NEW DELHI, Feb. 19, 2018 /PRNewswire-USNewswire/ -- Aeras, a nonprofit organization dedicated to developing vaccines against tuberculosis (TB), will highlight the progress being made in TB vaccine research at the 5th Global Forum on TB Vaccines in New Delhi, India, February 20-23, 2018. Presentations will include new data from Aeras's advancing portfolio of TB vaccines, including data from four clinical-stage candidates.

Ann Ginsberg, MD, PhD, Chief Medical Officer at Aeras and a member of the organizing committee for the 5th Global Forum on TB Vaccines, said: "We and our partners will share a range of new data at the 5th Global Forum on TB Vaccines, highlighting the scientific progress being made to develop potential new vaccines against TB, the world's leading cause of death from an infectious disease."

Over the past decade, more than a dozen new TB vaccine candidates have been tested in human clinical trials around the world. Serving as a critical translational bridge from the bench to the field, Aeras has sponsored and conducted over 55 clinical and epidemiological studies in 15 different countries. It has worked with partners to develop new approaches to R&D and new tools, such as the Controlled Human Infection Model. In addition, Aeras has contributed to preclinical research efforts by creating improved animal models of disease to facilitate and enhance initial screening for promising TB vaccine candidates.

First Data from Innovative Prevention-of-Infection Phase 2 Clinical Trial

Results will be presented for the first time from the Phase 2 prevention-of-infection clinical trial evaluating H4:IC31, a subunit vaccine candidate, and revaccination with Bacille Calmette-Guérin (BCG), the world's only commercially available TB vaccine. The study was conducted to evaluate the safety and immunogenicity of the vaccine regimens, as well as their ability to prevent initial and sustained TB infections among healthy adolescents in the Western Cape Province of South Africa.

Additional Clinical-Stage TB Vaccine Portfolio Data

Data will also be presented on other clinical-stage TB vaccines, including:

  • Data from a Phase 1/2a clinical trial evaluating the safety and immunogenicity of various dose regimens of H56:IC31 in HIV-negative adults with and without latent TB infection.
  • Follow-up data from a Phase 1 clinical study, evaluating the ability of the GLA-SE adjuvant to improve the magnitude and quality of immune response to the ID93 vaccine. This study was the first in which the ID93 vaccine was tested in humans.
  • Data from a Phase 1b trial evaluating different doses of the ID93+GLA-SE vaccine for use in TB endemic countries.
  • Learnings associated with the impact of implementing an effective community engagement strategy on retention rates in a Phase 2b prevention-of-disease study for the M72 vaccine in South Africa, Zambia and Kenya.

Note to Editors

A full list of abstracts associated with research conducted and/or funded by Aeras to be presented at the 5th Global Forum on TB Vaccines is as follows:

(Note: All 5th Global Forum presentations and posters will take place within the Taj Diplomatic Enclave Hotel (formerly Taj Palace), located at 2 Sardar Patel Marg, Diplomatic Enclave, New Delhi. The times provided are in India Standard Time.)

