Vaccine Candidates

Clinical Portfolio

  • M72 + AS01E
  • H4:IC31
  • H56:IC31
  • MTB-VAC

M72 + AS01E

M72 + AS01E

The M72/AS01E vaccine candidate is being developed by GlaxoSmithKline, a leading global healthcare company in partnership with Aeras. The vaccine comprises an immunogenic fusion protein (M72) derived from two M. tuberculosis antigens (MTB32A and MTB39A), identified in human and animal studies over a 20-year period, and the GSK proprietary adjuvant AS01E. This candidate is unique insofar as the M72 fusion protein combined with the AS01E adjuvant induces high levels of M72 specific CD4+ T cells in humans.

Development Status

GSK and Aeras have collaborated on multiple clinical trials of this candidate. We expect results from a Phase 2b efficacy study (TB-018) of 3573 adults in three countries in Africa (South Africa, Zambia, Kenya) in 2018. 

H4:IC31

H4:IC31

H4:IC31 is an investigative subunit vaccine candidate being developed jointly by Aeras and Sanofi Pasteur, in collaboration with the Statens Serum Institut. H4:IC31 is comprised of the H4 antigen (a recombinant fusion protein of Mtb antigens 85B and TB10.4), combined with the biotech company Valneva's IC31® adjuvant to stimulate T cell-mediated immunity. The vaccine candidate has been shown to be immunogenic and protective before and after Mtb exposure in preclinical animal models. This vaccine candidate is being developed for use in adolescents and young adults who have received BCG immunization in the past (most likely as infants).

Development Status

  • We expect results from a Phase 2, Pre-Proof of Concept, Prevention of Infection trial in 990 adolescents in South Africa in early 2018.
  • A Phase 1/2a safety, immunogenicity and dose and regimen finding study (C-015-404) of 229 infants in South Africa who were recently vaccinated with BCG is currently in follow up. Final results are expected in 2018.
  • A Phase 1b safety and immunogenicity study (A-042) of 84 adolescents in South Africa has been completed. Final data expected in 2018.

H56:IC31

H56:IC31

H56:IC31 is a subunit vaccine candidate containing a fusion protein of three M. tuberculosis antigens (85B, ESAT-6 and Rv2660c) formulated in the proprietary adjuvant IC31® from Valneva. This vaccine was first developed by a consortium of researchers led by Peter Andersen at the Statens Serum Institut (SSI) in Denmark with support from the Grand Challenges in Global Health. H56:IC31 is being developed in partnership with Aeras for prevention of TB in both adolescent and adult populations, regardless of QFN status.

Development Status

  • A Phase 2 Prevention of Infection trial (A-043) is scheduled to launch in 2018. Funders and collaborators include Globvac, Wellcome Trust, EDCTP, DFID and SSI.
  • A Phase 2 Prevention of Reoccurrence Trial is scheduled to launch in 2018. The trial is funded by EDCTP and in collaboration with SSI.

MTB-VAC

MTB-VAC

MTBVAC is the first and only live attenuated vaccine based on a human isolate of M. tuberculosis. It was designed and constructed by the research groups at the University of Zaragoza and the Brigitte Gicquel of Institut Pasteur in Paris. 

Development Status

Aeras and partners are preparing to launch a Phase 2a study (A-050) in adults in South Africa in 2018.  

Pre Clinical Candidates

Our preclinical research is designed to advance vaccine development with novel technologies by actively seeking and supporting new approaches and delivery systems to ensure a robust R&D pipeline, with new candidates being developed to fill gaps in the portfolio.

We are conducting a wide range of proof of concept studies in a variety of accepted experimental model systems to ensure there is robust evidence of efficacy and safety data to support advancement to clinical development.

Pre Clinical Portfolio

  • ChAd63
  • PIV
  • MVA
  • rCMV

ChAd63

ChAd63

ChAd63 is a simian adenovirus serotype 63 viral vector platform for delivery of antigens. Viral vectored vaccines show considerable promise as vaccine candidates due to their ease of generation, often low-cost manufacture, and ability to induce significant cellular immunity.

In partnership with Okairos, a biopharmaceutical company based in Italy, a range of specific ChAd63-based viral vector delivery platforms have been generated and are currently being studied for immunogenicity and efficacy.

PIV

PIV

Human parainfluenza virus (PIV) is a viral vector antigen delivery platform that is replication deficient and has shown good antigen delivery capabilities with a good safety profile.

MVA

MVA

Modified Vaccinia Ankara (MVA) is a replication deficient viral vector antigen delivery platform with an extensive and safe clinical history. This platform has been effective in antigen delivery of a wide range of TB antigens. Despite results of a Phase IIb safety and efficacy clinical trial of a vaccine based on an MVA platform that showed the investigational vaccine (MVA85A) to be safe but not efficacious against TB disease, further investigation is warranted.

rCMV

rCMV

Recombinant cytomegalovirus (rCMV) is a viral vector-based vaccine platform for delivery of antigens. It is a potent inducer of long-term effector memory T-cells and, of particular interest in relation to TB, induces antigen specific pulmonary T cells. The research is currently being led by Louis Picker of Oregon Health and Science University (OHSU).

As with all vaccines using viral vectors, careful attention will be paid towards engineering the rCMV vector in a way that addresses safety concerns while maximizing the vaccine’s protective potential.