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Meningococcal Group B Vaccine for Gonorrhea
Study Summary
This trial will test a meningitis vaccine to see if it also protects against gonorrhea. It will enroll 50 adults in the US, who will get either the vaccine or a placebo, and be followed for 8 months. The primary goal is to see if the vaccine leads to a better immune response against gonorrhea in the rectum.
- Gonorrhea
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 11 Patients • NCT04094883Trial Design
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- You have had a severe allergic reaction or serious side effects to a vaccine or vaccine-related products in the past.You have a severe allergy or strong reaction to latex.You have a weakened immune system due to a medical condition or are taking medication that suppresses your immune system.You have ever had meningococcal or gonococcal infection in any part of your body.You have received a vaccine for meningococcal serogroup B in the past.You have a history of autoimmune disease or significant health issues with your heart, lungs, stomach, liver, joints, or kidneys.You currently drink alcohol or have a history of using recreational or narcotic drugs that could affect your ability to follow the study guidelines.You have a history of bleeding problems or are currently taking medications that prevent blood clotting or reduce inflammation.You have a high fever (temperature of 38.0 degrees Celsius or higher) or are currently experiencing a severe illness on the first day of the study.You have been diagnosed with either type 1 or type 2 diabetes, including cases that can be managed with diet alone.
- Group 1: 4CMenB
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are we still enrolling patients in this trial?
"According to the most recent information available on clinicaltrials.gov, this trial is still seeking patients. It was first posted on November 1st, 2021 and last updated on November 10th, 2022."
How can I get involved in this clinical research?
"This clinical trial is looking for 60 patients, aged 18-49, who currently have gonorrhea. To be eligible for the study, participants must also meet the following criteria: provide written informed consent; have a body mass index (BMI) of 18.5 or higher but less than 35 kg/m2; safety labs within normal ranges*; for female subjects only**: if of childbearing potential***, use contraception from 30 days before study product administration through the end of study participation; be available and willing to participate for the duration of this trial; be in good health based on physical examination, vital signs*,"
Would this research project benefit from a more mature test subject?
"Eligibility for this study is restricted to adults aged 18-49. There are 6 trials available for minors and 11 studies for seniors."
How many people are currently signed up for this experiment?
"That is correct, the clinical trial mentioned is still recruiting patients. The listing was first made public on November 1st, 2021 and was last edited two weeks ago on November 10th, 2022. Currently, the study is only enrolling 60 individuals at a single location."
Are there any risks associated with the Meningococcal Group B Vaccine?
"Meningococcal Group B Vaccine is currently in Phase 2 of clinical trials. While there is data supporting its safety, more research needs to be done to confirm its efficacy."
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