Table of contents
- Clinical trial overview
- Studies and target populations
- Main endpoints and what they measure
- Trial design and phases
- Patient-friendly explanation of key terms
Clinical trial overview
In the trial data provided, HEPATITIS B SURFACE ANTIGEN (RDNA) ADSORBED ON ALUMINIUM PHOSPHATE [PRODUCED IN S. CEREVISAE CELLS BY RDNA] appears as part of vaccine studies rather than as a stand-alone treatment. The studies are interventional, which means researchers give a product and then measure what happens.[1][2]
The main goals are to check safety, tolerability, and immune response. One study also looks at disease score changes in people with myasthenia gravis.[1][2]
Studies and target populations
One completed Phase 1 study, NCT05082285, enrolled 703 participants and studied meningococcal infection-related vaccine responses. The brief summary says the study aimed to evaluate safety and reactogenicity, meaning how often expected short-term reactions happen after vaccination, and to assess immune response against meningococcal serogroups A, C, W, Y, and B indicator strains.[1]
A second authorised Phase 1b/2 study, 2025-522406-20-00, enrolled 135 adult participants with generalized myasthenia gravis (gMG) and ocular myasthenia gravis (oMG). It studied IM-101, with safety and tolerability as well as possible efficacy compared with placebo, in AChR antibody-positive gMG, AChR antibody-negative gMG, and oMG.[2]
These studies show that the substance is being used in different research settings: one in vaccine combination research and one in a neuromuscular disease study. The trial data do not describe this substance as a treatment on its own; they show how it is included in clinical research products.[1][2]
Main endpoints and what they measure
In NCT05082285, the primary outcomes include the number and percentage of participants with solicited administration site and systemic events during 7 days after each vaccination. This means researchers tracked reactions at the injection site and body-wide symptoms after the vaccine.[1]
The same study also measured unsolicited adverse events during 30 days after each vaccination, plus medically attended adverse events, serious adverse events, adverse events leading to withdrawal, and adverse events of special interest throughout the study. These are different levels of unwanted health events, from any reported problem to events that are serious or important enough to need special attention.[1]
That study also measured human serum bactericidal assay (hSBA) results, which are lab tests that check whether blood can help kill bacteria. The outcomes included the percentage of participants with hSBA titres at or above the lower limit of quantitation and the hSBA geometric mean titres for meningococcal serogroups A, C, W, Y, and B indicator strains at several time points.[1]
In 2025-522406-20-00, the main safety outcomes were treatment-emergent adverse events, serious adverse events, adverse events leading to stopping study treatment, and adverse events of special interest. The study also measured changes from baseline to Week 16 in the MG-ADL total score for gMG cohorts and the MGII ocular score for the oMG cohort.[2]
Trial design and phases
Both listed studies are early-stage clinical trials. NCT05082285 is a Phase 1 interventional study and is completed, while 2025-522406-20-00 is a Phase 1b/2 multicenter, randomized, double-blind, placebo-controlled study and is authorised.[1][2]
The first study compared multiple vaccine formulations and combinations, including MenABCWY-1st Gen, MenABCWY-2nd Gen, MenB vaccine, and MenACWY-TT vaccine. The second study compared IM-101 with placebo and included dose-escalation cohorts and expansion cohorts.[1][2]
Patient-friendly explanation of key terms
Reactogenicity means the short-term reactions that can happen after a vaccine, such as symptoms at the injection site or general symptoms in the body.[1]
Randomized means participants are assigned by chance to different study groups, which helps make the comparison fair.[2]
Double-blind means that neither the participants nor the researchers know who gets the study treatment or placebo during the study, which helps reduce bias.[2]
Placebo means an inactive comparison treatment used to help show whether the study product has an effect.[2]
MG-ADL is a score used to measure daily-life problems in myasthenia gravis, and MGII ocular score measures eye-related symptoms in ocular myasthenia gravis.[2]
