Last reviewed 2026-04-23 · How we verify

AERAS-404

AERAS-404 is a vaccine designed to protect against tuberculosis.

AERAS-404 is a vaccine designed to protect against tuberculosis. Used for Tuberculosis.

At a glance

Mechanism of action

AERAS-404 is a novel vaccine candidate that aims to provide long-term protection against tuberculosis by stimulating the immune system to recognize and respond to the bacteria that cause the disease. The vaccine has been engineered to express a specific protein from the Mycobacterium tuberculosis bacteria, which triggers an immune response that can help prevent infection.

Approved indications

• Tuberculosis

Common side effects

• Injection site pain

Key clinical trials

• Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (PHASE2)
• Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants (PHASE1, PHASE2)
• A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults (PHASE1)
• A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 (C-011-404) (PHASE1)
• A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults (PHASE1)
• A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection (PHASE1)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• AERAS-404 CI brief — competitive landscape report
• AERAS-404 updates RSS · CI watch RSS
• Aeras portfolio CI