Date: 2017-11-09
Type of
information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Bavarian Nordic (Denmark)
Product: MVA-BN® RSV vaccine
Action
mechanism: vaccine. MVA-BN® RSV is a universal vaccine candidate designed to induce protective immune responses against both subtypes (A & B) of the respiratory syncytial virus (RSV).
Disease: respiratory syncytial virus infections
Therapeutic
area: Infectious diseases
Country:
Trial
details:
- The randomized, placebo-controlled study enrolled 421 subjects aged 55 and older, at 12 centers across the United States. These subjects were enrolled into four active arms of the study, which examined the effects of both a high (5x108) and low (1x108 dose, administered as either one or two vaccinations (day 0, 28) and compared to a placebo arm.
Latest
news:
-
• On November 9, 2017, Bavarian Nordic announced that dosing has commenced in the Phase 2 extension study of MVA-BN® RSV, a universal vaccine candidate designed to elicit a broad antibody and T-cell response against multiple respiratory syncytial virus (RSV) antigens. This study is designed to help determine whether a single shot administration of vaccine is required annually, or if it remains effective over multiple seasons. The vaccine has previously shown to induce an immune response against RSV for a single season.
-
The initial Phase 2 study enrolled 421 volunteers to determine dose and response to MVA-BN RSV. This added booster portion of the study will enroll 86 of these subjects to receive a single shot of either low (1x108) or high (5x108) dose of the vaccine. The study will determine what, if any, boosting effect is seen from the additional shot when compared to the balance of subjects in the Phase 2 study, helping to determine whether MVA-BN RSV should be administered annually, or if the durability of the vaccine could extend across multiple seasons.
• On September 21, 2017, Bavarian Nordic announced initial 6 month follow-up data from the Phase 2 trial of MVA-BN® RSV. The randomized, placebo-controlled trial, evaluated the safety, tolerability and immunogenicity of the recombinant vaccine in 421 healthy adults aged 55 and older. At 6 month follow up, a persistent antibody response against multiple RSV targets can still be observed. Updated clinical plans for the RSV vaccine will now include a human challenge study. Anticipated to initiate recruitment in the second half of 2018 the placebo-controlled study will explore the protective effects of MVA-BN RSV. Bavarian Nordic intends to use evidence from the challenge study to assist in the planning and design of late phase RSV studies as well as demonstrating early evidence regarding efficacy of MVA-BN RSV in preventing disease in healthy volunteers subsequently exposed to live RSV.
- Bavarian Nordic will partner with a global CRO to develop a novel and differentiated approach to the RSV challenge model. Previous attempts at RSV challenge studies have historically been seen as lacking in sufficient measurable outcomes, which may be associated with the relatively low virulence of the virus administered to volunteers. The CRO has developed a new primary isolate of RSV which, in infectivity assays, has demonstrated a degree of virulence and pathogenicity more commonly associated with circulating, wild-type strains. This new model will potentially allow Bavarian Nordic to more accurately assess the protective benefits of its vaccine when confronted with a virulent RSV infection.
- • On June 27, 2017, Bavarian Nordic announced positive results for MVA-BN® RSV. The vaccine was shown to be both well tolerated and immunogenic at both dose levels investigated. The study confirmed the hypothesis that MVA-BN RSV is the first vaccine candidate designed to induce a broad and robust immune response against five distinct RSV proteins following a single shot or booster vaccination, using Bavarian’s proprietary viral platform MVA-BN (Modified Vaccinia Ankara – Bavarian Nordic).
- A single vaccination induced the highest booster responses in both antibodies and T cells against RSV compared to a prime-boost regime. Compared to the subjects receiving placebo, a significant boost (2-4 fold) in antibodies was observed 2 weeks post the single booster vaccination. This included neutralizing and total antibodies (IgG) against RSV, as well as IgA antibodies, which are associated with mucosal responses and are thought to play an important role in protection against RSV. Significant T cell responses (5-10 fold) to all five RSV proteins were observed in the majority of subjects 1 week post the single booster vaccination.
- At the 3 month time point post vaccination the immune responses induced by the two active doses investigated demonstrated significant boosts over placebo. Immune responses were seen to be similar across all active doses, potentially confirming the results seen with the 1x108 dose tested in a Phase 1 which also demonstrated durable antibody responses 6 months post vaccination.
- Blood samples from the 6 month time point post vaccination are currently being tested in this Phase 2 study. Subjects that received a single vaccination with either dose will be given an additional booster later this year and followed for another RSV season, to help establish the immune responses 12 months post vaccination and the effect of another booster vaccination.
Is
general: Yes
