Dynavax Technologies has revealed promising topline outcomes from the initial part of its Phase I/II clinical trial, comparing its shingles vaccine candidate Z-1018 against GSK’s Shingrix in individuals aged 50 to 69 years.
In the study, Z-1018 showed antibody and CD4⁺ T cell responses on par with Shingrix, coupled with a good tolerability profile.
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The first part of the trial assessed 50mcg, 100mcg, and 200mcg dose levels of the gE antigen and two adjuvant formulations and also dosing intervals at 8 and 12 weeks.
The primary safety measure was the rate of local and systemic post-injection reactions (PIRs) within seven days post-injection.
Immunogenicity was gauged by vaccine response rates (VRR) for anti-gE IgG antibodies and gE-specific CD4+ T cells, determined four weeks post the second dose.
The composite VRR included subjects who met the criteria of the antibody, as well as T-cell response.
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By GlobalDataFor the dosage and treatment schedule selected to progress to the second part of the study, Z-1018 demonstrated humoral immune response at a rate of 100%, slightly higher than Shingrix, which achieved a 96.9% response.
On the cellular immunity side (CD4+ T-cell response), Z-1018 had an 89.7% response rate, slightly below Shingrix’s 93.5%. This led to an overall vaccine response rate of 89.7% for participants receiving Z-1018, compared to 90.3% for those receiving Shingrix.
The vaccine candidate was also associated with lower incidences of moderate to severe local and systemic PIRs.
At the selected dose and regimen for the upcoming trial phase, 12.5% of Z-1018 recipients experienced grade 2 or 3 local PIRs, and 27.5% reported systemic PIRs, which were significantly less than the 52.6% and 63.2% reported for Shingrix, respectively.
Safety evaluations, overseen by a monitoring committee, have not raised any concerns during this ongoing study.
Following these findings, Dynavax is set to proceed with Part 2 of the Phase I/II programme, targeting the adult population aged 70 years and above, with the trial expected to commence in the latter half of this year.
Dynavax CEO Ryan Spencer said: “We met our goal for this study, as the results show immune responses comparable to Shingrix, along with a favourable tolerability profile, and provide the basis for selecting the dose and regimen to advance into further development.”
Last year, Dynavax dosed the first subject in a Phase I/II trial of Z-1018.
