Uganda In Clinical Trials For Ebola Vaccine

KAMPALA, Uganda — An Ebola vaccine trial is underway in Uganda, as the global search for an effective vaccine continues. The vaccine candidate was co-developed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH), and GlaxoSmithKline (GSK), a United Kingdom-based pharmaceutical company.

The trial vaccine has not been given a name yet as it is in early stages of development, according to NIAID. It is known by its scientific name, ChAd3-EBOZ. The candidate vaccine is based on a type of chimpanzee cold virus, called chimp adenovirus type 3.

The study is being conducted under the auspices of the US Food and Drug Administration agency, the Ugandan National Drug Authority and Uganda National Council for Science and Technology. The principal investigator is Hannah Kibuuka, the executive director of the Makerere University-Walter Reed Project (MUWRP).

The US National Institutes of Health (NIH) and GSK each own intellectual property that underlies this vaccine candidate. GSK is also the manufacturer of the vaccine.

“Given that the vaccine candidate is still in very early stages of development and is not licensed for use, it is too early to set a cost,” GSK said. “However, if successful, the vaccine candidate would be primarily intended for use in people in affected countries, which are some of the poorest in the world and can’t be expected to pay for it. So we’ll look at forming partnerships and finding other ways to make sure that cost isn’t a barrier to access in affected countries.”

A GSK public policy positions document on Intellectual Property & Access to Medicines in Developing Countries states: “We believe we are playing our part through our efforts in research and development, preferential pricing, community investment and innovative partnerships and solutions, such as voluntary licensing.”

The document adds that “access to medicines is a complex and multi-faceted problem. There is no simple answer. The challenges can only be properly addressed through partnership between developed and developing country governments, international organisations, the industry and charitable organizations.”

The vaccine has been tested in the USA and UK in studies of similar size. It is also currently being evaluated for efficacy in later-stage trials in West Africa, including in Senegal, Nigeria, Cameroon and Mali.

“These countries were selected because they neighbour Ebola outbreak countries and have investigators and/or clinical trial sites and infrastructure that GSK has previously used for trials of other vaccines,” according to information obtained from GSK. “Additionally, by conducting the trials in countries neighbouring the Ebola outbreak countries, we hope that this will help prepare the countries and health infrastructure in case of future outbreaks.”

Uganda was chosen as a clinical trial site because scientists in Kampala and at the Makerere University Walter Reed Project (MUWRP) have a strong interest in Ebola vaccine research and have conducted a prior clinical trial examining Ebola and Marburg vaccines. Uganda has had several Ebola breakouts. Before the epidemic in West Africa, the worst outbreak was recorded in Uganda in 2000.

“We are evaluating this vaccine for possible use in an outbreak environment because it is given as a single injection and if it can enlist an immune response quickly, then it will be very beneficial,” Kibuuka said in a press briefing at the launch of the trial phase in November last year.

The primary objectives of the trials are to evaluate the safety and tolerability of the study vaccines administered as single intramuscular injections at two dose levels. The secondary objectives are related to immunogenicity, the property of eliciting an immune response.

The trial enrolled 90 healthy adults, between 18-65 years of age.

Volunteers participating in the trial will be compensated in accordance with NIH and Uganda national guidelines, which are based on the time and inconvenience of participating in the study.

According to GSK, “We believe that there is benefit in continuing to advance a range of vaccines against Ebola as we learn more about their safety and effectiveness and about the different approaches to tackling the disease.”

 

Image Credits: MUWRP