Vaccine Candidates

Aeras and our global research and development partners play an integral role in developing approximately half of all TB vaccine candidates in clinical development around the world. Once a preclinical candidate shows acceptable safety and promising immunological data in animal studies, the approval process to begin human trials is initiated.

Clinical Portfolio

  • M72 + AS01E
  • H4/AERAS-404 + IC31
  • ID93 + GLA-SE
  • H56/ AERAS-456 + IC31
  • DAR-901

M72 + AS01E

M72 + AS01E

The M72 + AS01E vaccine candidate is being developed by GlaxoSmithKline, a leading global healthcare company. 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.

  • In preclinical settings, M72 formulated with AS01E has proven effective for mobilizing immune cells and effectors that are believed to play a key role in protecting against tuberculosis.
  • This candidate is unique insofar as the M72 fusion protein combined with the AS01E adjuvant system induces high levels of M72 specific CD4+ T cells in humans.
  • M72 is intended for manufacture on a scale required to meet the needs of those who need it most.
  • This vaccine is being developed for use in TB-endemic countries.

Development Status

GSK and Aeras have collaborated on several studies of formulations of this candidate.

A Phase IIB trial to evaluate M72 + AS01E in adults is currently enrolling.

What the experts are saying:

"There is a need for new vaccines to protect against pulmonary TB in adolescents and adults. GSK, in partnership with Aeras, is committed to research aimed at developing a vaccine that meets this need.”
Dr. Didier Lapierre
Vice President of Clinical Development
"A vaccine that prevents adolescents and adults from developing infectious TB would be the single greatest advance in the fight against the disease."
Dr. Videlis Nduba
Principal Investigator

Trials with Aeras

Development Phase Study Population Location Field Site Partner Trial Sponsor Study Status
Phase II Adults South Africa, Kenya, Zambia GSK Investigational Sites GlaxoSmithKline Ongoing
Phase II Adults Belgium Universitair Ziekenhuis, Gent-Gent GlaxoSmithKline Ongoing
Phase I Adults, PPD negative USA Cornell (New York Presbyterian Hospital) - New York GlaxoSmithKline Completed
Phase I Adults, PPD negative Belgium Universitair Ziekenhuis, Gent-Gent GlaxoSmithKline Completed
Phase I/II Adults, PPD positive (BCG cohort and infected cohort) Switzerland Centre Hospitalier, Universitaire Vaudois (CHUV) - Lausanne GlaxoSmithKline Completed
Phase I/II Adults, PPD negative Belgium Universitair Ziekenhuis, Gent-Gent GlaxoSmithKline Completed
Phase I/II Adults, HIV positive - infection controlled Switzerland Centre Hospitalier, Universitaire Vaudois - Lausanne GlaxoSmithKline Completed
Phase II Adults, PPD negative and PPD positive South Africa SATVI GlaxoSmithKline Completed
Phase II Adolescents, BCG vaccinated South Africa SATVI GlaxoSmithKline Completed
Phase II Adults, PPD positive Philippines City Health Office I - Santa Rosa City GlaxoSmithKline Completed
Phase II Infants, BCG vaccinated The Gambia Medical Research Council GlaxoSmithKline Completed

H4/AERAS-404 + IC31

H4/AERAS-404 + IC31

H4/AERAS-404 + IC31® uses SSI's H4 antigen (a fusion protein of M. tuberculosis antigens 85B and TB10.4), combined with the biotech company Valneva's IC31® adjuvant to stimulate T cell-mediated immunity. This candidate vaccine has induced more protection in a BCG prime-boost regimen than any other vaccine tested in the long-term guinea pig challenge model.

  • The Statens Serum Institut (SSI) in Denmark, one of the leading TB vaccine development organizations in the world, discovered key antigens and developed a number of key technologies that are important to the development and production of a new TB vaccine.
  • In 2005, Aeras entered into a development partnership with SSI for H4-IC31®. In 2008, SSI partnered with Sanofi Pasteur in Canada to further develop this promising candidate, the clinical trials of which are currently being conducted by Aeras.
  • An earlier version of this vaccine with the same adjuvant but utilizing antigen ESAT-6 instead of TB10.4 was shown to be safe and immunogenic in Phase I human trials.
  • H4/AERAS-404 + IC31 is being developed to augment the immunity induced by a previous BCG vaccination.

Development Status

H4/AERAS-404 + IC31® has completed four Phase I trials in Europe and South Africa. A Phase II trial to study prevention of infection in adolescents and adults, as well as BCG revaccination, started in South Africa in March 2014.

