Phase 1 Study in Malaria Naïve Adults of BSAM2/Alhydrogel®+CPG 7909, a Blood Stage Vaccine against P. falciparum Malaria

Ruth D. Ellis, Yimin Wu, Laura B. Martin, Donna Shaffer, Kazutoyo Miura, Joan Aebig, Andrew Orcutt, Kelly Rausch, Daming Zhu, Anders Mogensen, Michael P. Fay, David L. Narum, Carole Long, Louis Miller, Anna P. Durbin

Research output: Contribution to journalArticle

Abstract

A Phase 1 dose escalating study was conducted in malaria naïve adults to assess the safety, reactogenicity, and immunogenicity of the blood stage malaria vaccine BSAM2/Alhydrogel®+ CPG 7909. BSAM2 is a combination of the FVO and 3D7 alleles of recombinant AMA1 and MSP142, with equal amounts by weight of each of the four proteins mixed, bound to Alhydrogel®, and administered with the adjuvant CPG 7909. Thirty (30) volunteers were enrolled in two dose groups, with 15 volunteers receiving up to three doses of 40 μg total protein at Days 0, 56, and 180, and 15 volunteers receiving up to three doses of 160 μg protein on the same schedule. Most related adverse events were mild or moderate, but 4 volunteers experienced severe systemic reactions and two were withdrawn from vaccinations due to adverse events. Geometric mean antibody levels after two vaccinations with the high dose formulation were 136 μg/ml for AMA1 and 78 μg/ml for MSP142. Antibody responses were not significantly different in the high dose versus low dose groups and did not further increase after third vaccination. In vitro growth inhibition was demonstrated and was closely correlated with anti-AMA1 antibody responses. A Phase 1b trial in malaria-exposed adults is being conducted. Trial Registration: Clinicaltrials.gov NCT00889616.

Original languageEnglish (US)
Article numbere46094
JournalPloS one
Volume7
Issue number10
DOIs
StatePublished - Oct 4 2012

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)
  • General

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    Ellis, R. D., Wu, Y., Martin, L. B., Shaffer, D., Miura, K., Aebig, J., Orcutt, A., Rausch, K., Zhu, D., Mogensen, A., Fay, M. P., Narum, D. L., Long, C., Miller, L., & Durbin, A. P. (2012). Phase 1 Study in Malaria Naïve Adults of BSAM2/Alhydrogel®+CPG 7909, a Blood Stage Vaccine against P. falciparum Malaria. PloS one, 7(10), [e46094]. https://doi.org/10.1371/journal.pone.0046094