Phase II double-blind, randomised, placebo-controlled study the safety and immunogenicity of H1/IC31 (trademarked), in HIV-infected adults without TB

Phase II double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of H1/IC31 (trademarked), an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells per mm cubed

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201105000289276

Enrollment

Registered

2011-04-15

Start date

2012-01-10

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Tuberculosis

Interventions

Study Vaccine H1/IC31

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. TB negative 2. HIV infected 3. CD4 count greater than 350 cells per ml cubed

Exclusion criteria

Exclusion criteria: Evidence of or suspected active TB

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults;To evaluate the induction of cellular and humoral immunity of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults	—

Secondary

Measure	Time frame
To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on CD4+ lymphocyte counts;To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on HIV viral loads	—

Countries

South Africa

Contacts

Public ContactGavin Churchyard

Responsible Contact Person (public)

gchurhyard@auruminstitute.org010 590 1300

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026