What the experts are saying:

“TB is a major and global public-health burden; we are committed to developing a new vaccine to prevent this infectious disease. We look forward to working with our partners, AERAS and others with the same goal."
Dr. Sanjay Gurunathan
Associate VP for Clinical Development at Sanofi Pasteur
"Nearly 100 years after the discovery of the first TB vaccine we still deal with TB disease and death on a daily basis. Concerted efforts through partnerships are more likely to have high impact, be successful and benefit our communities."
Dr. Avy Violari
Principal Investigator

Trials with Aeras

Development Phase Study Population Location Field Site Partner Trial Sponsor Study Status
Phase I/II Infants BCG Vaccinated South Africa Statens Serum Institut (SSI), Sanofi Pasteur (SP), National Institute of Allergy and Infectious Diseases (NIAID) - International Maternal Pediatric Adolescents AIDS Clinical Trial Group (IMPAACT), The Eunice Kennedy Shriver National Institute of Child Health and Human Development 9NICHD Aeras Ongoing
Phase II Adults & Adolescents BCG Vaccinated South Africa SATVI Aeras Ongoing
Phase I Adults BCG Unvaccinated Switzerland Le Centre Hospitalier Universitaire Vaudois (CHUV) Aeras Completed
Phase I Adults BCG Vaccinated Sweden Karolinska Institutet Aeras Completed
Phase I Adults BCG Vaccinated South Africa SATVI, UCT Aeras Completed
Phase II Adults BCG Vaccinated Finland University of Tampere Aeras Completed

ID93 + GLA-SE

ID93 + GLA-SE

  • ID93 + GLA-SE, designed by the Infectious Disease Research Institute (IDRI) in Seattle, is composed of a recombinant fusion-protein of four M. tuberculosis antigens (Rv2608, Rv3619, Rv3620, and Rv1813), plus IDRI’s proprietary adjuvant, GLA-SE. This adjuvant has been previously tested in humans but has not been used in any other TB vaccine currently in clinical development.
  • ID93 + GLA-SE targets both active and latent TB that lies dormant in one third of the world’s population and reactivates when their immune systems are compromised..

Development Status

A Phase 2a trial of ID93 + GLA-SE is currently in progress and is designed to assess safety and immunogenicity. A Phase 2b prevention of infection study is in planning.

What the experts are saying:

“Tuberculosis is one of the most widespread, persistent and deadly global health problems…we believe this collaboration will speed the development of this promising new vaccine.”
Dr. Steven Reed
Founder, President and Chief Scientific Officer at IDRI

Trials with Aeras

Development Phase Study Population Location Field Site Partner Trial Sponsor Study Status
Phase II Adults South Africa Wellcome Trust South African Tuberculosis Vaccine Initiative (SATVI) IDRI Ongoing
Phase I Adults BCG vaccinated USA Johnson County ClinTrials Infectious Disease Research Institute Completed
Phase I Adults BCG vaccinated South Africa South African Tuberculosis Vaccine Initiative (SATVI) Infectious Disease Research Institute Completed

H56/ AERAS-456 + IC31

H56/ AERAS-456 + IC31

The candidate TB vaccine H56/AERAS-456 + IC31 is a subunit vaccine containing a fusion protein of three M. tuberculosis antigens (85B, ESAT-6 and Rv2660c) formulated in the proprietary adjuvant IC31® from Intercell.

  • H56/AERAS-456 + IC31 is being developed for both adolescent and adult populations.
  • This vaccine was first developed by a consortium of researchers, led by Peter Anderson at the Statens Serum Institut (SSI) in Denmark with support from the Grand Challenges in Global Health, an initiative fostering scientific breakthroughs needed to prevent, treat and cure diseases of the developing world.
  • H56/AERAS-456 + IC31 is being developed to augment the immunity induced by a previous M. tuberculosis infection.

Development Status

This candidate is being tested in a Phase I trial in Worcester in the Western Cape province of South Africa, the first time a South African research institute has led a first-in-human Phase I clinical trial of a new TB vaccine, and a Phase I/IIa study in HIV-negative adults with and without latent TB infection. A Phase 2 prevention of infection study is in planning.

What the experts are saying:

“The development of urgently needed new TB vaccines requires a global effort.”
Dr. Peter Andersen
VP of Vaccine Research and Development at Statens Serum Institut (SSI)
“Let’s think out of the box for new tools and weapons to win the war against Mycobacterium tuberculosis. This goal can be reachable with everyone’s contribution.”
Dr. Angelique Luabeya
Principal Investigator, research officer at South African Tuberculosis Vaccine Initiative (SATVI)

Trials with Aeras

Development Phase Study Population Location Field Site Partner Trial Sponsor Study Status
Phase I Adults Recently treated for pulmonary TB South Africa SSI Aeras Ongoing
Phase I/IIa Adults HIV-negative with and without latent TB infection South Africa SSI Aeras Ongoing

DAR-901

DAR-901

DAR-901 is a killed whole cell vaccine developed by researchers at Dartmouth's Geisel School of Medicine. DAR-901 is being evaluated as a booster vaccine for adolescents and adults throughout the world who received the existing and widely used Bacille Calmette-Guérin (BCG) TB vaccine as infants or young children. The vaccine, known as DAR-901, is related to the vaccine SRL-172, previously shown by Dartmouth investigators to decrease the risk of TB in a trial known as the DarDar Trial.

Development Status

Aeras developed a scalable method for manufacturing for the vaccine and is supporting the first-in-human clinical trial to test DAR-901’s safety. The Phase I study is sponsored by Dartmouth and will be initiated in the first half of 2014.

What the experts are saying:

"Our goal is to demonstrate that this is an effective booster vaccine that could help reduce the burden of TB disease throughout the world.”
Ford von Reyn
Professor of Medicine, Dartmouth’s Geisel School of Medicine

Trials with Aeras

Development Phase Study Population Location Field Site Partner Trial Sponsor Study Status
Phase I Adults US Dartmouth-Hitchcock Medical Center Dartmouth-Hitchcock Medical Center Ongoing

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.