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.
2014
Journal Article
Authors:
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.
Secondary:
PLoS One
Volume:
9
Pagination:
e106240
Issue:
9
PMID:
25264782
DOI:
10.1371/journal.pone.0106240
Keywords:
Adenoviridae; Adolescent; Adult; AIDS Vaccines; Enzyme-Linked Immunosorbent Assay; Genetic Vectors; HIV Antibodies; Humans; Middle Aged; Young Adult
Abstract:
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.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.TRIAL REGISTRATION: Clinicaltrials.gov NCT00709605 NCT00709605.
