreak in Uganda.
In a statement released by the Agency on Tuesday, stated that this in collaboration with the Uganda Ministry of Health and other partners, adding that the IAVI, the provider of the vaccine, conducted trials for safety and immunogenicity making it the first clinical trial of the vaccine during an outbreak.
According to the Agency, “The principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI), with support from WHO and other partners, have worked tirelessly to get the trial ready in 4 days since outbreak was confirmed on 30 January.
WHO revealed further that the candidate vaccine was donated by IAVI, financially supported by the Agency, the Coalition for Epidemic Preparedness Innovations (CEPI), Canada’s International Development Research Centre (IDRC).
“Also the European Commission’s Health Emergency Preparedness and Response Authority (HERA) and support from the Africa Centres for Disease Control and Prevention (Africa CDC).
In his reaction, WHO’s Director-General, Dr Tedro Ghebreyesus said this is critical achievement towards better pandemic preparedness, and saving lives when outbreaks occur.
“Also UVRI, and research efforts led by WHO involving hundreds of scientists through our research and development Filoviruses network.
The DG on behalf of the Agency thanked the partners for their dedication and cooperation, from IAVI for donating the vaccine, to CEPI, EU HERA and Canada’s IDRC for funding, and Africa CDC for further support. “This massive achievement would simply not be possible without them”, he said.
WHO recalled in 2022, during the previous outbreak of Ebola disease (also from the Sudan species of the virus) in Uganda, it said a randomized protocol for candidate vaccines was developed.
“The randomized vaccine trial to assess the recombinant vesicular stomatitis virus (rVSV) candidate vaccine was launched at a ceremony in Kampala today by the Minister of Health of Uganda.
WHO is co-sponsoring the trial. WHO was represented by Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme and Deputy Director-General, and the WHO representative to Uganda Dr Kasonde Mwinga, along with other colleagues”.
It was reported that three vaccination rings were defined on Monday. The first ring involves about 40 contacts and contacts of contacts of the first reported and confirmed case, a health worker who has died.
Although several promising candidate medical countermeasures progressing through clinical development, as of now, there is no licensed vaccine available to effectively combat a potential future outbreak of Ebola disease from the Sudan species of the virus.
The vaccine for the trial was recommended by the independent WHO candidate vaccine prioritization working group. If the candidate vaccine effective, it can contribute to controlling outbreak and generate data for vaccine licensure.
In 2022, the research teams were trained in good clinical practice (GCP) and standard operating procedures for such trials. They completed refresher training in recent days.
WHO colleagues experienced in trials and in ring vaccination arrived in Uganda over the weekend to support the trial implementation and GCP compliance.
The vaccine doses were pre-positioned in the country. WHO worked with the principal investigators and national authorities and the vaccine developer to review cold chain documentation and ensure the doses were stored correctly over the previous years.
As part of the signed agreement with the Ministry of Health, WHO has a signed agreement with IAVI for additional doses of the candidate vaccine to be made available shortly.