A Q&A with Dr. Alemnew Dagnew of the Gates Medical Research Institute

Last week, I shared an article from The Star about the launch of the Phase 3 clinical trial of the M72 vaccine in Kenya.  On the heels of the trial launch, I posed a few questions to Dr. Alemnew Dagnew, the Gates MRI M72 clinical trial lead. Here is a look inside our conversation:

I am always interested to hear the stories of my colleagues – why did you choose to work in public health? And at the Gates MRI? 

I grew up in rural Ethiopia. Upon leaving medical school, I worked at a local health center and then I did postgraduate studies, including TB research. I know the burden of TB firsthand from my practice as a physician and researcher in Ethiopia, as I saw the impact of TB on families and communities. It shocked me to see how this disease ravages communities.

I gained research experience in pharmaceutical companies and the role at the Gates MRI afforded me the opportunity to have an impact at a macro level, working as a clinical lead on TB.

What are the objectives of this Phase 3 clinical trial?  

The trial will evaluate the vaccine efficacy (VE) of M72 in the prevention of laboratory-confirmed pulmonary TB among IGRA-positive participants. If shown to be well-tolerated and effective with an acceptable safety profile, M72 could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century.   

Trial participants will receive either the investigational M72 vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.  

Kenya is the second country to initiate the trial – how did you select the countries and the sites that will take part? 

To evaluate whether a vaccine is providing protection, it needs to be studied in populations at high risk of developing TB. The trial sites in the seven countries where the vaccine is being tested, which includes five sites in Africa, planned to enroll participants from communities with the highest risk of TB. At full capacity, the trial will include approximately 20,000 participants, including people living with HIV, at up to 60 trial sites in South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. These countries each have considerable experience with TB and vaccine-related clinical trials and a strong track record for protecting patient safety and generating the high quality data that’s essential for regulatory approvals.

What is the role of partnerships and international cooperation in the fight against TB?  

International collaboration is a vital element in the fight against TB, and the partnership between the Gates MRI, GSK, the Gates Foundation and Wellcome has been pivotal in driving the progress of the M72 program.

Following your visits to the sites, could you please talk about the communities we are working to serve, and the impact of TB on these neighborhoods? 

I am constantly inspired by our mission at the Gates MRI: to serve the underserved. In 2022, 10.6 million people were diagnosed with TB. TB is not only a health problem, but also a socioeconomic problem. Challenges that disproportionately impact LMICs – such as overcrowding, malnutrition, and limited access to health care – also drive-up TB cases, exacerbating these cycles. TB also keeps people out of work and school and leads to disastrous costs that reinforce cycles of poverty in affected areas.

When will we get more information from the trial and how can foundation colleagues support your work? 

We anticipate the trial will take approximately 5 years to complete, followed by a detailed statistical analysis of results prior to submission for regulatory approvals. We are grateful to our foundation partners for your ongoing support across our TB portfolio.