A Phase I, Randomized, Double-blind Study to Evaluate the Safety and Immunogenicity of rBCG30 Vaccine Administered Intradermally to Healthy Adults (R30-001)
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This was a Phase I, randomized (1:1), double-blind, 2-treatment group study to evaluate the safety and immunogenicity of rBCG30 vaccine administered on Study Day 0 by intradermal injection.
| Group | Dose Days | rBCG30: N (dose) | BCG Tice: N (dose) | Total: N |
|---|---|---|---|---|
| 1 | 0 | 18 (5 x 105 cfu) | 17 (5 x 105 cfu) | 35 |
Describe the safety and immunogenicity of 1 dose of rBCG30
A single dose of rBCG30 seemed to be more reactogenic than Tice BCG in healthy adults (higher rate of injection site pain & incidence of severe injection site reactions (erythema, pain, swelling))
St. Louis University (St. Louis, MO, US); Piedmont Medical Research Associates (Winston-Salem, NC, US)
TBD
Feb. 17, 2004
Nov. 30, 2004