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Related Experiment Video

Updated: Nov 1, 2025

Expression of Exogenous Antigens in the Mycobacterium bovis BCG Vaccine via Non-genetic Surface Decoration with the Avidin-biotin System
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A 2-Dose AERAS-402 Regimen Boosts CD8+ Polyfunctionality in HIV-Negative, BCG-Vaccinated Recipients.

Dhanasekaran Sivakumaran1,2, Gretta Blatner3,4, Rasmus Bakken1,2

  • 1Department of Clinical Science, Bergen Integrated Diagnostic Stewardship Cluster, Faculty of Medicine, University of Bergen, Bergen, Norway.

Frontiers in Immunology
|June 28, 2021
PubMed
Summary
This summary is machine-generated.

A new tuberculosis (TB) vaccine, AERAS-402, showed good safety and boosted immune responses in healthy Indian adults. This Ad35-based vaccine induced polyfunctional CD8+ T cells, offering hope for improved TB prevention strategies.

Keywords:
tuberculosisAERAS-402Phase 1 trialT-cell responsesTB vaccinetranscriptional profiling

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Area of Science:

  • Immunology
  • Vaccinology
  • Infectious Diseases

Background:

  • Tuberculosis (TB) remains a significant global health challenge, with current vaccines like BCG offering insufficient long-term protection.
  • New vaccine candidates are crucial to combat the persistent threat of TB worldwide.

Purpose of the Study:

  • To evaluate the safety and immunogenicity of AERAS-402, a novel Ad35-vectored TB vaccine, in a TB-endemic region.
  • To assess immune responses, including T-cell function and gene expression, following vaccination with AERAS-402.

Main Methods:

  • Phase I clinical trial involving 12 healthy male participants in India, randomized to receive AERAS-402 or placebo.
  • Administration of two intramuscular doses of the vaccine or placebo.
  • Assessment of safety, CD4+ and CD8+ T-cell responses via intracellular cytokine staining (ICS), and transcriptional profiling using dc-RT MLPA.

Main Results:

  • AERAS-402 was well-tolerated with no vaccine-related serious adverse events.
  • The vaccine induced robust, polyfunctional CD8+ T-cell responses (co-expressing IFN-γ, TNF-α, IL-2) and notable CD4+ T-cell responses.
  • Differential gene expression in PBMCs indicated vaccine-induced immune activation, with specific genes like CXCL10 and IFI35 showing altered expression.

Conclusions:

  • AERAS-402 demonstrated a favorable safety profile in healthy Indian adults.
  • The vaccine effectively stimulated predominantly polyfunctional CD8+ T cells and altered gene expression, suggesting potential for TB prevention.