Ag85B–ESAT-6 adjuvanted with IC31® promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naïve human volunteers

Vaccine against tuberculosis: what’s new?

“…No serious adverse events related to the vaccine have been reported. Local and systemic described events were mild and quickly resolving (<48 hours) [45,50,51]. …”

“…The immune response can be amplified by booster vaccinations. H1/IC31 induce a weak immune response against ESAT6; however this vaccine provided a more potent protective effect than a vaccine with Ag85B alone [45,50,51]. …”

“…Even if H1/IC31 has shown to induce QuantiFERON positivity in only few subjects, further studies evaluating possible interference of the vaccine with IGRA results are needed [45,50,51]. …”

Multiantigenic subunitary vaccines against tuberculosis in clinical trials: Where do we stand and where do we need to go?

“…14 In 2010, the safety and tolerability of the fusion vaccine candidate termed H1 (combination of ESAT-6 C Ag85B C adjuvant IC31) was demonstrated in a Phase I clinical trial. 15 Ag85B in combination with another antigen, TB 10.4, plus IC31, was recently shown to have an acceptable safety profile and was immunogenic in South African adults, 16 and testing different amounts of vaccine allowed to find that producing a more robust immune response.…”

A high ratio of IC31®adjuvant to antigen is necessary for H4 TB vaccine immunomodulation

“…10,11 Recent work in mice suggests protective immunity induced by H4-IC31 is highly sensitive to antigen dose, 12 while a clinical response to a similar vaccine was directly influenced by the adjuvant dose. 13 Understanding the functional relationship between the adjuvant and antigen is critical to define vaccine formulations. Despite the need to understand vaccine-induced immune responses, tools available to assess biological functionality are limited.…”