NCT01861730 - Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants | Biotech Hunter

Enrollment

243

Participants

Timeline

Start Date

July 1, 2013

Primary Completion Date

December 22, 2017

Study Completion Date

December 22, 2017

Conditions

Tuberculosis

Interventions

BIOLOGICAL

AERAS-404

AERAS-404 has two components: the H4 antigen and the IC31 adjuvant. The reconstitution of the vaccine components, H4 antigen (manufactured at SP) and IC31 adjuvant (supplied by SSI), will take place at the clinical research site (CRS) prior to injection.

BIOLOGICAL

Placebo

Tris buffered saline (10mM Tris, pH 7.4, 150nm sodium chloride).

Trial Locations (4)

2001

Shandukani Research, Johannesburg

2091

PHRU, Chris Hani Baragwanath Hospital, Johannesburg

7505

KID-CRU, Tygerberg Hospital, Cape Town

Unknown

South African TB Vaccine Initiative (SATVI), Worcester