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Tests treatment safety and results for Neisseria Meningitidis Serogroup B
Official title A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
ClinicalTrials.gov ID: NCT07395739
What this study is testing
What is Bexsero®?
Bexsero® is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for neisseria meningitidis serogroup b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male or female participants aged 18 to 50 years (inclusive) at the time of screening, who can provide valid legal identification.
- Willing and able to give written informed consent before any study-related activities are carried out and must be able to understand the full nature...
- Willing and able to comply with all study procedures and available for the entire duration of the study follow-up.
- Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at screening.
- For female participants at least 1 of the following conditions must apply: i) Is not of childbearing potential (WONCBP), defined as surgically...
You likely can't join if
- 1\. Oral temperature \>37.5°C at screening or prior to vaccination\ 2. Previous vaccination with any Group B meningococcal vaccine (including GSK's...
- 3\. Individuals with abnormal findings in pre-vaccination laboratory tests, vital signs, physical examination, or electrocardiogram (ECG) that are...
- 5\. Administration of any live-attenuated vaccine within 14 days (inclusive) prior to vaccination, or any other subunit, inactivated, or recombinant...
- 9\. Receipt of blood products and/or immunoglobulins within 3 months prior to vaccination, or planned administration during the study period.\ 10...
- 12\. Participants with encephalopathy, uncontrolled epilepsy, convulsions, other progressive neurological disorders, or a significant personal...
- 13\. Contraindications to intramuscular injection, including, but not limitedto: diagnosed thrombocytopenia, any coagulation disorder, or current...
See the full eligibility criteria
- Healthy male or female participants aged 18 to 50 years (inclusive) at the time of screening, who can provide valid legal identification.
- Willing and able to give written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Willing and able to comply with all study procedures and available for the entire duration of the study follow-up.
- Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at screening.
- For female participants at least 1 of the following conditions must apply: i) Is not of childbearing potential (WONCBP), defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral...
- Females should not be currently breastfeeding, and should not breastfeed for the duration of the study.
- Male participants are able to participate if they: i) Practice true abstinence (where this is consistent with their usual lifestyle); or ii) Are surgically sterilized (performed at least 6 months prior and documented to...
- 1\. Oral temperature \>37.5°C at screening or prior to vaccination\ 2. Previous vaccination with any Group B meningococcal vaccine (including GSK's Bexsero® or Pfizer's Trumenba®) or a history of invasive disease caused...
- 3\. Individuals with abnormal findings in pre-vaccination laboratory tests, vital signs, physical examination, or electrocardiogram (ECG) that are deemed clinically significant by the Investigator or delegate. \ 4...
- 5\. Administration of any live-attenuated vaccine within 14 days (inclusive) prior to vaccination, or any other subunit, inactivated, or recombinant protein vaccine within 7 days (inclusive) before vaccination.\ 6...
- 9\. Receipt of blood products and/or immunoglobulins within 3 months prior to vaccination, or planned administration during the study period.\ 10. Participants who have donated or lost more than 450 mL of blood within...
- 12\. Participants with encephalopathy, uncontrolled epilepsy, convulsions, other progressive neurological disorders, or a significant personal history of psychiatric disorders.
- 13\. Contraindications to intramuscular injection, including, but not limitedto: diagnosed thrombocytopenia, any coagulation disorder, or current treatment with anticoagulants. 14. Asplenia, functional asplenia, or...
- 16\. Participation in another clinical trial involving an investigational or unregistered product (drug, vaccine, device, etc.) within 30 days prior to vaccination, or planned participation in any other clinical trial...
- 18\. Participants with skin conditions that in the opinion of the investigator or delegate may interfere with the assessment of local adverse reactions (e.g., tattoos at the injection site, psoriasis, plaques affecting...
- 19\. Any other condition which, in the opinion of the Investigator or delegate, may compromise the assessment of the trial objectives.
The study team makes the final eligibility decision.
Where it's taking place
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Perth, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.