QS-21 promotes an adjuvant effect allowing for reduced antigen dose during HIV-1 envelope subunit immunization in humans.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

Three separate studies were undertaken in HIV-1 uninfected persons to determine if the adjuvant QS-21 improves the magnitude or kinetics of immune responses induced by recombinant soluble gp120 HIV-1(MN) protein (rsgp120) immunization. The QS-21 was administered at two doses (50 and 100 microg), either alone or in combination with aluminum hydroxide (600 microg). At the highest doses of rsgp120 (100, 300, and 600 microg), QS-21 exerted no significant effect on either binding or neutralizing antibody titers. Antibody binding and neutralizing responses fell dramatically when rsgp120, formulated with alum alone, was given at low doses (3 and 30 microg). In contrast, antibody responses similar in titer to those in the high dose antigen groups were induced with the low dose rsgp120 formulated with QS-21. In addition, the lymphocyte proliferation and delayed type hypersensitivity skin testing were superior in the QS-21 recipients compared with the alum recipients at the low antigen doses. Moderate to severe pain was observed in majority of the volunteers receiving QS-21 formulations, and vasovagal episodes and hypertension were not infrequent. Thus, the use of QS-21 may provide a means to reduce the dose of a soluble protein immunogen.

Full Text

Duke Authors

Cited Authors

  • Evans, TG; McElrath, MJ; Matthews, T; Montefiori, D; Weinhold, K; Wolff, M; Keefer, MC; Kallas, EG; Corey, L; Gorse, GJ; Belshe, R; Graham, BS; Spearman, PW; Schwartz, D; Mulligan, MJ; Goepfert, P; Fast, P; Berman, P; Powell, M; Francis, D; NIAID AIDS Vaccine Evaluation Group,

Published Date

  • February 28, 2001

Published In

Volume / Issue

  • 19 / 15-16

Start / End Page

  • 2080 - 2091

PubMed ID

  • 11228380

International Standard Serial Number (ISSN)

  • 0264-410X

Digital Object Identifier (DOI)

  • 10.1016/s0264-410x(00)00415-1


  • eng

Conference Location

  • Netherlands