Homologous boosting with adenoviral serotype 5 HIV Vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial

Uzma N. Sarwar, Laura Novik, Mary E. Enama, Sarah A. Plummer, Richard A. Koup, Martha C. Nason, Robert T. Bailer, Adrian B. McDermott, Mario Roederer, John R. Mascola, Julie E. Ledgerwood, Barney S. Graham, Elizabeth Adams, Nina Berkowitz, Joseph Casazza, Pamela Costner, Ingelise Gordon, Cynthia Starr Hendel, Lasonji Holman, Brenda LarkinSusan Leitman, Floreliz Mendoza, Jamie Saunders, Sandra Sitar, Brandon Wilson, Kathryn Zephir, Michelle Conan-Cibotti, Hope DeCederfelt, Judith Starling, Phyllis Renehan, Meghan Kunchai, Ly Diep, Olga Vasilenko, Galina Yamshchikov

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

Results: Overall, injections by either method were well tolerated. There were no serious adverse events. Frequency of any local reactogenicity was 16/16 (100%) for Biojector compared to 11/15 (73%) for needle injections. There was no difference in HIV Env-specific antibody response between Biojector and needle delivery. Env-specific antibody responses were more than 10-fold higher in subjects receiving a booster dose of rAd5 vaccine than after a single dose delivered by either method regardless of interval between prime and boost

Conclusions: Biojector delivery did not improve antibody responses to the rAd5 vaccine compared to needle administration. Homologous boosting with rAd5 gene-based vectors can boost insert-specific antibody responses despite pre-existing vector-specific immunity.

Background: Needle-free delivery improves the immunogenicity of DNA vaccines but is also associated with more local reactogenicity. Here we report the first comparison of Biojector and needle administration of a candidate rAd5 HIV vaccine.

Methods: Thirty-one adults, 18-55 years, 20 naive and 11 prior rAd5 vaccine recipients were randomized to receive single rAd5 vaccine via needle or Biojector IM injection at 1010 PU in a Phase I open label clinical trial. Solicited reactogenicity was collected for 5 days; clinical safety and immunogenicity follow-up was continued for 24 weeks.

Original languageEnglish (US)
Article numbere106240
JournalPloS one
Volume9
Issue number9
DOIs
StatePublished - Sep 29 2014
Externally publishedYes

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ASJC Scopus subject areas

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

Cite this

Sarwar, U. N., Novik, L., Enama, M. E., Plummer, S. A., Koup, R. A., Nason, M. C., Bailer, R. T., McDermott, A. B., Roederer, M., Mascola, J. R., Ledgerwood, J. E., Graham, B. S., Adams, E., Berkowitz, N., Casazza, J., Costner, P., Gordon, I., Hendel, C. S., Holman, L., ... Yamshchikov, G. (2014). Homologous boosting with adenoviral serotype 5 HIV Vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial. PloS one, 9(9), [e106240]. https://doi.org/10.1371/journal.pone.0106240