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Vaccine

Meningococcal Group B Vaccine for Gonorrhea

Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants aged 18 to 50 years of age inclusive on the day of enrollment
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 91 to day 451
Awards & highlights

Study Summary

This trial is testing a new vaccine to see if it can prevent gonorrhea. The study will last 36 months and 2200 people will be enrolled.

Who is the study for?
This trial is for men and women aged 18-50 who are in good health, not pregnant or breastfeeding, and have not had gonorrhea or chlamydia recently. They shouldn't have received a Meningococcal Group B vaccine before or taken certain antibiotics or immunosuppressants recently.Check my eligibility
What is being tested?
The study tests the effectiveness of the Bexsero vaccine against gonorrhea compared to a placebo. Participants won't know which they receive. The trial involves around 2,200 people and lasts about 16 months per participant.See study design
What are the potential side effects?
While specific side effects aren't listed here, vaccines like Bexsero may cause pain at the injection site, fever, fatigue, headache, muscle pain, chills and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 91 to day 451
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 91 to day 451 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination
Secondary outcome measures
Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination
Proportion of participants that experience at least one adverse event (AE) that results in withdrawal from study
Proportion of participants that experience at least one adverse event of special interest (AESI)
+2 more

Side effects data

From 2020 Phase 4 trial • 11 Patients • NCT04094883
73%
injection site (left deltoid) pain
36%
Injection site (left deltoid) tenderness
27%
Fatigue
18%
Injection site (left deltoid) erythema
18%
Subjective fever
18%
Nausea
18%
Headache
18%
Injection site (left deltoid) induration
9%
cough and nasal congestion
9%
upper respiratory tract infection
9%
Gastroesophageal reflux
9%
Injection site (left deltoid) swelling
9%
Abdominal pain
9%
chills
9%
lightheadedness
9%
pharyngitis
9%
wisdom teeth extraction
9%
flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
4CMenB Vaccine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1Experimental Treatment1 Intervention
Bexsero vaccine will be administered as an intramuscular injection in 1 mL single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.
Group II: Group 2Placebo Group1 Intervention
Placebo will be administered as an intramuscular injection in single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meningococcal Group B Vaccine
2021
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,483,037 Total Patients Enrolled
28 Trials studying Gonorrhea
46,294 Patients Enrolled for Gonorrhea

Media Library

Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04350138 — Phase 2
Gonorrhea Research Study Groups: Group 1, Group 2
Gonorrhea Clinical Trial 2023: Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) Highlights & Side Effects. Trial Name: NCT04350138 — Phase 2
Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04350138 — Phase 2
Gonorrhea Patient Testimony for trial: Trial Name: NCT04350138 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the United States Food and Drug Administration endorsed Meningococcal Group B Vaccine?

"An assessment of the Meningococcal Group B Vaccine's safety by our research team resulted in a rating of 2. This is due to Phase 2 trial data indicating its security, but there being no verifiable information demonstrating efficacy."

Answered by AI

Is there an open enrollment period for this research study?

"As per clinicaltrials.gov, this trial is still recruiting participants. It was first made available on December 29th 2020 and the most recent edit occurred on November 23rd 2022."

Answered by AI

In how many locales is this trial accessible?

"Patients can enroll in this research at 11 different sites, including the University of Pennsylvania HIV/AIDS Prevention Research Division in Philadelphia, Harlem Prevention Center, Columbia University Mailman School of Public Health in New york, and Emory University Hospital Midtown - Emory Clinic Infectious Diseases in Atlanta. Additionally, there are 7 other locations to choose from."

Answered by AI

How many participants are eligible to partake in this experiment?

"To adequately conduct this trial, 2200 participants must meet its inclusion criteria. These volunteers may come from the University of Pennsylvania HIV/AIDS Prevention Research Division in Philadelphia or Harlem Prevention Center, Columbia University, Mailman School of Public Health in New york City."

Answered by AI

Does the current protocol for this trial encompass elderly participants?

"This research initiative calls for participants aged between 18 and 50 years old. 203 trials are available to those under the age of majority, while 612 studies cater to patients above 65."

Answered by AI

Am I able to join this clinical investigation?

"Patients between 18 and 50 years old, diagnosed with gonorrhea, are eligible to take part in this clinical trial. Approximately 2200 participants will be accepted for the study."

Answered by AI

Who else is applying?

What state do they live in?
California
Georgia
What site did they apply to?
Emory University Hospital Midtown - Emory Clinic Infectious Diseases
SFDPH Bridge HIV Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Curious to know if this vaccine will prevent gonorrhea infections.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How much is the pay,& dose it pay the same day?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
2020. "Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04350138.
~656 spots leftby Oct 2025
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