Tuberculosis vaccine candidate enters phase-2-trial

In the clinical trial HIV-exposed newborn infants are vaccinated with VPM1002

July 10, 2015
Enrollment of the first infant in a phase-2-clinical trial of a new vaccine to prevent tuberculosis has successfully started. VPM1002, the most advanced new tuberculosis vaccine in clinical development, will help curtail spread of life-threatening tuberculosis disease not only in endemic countries, but also in Europe. The new vaccine VPM1002 was co-developed by scientists from the Max Planck Society and Hannover-based VPM, a spin-off company from the Helmholtz Centre for Infection Research.

The vaccine candidate VPM1002 was recently out-licensed to Serum Institute of India Ltd., the world’s largest vaccine manufacturer according to number of doses sold. VPM1002 is developed by SIIL in collaboration with Vakzine Projekt Management GmbH (VPM). Adar C. Poonawalla, CEO and Executive Director of Serum Institute of India emphasizes that “Tuberculosis still remains a major public health problem and only a new and more effective vaccine can help to restrict the expansion of multidrug-resistant and extremely drug-resistant tuberculosis and thus save the lives of millions of people each year. We are pleased with the start of this trial as it represents one more step in our efforts to continuously improve existing vaccines, and to make new, safe, efficacious and cost effective vaccines available to the world, especially for tuberculosis. This is also shown in our plans to start large trials with VPM1002 to address the challenges of relapsing tuberculosis in adults.”

Stefan H. E. Kaufmann, the Founding Director of the Max Planck Institute for Infection Biology, who was largely responsible for the scientific concept of VPM1002, adds: “The former BCG vaccine continues to be the most commonly administered vaccine. Although it can protect against certain forms of tuberculosis, its protective efficacy is insufficient and alarmingly, potential BCG-related adverse events in HIV-positive newborns frequently occur. BCG also poses a high risk for any infant born with congenital genetic immunodeficiency.” And he continues saying that the goal with VPM1002 is “to sharpen BCG’s blade, and make it safer and more efficacious for successful combat of tuberculosis.”

VPM1002 was modeled on an earlier tuberculosis vaccine called BCG – short for Bacillus Calmette–Guérin – that was first introduced in 1921, and since then has been given to millions of infants each year where tuberculosis is prevalent. What makes VPM1002 unique when compared with BCG is the fact that targeted genetic modifications make the vaccine much safer and more effective in preventing tuberculosis. A series of studies in animal models, and two separate phase-1-clinical trials in adults and one phase-2a-clinical trial in newborn infants, have already confirmed safety and have shown sufficient strengthening of the immune system against tuberculosis, thus raising hope for higher efficacy.

“Already during the phase-1-clinical trials in Europe and Africa, the new vaccine showed better tolerance and triggered a more targeted immune response than classical BCG. These promising findings were confirmed in a subsequent phase-2a-trial in newborns, our ultimate target group,” confirms Bernd Eisele, VPM’s CEO. “And now, enrolling the first infant in the current phase-2-clinical trial in HIV-exposed infants, that is, infants who need a safer and better vaccine the most, is a huge success. It brings us one important step closer to including the new vaccine in a global plan of action against tuberculosis by the end of this decade.”

The phase-2-clinical trial currently taking place in South Africa, a tuberculosis hotbed, commenced this June and is the first investigation of the vaccine in HIV-exposed infants. Especially HIV-exposed infants may suffer from severe adverse events after vaccination with the common BCG and therefore are in urgent need of a safer and more effective vaccine. According to the clinical trial’s principal investigators, Mark Cotton and Anneke Hesseling of Stellenbosch University and Desmond Tutu Tuberculosis Center, Angelique Luabeya from the South African Tuberculosis Vaccine Initiative and Shabir Madhi of the Respiratory and Meningeal Pathogens Research Unit, “this trial with VPM1002 is an important milestone in our global fight against tuberculosisdeadly threat – the disease currently afflicts about two billion people.”

Leander Grode, Kaufmann’s former research fellow and co-inventor, who has since become Chief Scientific Officer at VPM, contributed substantially to VPM1002’s development. “We have successfully modified the original vaccine in such a way that it is now better at activating the human immune system, thereby affording more protection and safeguarding against the tuberculosis pathogen,” Grode explains.



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