Meningococcal Group B Vaccine for Gonorrhea

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Pennsylvania HIV/AIDS Prevention Research Division, Philadelphia, PAGonorrheaMeningococcal Group B Vaccine - Biological
Eligibility
18 - 50
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Gonorrhea

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Salmonella typhi polysaccharide vaccine
1
Monovalent oral poliomyelitis vaccine (mOPV), Sabin strain
1
Phase 1:1a Low dose Group

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Day 91 to Day 451

Day 451
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)
Proportion of participants that experience at least one serious adverse event (SAE)
Proportion of participants with at least one medically attended adverse event (MAAE)
Day 451
Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination
Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination

Trial Safety

Safety Progress

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

Similar Trials

1
Salmonella typhi polysaccharide vaccine
1
Monovalent oral poliomyelitis vaccine (mOPV), Sabin strain
1
Phase 1:1a Low dose Group

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

2 Treatment Groups

Group 1
1 of 2
Group 2
1 of 2

Experimental Treatment

Non-Treatment Group

2200 Total Participants · 2 Treatment Groups

Primary Treatment: Meningococcal Group B Vaccine · Has Placebo Group · Phase 2

Group 1
Biological
Experimental Group · 1 Intervention: Meningococcal Group B Vaccine · Intervention Types: Biological
Group 2
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meningococcal Group B Vaccine
2019
Completed Phase 4
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 91 to day 451

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,172 Previous Clinical Trials
4,937,766 Total Patients Enrolled
27 Trials studying Gonorrhea
46,227 Patients Enrolled for Gonorrhea

Eligibility Criteria

Age 18 - 50 · All Participants · 8 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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.

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