All > Vaccine > Experimental

Meningococcal Group B Vaccine for Gonorrhea

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clinical and Translational Research Center (CTRC) at University of North Carolina (UNC) Hospitals and/or at UNC Global Clinical Research North, Chapel Hill, NCGonorrheaMeningococcal Group B Vaccine - Biological
Eligibility
18 - 35
Male
What conditions do you have?
Select

Study Summary

This trial tests whether the group B meningitis vaccine protects from Neisseria gonorrhoeae infection. Approximately 120-140 participants will be enrolled and receive 2 doses of vaccine.

Eligible Conditions
  • Gonorrhea

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Almond
1
Salmonella typhi polysaccharide vaccine
1
Part A - "Low" Dose

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: between 1 and 10 days after N. gonorrhoeae inoculation (between study day 58 and study day 123)

Day 123
Infectivity of N. gonorrhoeae inoculum
Proportion of participants that develop macroscopic urethritis
Proportion of participants that develop symptomatic microscopic urethritis
Time to develop macroscopic urethritis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Almond
1
Salmonella typhi polysaccharide vaccine
1
Part A - "Low" Dose

Side Effects for

4CMenB Vaccine
73%injection site (left deltoid) pain
36%Injection site (left deltoid) tenderness
27%Fatigue
18%Injection site (left deltoid) erythema
18%Injection site (left deltoid) induration
18%Nausea
18%Subjective fever
18%Headache
9%flushing
9%upper respiratory tract infection
9%Abdominal pain
9%cough and nasal congestion
9%Injection site (left deltoid) swelling
9%chills
9%Gastroesophageal reflux
9%pharyngitis
9%lightheadedness
9%wisdom teeth extraction
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04094883) in the 4CMenB Vaccine ARM group. Side effects include: injection site (left deltoid) pain with 73%, Injection site (left deltoid) tenderness with 36%, Fatigue with 27%, Injection site (left deltoid) erythema with 18%, Injection site (left deltoid) induration with 18%.

Trial Design

1 Treatment Group

Experimental arm
1 of 1

Experimental Treatment

140 Total Participants · 1 Treatment Group

Primary Treatment: Meningococcal Group B Vaccine · No Placebo Group · Phase 2

Experimental armExperimental Group · 7 Interventions: Meningococcal Group B Vaccine, Ceftriaxone, Cefixime, Neisseria gonorrhoeae strain FA1090, Ciprofloxacin, Tetanus-diptheria Vaccine, Influenza Vaccine · Intervention Types: Biological, Drug, Drug, Biological, Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meningococcal Group B Vaccine
2019
Completed Phase 4
~20
Ceftriaxone
2019
Completed Phase 4
~4340
Cefixime
2012
Completed Phase 2
~800
Ciprofloxacin
2014
Completed Phase 4
~8080
Influenza Vaccine
2010
Completed Phase 4
~6900

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: between 1 and 10 days after n. gonorrhoeae inoculation (between study day 58 and study day 123)

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,380 Previous Clinical Trials
3,928,924 Total Patients Enrolled
5 Trials studying Gonorrhea
1,924 Patients Enrolled for Gonorrhea
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,165 Previous Clinical Trials
4,936,881 Total Patients Enrolled
27 Trials studying Gonorrhea
48,287 Patients Enrolled for Gonorrhea
Joseph A Duncan, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Gonorrhea
11 Patients Enrolled for Gonorrhea

Eligibility Criteria

Age 18 - 35 · Male Participants · 34 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are taking warfarin.
You are taking aspirin.
You are taking furosemide or other similar medications that help your body get rid of extra fluid.
You are taking a certain type of antibiotic called aminoglycoside.
You are taking warfarin.
You cannot take antacids, multivitamins, or other dietary supplements that contain magnesium, calcium, aluminum, iron, or zinc.
You have never had a seizure before, except for febrile seizures when you were a child.
You cannot take medication that contains caffeine.
I'm sorry, this is not a criterion. Tizanidine is a medication used to treat muscle spasms, but it does not provide enough context for me to know what screening criteria you are referring to. Please provide more information or clarification.
Not applicable. This is just the name of a medication and not a screening criteria.
This criterion is incomplete and requires more information to provide a summary. Can you please provide more context?
You are taking sucralfate or didanosine in chewable or buffered tablet form.
References

Frequently Asked Questions

How many participants has this research project attracted thus far?

"Indeed, the records on clinicaltrials.gov indicate that recruitment is still ongoing for this medical trial which had its inception on April 18th 2022 and has since been updated as recently as May 19th 2022. The current goal of the study is to acquire 140 participants from a single location." - Anonymous Online Contributor

Unverified Answer

Is my profile fitting of the criteria for participation in this research endeavor?

"The prerequisites for this medical survey are a confirmed diagnosis of gonorrhea and an age between 18 to 35 years. At present, 140 subjects are being accepted into the study." - Anonymous Online Contributor

Unverified Answer

Does this experiment currently accept participants?

"According to clinicaltrials.gov, this trial is accepting participants and has been available for enrollment since April 18th 2022. The record was recently renewed on May 19th of the same year." - Anonymous Online Contributor

Unverified Answer

Are those aged over 40 being included in the current trial?

"This trial requires participants to be between 18 and 35 years old." - Anonymous Online Contributor

Unverified Answer

Has the Food and Drug Administration certified Meningococcal Group B Vaccine as safe?

"There is empirical evidence suggesting the safety of Meningococcal Group B Vaccine, so it was assigned a score of 2. However, no clinical data exists to support its effectiveness as this is only in Phase 2 trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top