Abstract #

Title

Presentation Details

PS-05

Enriching cohorts for smaller, quicker, more

efficient TB vaccine efficacy trials

Plenary Session 1: Increasing

Probability of Success and

Maximizing Impact

Time: 14:00 – 16:00, February 20

Location: Shahjehan

PD-08

Demonstration of a correlation between the in

vitro direct mycobacterial growth inhibition

assay (MGIA) and protection from in vivo

mycobacterial challenge

Poster Discussion 1: Basic Vaccine

Concepts and Correlates of

Protective Immunity

Time 16:15 – 17:45, February 20

Location: Roshanara

PD-24

The ESAT-6 free IGRA, a companion diagnostic

for ESAT-6 based TB vaccines

Poster Discussion 2: Diagnostics

and Epidemiology

Time: 16:15 – 17:45, February 20

Location: Sheesh Mahal

PD-28

Optimization and interpretation of serial

QuantiFERON testing to measure acquisition of 

M. tuberculosis infection

PA-10

Synthetic Polysaccharide Conjugate Vaccines

Expressing Mycobacterium tuberculosis Antigens

Induce High-titer Antibody Responses in Mice,

Guinea Pigs, and Rabbits

Poster Viewing: Novel Vaccine

Concepts, Chemistry,

Manufacturing and Controls

Time: 16:15 – 17:45, February 20

Location: Mumtaz Mahal

PA-16

Comparison of pellicle and liquid grown BCG

reference strains in standard BCG batch release

assays and protection studies

PS-06

Prevention of infection with Mycobacterium

tuberculosis by H4:IC31 vaccination or BCG

revaccination n healthy adolescents: results of a

randomized controlled trial

Plenary Session 2: Clinical

Development of New TB Vaccines

Time: 9:00 – 11:00, February 21

Location: Shahjehan

PS-10

A critical juncture in tuberculosis vaccine clinical

development: overview of progress

PS-07

Community engagement and Good Participatory

Practice Guidelines for TB vaccine research and

development

OA-09

Clinical development of ID93+GLA-SE as a

prophylactic or therapeutic vaccine for

tuberculosis

Breakout Presentation 2: Clinical

Research

Time: 11:30 – 13:30, February 21

Location: Jejangir

PS-11

The route of BCG vaccination determines

 immunity and protection against

Mycobacterium tuberculosis infection in non-

human primates

Plenary Session 3: Novel

Approaches to TB Vaccine

Research & Development

Time: 14:00 – 16:00, February 21

Location: Shahjehan

PS-12

Vaccination following mycobacterial exposure

PD-15

T cell immunity in the lung and protection

following aerosol, intravenous, or intradermal

administration of BCG in nonhuman primates

Poster Discussion 3: Preclinical

Research

Time: 16:30 – 18:00, February 21

Location: Roshanara

PD-14

Animal dose response curve predicts lower

optimal tuberculosis vaccine dose in humans:

The use of vaccine Immunostimulation/

Immunodynamic modelling methods to inform

vaccine dose decision-making

PD-34

Immunogenicity of AERAS-404 or BCG

revaccination in a prevention of established M.

tuberculosis infection efficacy trial

Poster Discussion 4: Clinical

Research and Community

Engagement

Time: 16:30 – 18:00, February 21

Location: Sheesh Mahal

PD-38

Safety and immunogenicity of H56:IC31 in HIV-

negative adults with and without latent

tuberculosis (TB) infection

PD-37

The Toll-like Receptor 4 agonist adjuvant, GLA-

SE, improves magnitude and quality of immune

responses elicited by the ID93 tuberculosis vaccine

PD-36

Dose definition of the novel TB vaccine

ID93+GLA-SE for TB endemic countries

PD-39

Impact of implementing an effective community

engagement strategy on retention rates in a

Phase 2b Prevention of Disease TB vaccine trial

in South Africa, Zambia, and Kenya

OA-16

Immunogenicity and efficacy evaluation of

prime-boost vaccine regimens with ChAd3-4Ag

+/- MVA5Ag in rhesus macaques

Breakout Session 3: Novel Vaccine

Concepts and Preclinical Research

Time: 11:30 – 13:00, February 22

Location: Shahjehan

OA-21

Evaluating immune correlates of risk of

Mycobacteria tuberculosis infection in humans

Breakout Session 4: Biomarkers,

Correlates and Epidemiology

Time: 11:30 – 13:00, February 22

Location: Jehangir

 

About Aeras

Aeras is a nonprofit organization advancing the development of new tuberculosis vaccines for the world in partnership with other biotech, pharmaceutical and academic organizations. Aeras is primarily funded by The Bill & Melinda Gates Foundation, the UK Department for International Development (DFID), and other parties committed to ending the TB epidemic. Aeras also receives support from the U.S. government and through partnerships and collaborations with universities and pharmaceutical companies around the world. Aeras is headquartered in Rockville, Maryland (USA), with a clinical development and operations office in Cape Town, South Africa. For more information, please visit www.aeras.org.

Aeras is a lead organizing partner of the 5th Global Forum on TB Vaccines.

For more information, contact:
Jennie Willson at jwillson@aeras.org  or +1 301-547-2840

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