1270. A Phase I randomized, observer-blind, controlled, dose escalation trial of the safety and tolerability of two intramuscular doses of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory Syncytial Virus (RSV) SH antigen and a novel adjuvant DepoVaxTM, or SH antigen co-administered with Aluminum hydroxide, or placebo to healthy adults ≥50-64 years of age
Session: Poster Abstract Session: Clinical Infectious Diseases: Respiratory Infections
Friday, October 28, 2016
Room: Poster Hall
Posters
  • Final_CI1204_DepovaxRSV_poster_IDweek2016.pdf (3.4 MB)
  • Background:

    RSV causes lower respiratory tract infection in children, the immunosuppressed, and older adults. Currently there is no licensed vaccine for RSV infection. Subsequent to pre-clinical studies showing proof of principle, we are conducting a first-in-humans study of a novel RSV antigen (Ag) from the ectodomain of the Short Hydrophobic protein of RSV, formulated in the lipid and oil-based vaccine platform, DepoVaxTM, termed DPX-RSV(A). (NCT02472548)

    Methods:

    Healthy persons 50 to 64 years of age in good general health were enrolled beginning 05/2015, and randomized 2:2:1 in to two dose levels of a DPX-RSV(A) (10 or 25 µg), or synthetic RSV SH Ag with or without 125 µg Aluminum hydroxide, or saline placebo control. Dose escalation occurred in two sequential steps. A booster dose was given at Day (D) 56. Per protocol, if any participant in any vaccine group had anti-SH antibody (Ab) on D28, then the RSV(A)-Alum groups received a placebo booster. Participants and observers were blinded to allocation. Solicited local and general adverse events (AE) were collected on a memory aide D0-6 post-injection and unsolicited AE through to D28 post injection. Serious AE (SAE), medically attended AE (MAE), and potentially immune mediated disease (pIMD) were collected to D236. Blood samples for IgG Ab to SH Ag and hematologic or biochemical parameters were collected on D 0, 7, 28, 56, 63, 84 and 236; immunogenicity results are in progress. The study is ongoing.

    Results: With 40 participants enrolled, the mean age was 55.3 years (SD 3.97); 72.5% were female. Ab response was detected at D28, so RSV(A)-Alum subjects received placebo for dose 2 (D56). Pain was the most common local AE, reported in 14/40 (37.5%) overall; 14/15 had Grade (Gr) 1 pain and 1 had Gr 2 pain. No swelling or redness occurred D0-6. Pain did not increase with dose 2. Drowsiness (0-37.5% per group; all Gr 1) and muscle aches (0-25% per group; 7 subjects rated grade 1 and 1 rated Gr 3) were most common solicited general AE. Unsolicited AE occurred in 25-75% of subjects per group. MAEs occurred in all groups except RSV(A)-Alum 10 µg (total n=8). No pIMD or SAE occurred. Antigen-specific immune responses to RSV SH were demonstrated post vaccination.

    Conclusion:

    A novel RSV Ag from the SH protein of RSV, formulated in the lipid and oil-based vaccine platform, DepoVaxTM, had an acceptable safety and induced antigen specific antibody responses. 

    Joanne M. Langley, MD, FRCPC, FSHEA1, Lisa Macdonald, PhD2, Genevieve Weir, PhD3, Donna Mackinnon-Cameron, MMath4, Lingyun Ye, PhD5, Shelly Mcneil, MD, FRCPC, FIDSA4, Bert Schepens, PhD6, Xavier Saelens, PhD7, Marianne Stanford, PhD3 and Scott Halperin, MD8, (1)Pediatrics, Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre and Nova Scotia Health Authority), Halifax, NS, Canada, (2)Immunovaccine Inc., Halifax, NS, Canada, (3)Immunovaccine, Halifax, NS, Canada, (4)Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada, (5)Canadian Center for Vaccinology, Halifax, NS, Canada, (6)VIB, Gent, Belgium, (7)VIB Medical Biotechnology Center, UGent, Belgium, Gent, Belgium, (8)Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Halifax, NS, Canada

    Disclosures:

    J. M. Langley, Immunovaccine: Grant Investigator , Research support
    GlaxoSmithKline: Investigator , Research grant
    Novavax: Investigator , Research grant

    L. Macdonald, Immunovaccine Inc.: Employee , Salary

    G. Weir, Immunoivaccine: Employee , Salary

    D. Mackinnon-Cameron, None

    L. Ye, None

    S. Mcneil, GSK: Grant Investigator , Research grant and Research support

    B. Schepens, VBI: Employee , Salary

    X. Saelens, VIB: Employee and VIB and UGhent hold patent rights on SHe-based vaccines and treatment options for RSV: patent application WO2012/065997 (24.05.2012) with Bert Schepens, Walter Fiers, and Xavier Saelens as inventors. , Salary

    M. Stanford, Immunovaccine Inc.: Employee , Salary

    S. Halperin, None

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.