AIDSWEEKLY Plus, Monday, 3 November 1997
Daniel J. DeNoon, Senior Editor
A new mucosal vaccine adjuvant designed for use with killed pathogens proved safe in humans.
Tolerable dosages of the adjuvant, dubbed LT[R192G], were well within the range expected to be used in combination with vaccine immunogens.
"This study demonstrated that LTR192G adjuvant can be safely given to adults at potentially adjuvant-active doses," said Michael Oplinger of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, Maryland.
LT[R192G] is a form of Escherichia coli heat-labile enterotoxin that has been genetically engineered to have extremely reduced toxicity but the same immunogenicity of the wild-type toxin.
Oplinger et al. enrolled 36 adults in a dose escalation study in which the volunteers received a single oral dose of LT[R192G] (at 5, 25, 50, or 100 mg) or placebo.
"LTR192G was shown to be safe at doses +/-50 mg with no volunteers reporting any loose stools," Oplinger reported. "Two of 12 (16.7 percent) volunteers receiving the highest dose (100 mg) developed mild-to-moderate diarrhea that resolved within 24 hours."
Statistical analysis revealed a trend toward increased symptoms with increased doses, but no statistically significant association between symptoms and doses of less than 100 mg.
As measured by LTB-specific antibody-secreting cells and serum IgA/IgG responses to LTB, LT[R192G] was immunogenic at all doses with no increase in immunogenicity seen at doses greater than 25 mg, the most effective dose.
"A safe and effective mucosal adjuvant could greatly improve protection from killed vaccines, making them ideal for national and global immunization programs," Oplinger suggested.
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