Neisseria Gonorrhoeae InfectionPhase 44CMenBNCT04094883
Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
A Phase 4 study testing Meningococcal Group B Vaccine in people with Neisseria Gonorrhoeae Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to test whether the group B meningitis vaccine (brand name Bexsero™) induces immune responses against the bacteria that causes gonorrhea. Participants: Approximately 15 Individuals who are 18-25 years of age that are not pregnant, HIV negative, have no history of congenital immunologic… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Gonorrhoeae Infection
- What is being tested?
- Meningococcal Group B Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2019to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and give informed consent
- Willingness to undergo all study procedures.
- Males or females between the ages of 18 to 25 at screening (inclusive).
- Good health, as determined by medical history and targeted physical exam.
- Participants agree to abstain from vaccines from study entry to 30 days after receipt of the second 4CMenB vaccine.
- Female participants of child bearing potential must have a negative urine pregnancy test at the screening visit, and prior to receipt of vaccines at study entry and week 5 visits. Self-reported history is acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, or tubal micro-inserts which eliminate child bearing potential of participant. If participating in sexual activity that could lead to pregnancy, women must agree to use a form of contraceptive until 28 days after completion of the vaccine series. At least one of the following methods must be used appropriately: Condoms (male) with or without spermicidal agent, Diaphragm or cervical cap with spermicide, Intrauterine device (IUD), or Hormone-based contraceptive. Self-report of a monogamous male partner who has a vasectomy is also acceptable.
Who cannot join
- Known allergy/sensitivity or any hypersensitivity to latex or any of the components of the study product or its formulation (see section 5.2 for a list of components).
- Participants who have received any vaccine directed against N. meningitidis serogroup B
- Serious illness or injury requiring hospitalization within 21 days prior to study entry.
- Current or prior history of a medical condition resulting in impaired immunity (such as HIV infection, inborn or acquired immunodeficiency syndromes, all cancers including leukemia or lymphoma, or the of use antineoplastic drugs or radiation treatment).
- Known active infection with HIV, Hepatitis C Virus (HCV ), or Hepatitis B Virus (HBV). This information will be obtained verbally from the participant.
- History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
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- Hemophilia or other bleeding diatheses.
- Receipt of anticoagulants (aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) are acceptable) within 14 days prior to study entry.
- Autoimmune disorders; mild autoimmune disorders, such as eczema, are not exclusionary and will be determined by the investigator.
- Use of any systemic immunomodulatory treatment, systemic corticosteroids, (inhaled and topical corticosteroids acceptable), investigational products, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
- Pregnant women and nursing mothers or women who are planning to become pregnant or breastfeed within 28 days after receipt of their second 4CMenB vaccine.
- Have received any licensed vaccine within 30 days prior to study vaccination.
- Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the study and up to 30 days after the last blood draw.
- Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Health Care
Chapel Hill, North Carolina, 27514
About this study
Official title: Institute for Global Health and Infectious Diseases (IGHID) 11911 - Cross-reactive N. Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
The purpose of this study is to test whether the group B meningitis vaccine (brand name Bexsero™) induces immune responses against the bacteria that causes gonorrhea.
Participants: Approximately 15 Individuals who are 18-25 years of age that are not pregnant, HIV negative, have no history of congenital immunologic disorder, and are not taking immune suppressive medications will be enrolled on this study at a single site, University of North Carolina at Chapel Hill (UNC-CH).
Procedures (methods): Participants will receive two-doses of an FDA-approved vaccine that provides protection from N. meningitidis infection according to the recommended dosing schedule. The first vaccine dose will be given to participants at the entry visit and the second vaccine dose will be given to participants at the week 5 visit. The participants will provide samples of blood as well as mucosal surface derived samples (urine and/or swabs) at four separate visits (entry, week 5, week 6, and week 7).
Read the detailed description
This study is a single center, single arm, interventional pilot study in which participants will receive two-doses of the 4CMenB vaccine according to the recommended administration schedule and will provide blood, pharyngeal swabs, and urine or self-collected vaginal swabs at each of four study visits.
The study population will include 15 individuals aged 18-25 years with no contraindication to vaccination and no known immune compromising medical condition or medication.
Participants will be seen for informed consent and eligibility screening. Enrolled participants will be given 1 dose of 4CMenB at enrollment and a second dose at week 5. Participants will be seen at entry, weeks 5, 6, and 7 for blood collection, pharyngeal swabs, and provide urine (male participants) or self-collected vaginal swabs collected for secondary screening and baseline immunologic testing.
Screening Evaluations Screening evaluations include: medical history, medication history within the past 60 days, vital signs, targeted physical exam, and pregnancy test for female participants of child bearing potential). Screening visit must be conducted no greater than 30 days prior to enrollment visit. The screening evaluation and enrollment visit can all occur on the same day. Participants may be re-screened one time.
Entry Evaluations
Entry evaluations will be collected PRIOR to phlebotomy, specimen collection, and vaccine administration:
Acute Illness Assessment will be completed before phlebotomy, specimen collection, and vaccine administration. Participants who have an acute illness may be rescheduled for their phlebotomy, specimen collection, and vaccine within their screening visit window.
Update medical history and concomitant medications. Conduct a targeted physical exam and collect vital signs [heart rate (HR), blood pressure (BP), oral temperature (Temp), respiration rate (RR), and weight] prior to phlebotomy to collect up to 60 mL of blood, specimen collection, and vaccine administration.
For females of reproductive potential, negative urine pregnancy testing results must be available before phlebotomy, specimen collection, and vaccine administration.
Samples to be stored for immunologic testing will be batch run at the end of the study:
pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from female participants), serum, and peripheral blood mononuclear cells (PBMC).
Post-Entry Evaluations
Week 5 Evaluations:
Acute Illness Assessment will be completed before phlebotomy, specimen collection, and vaccine administration. Participants who have an acute illness or who have taken exclusionary anticoagulant medications may be rescheduled for their vaccine within their screening visit window.
Update medical history and concomitant medications before phlebotomy and vaccine administration. Conduct a targeted physical exam and collect vital signs (HR, BP, Temp, RR) before phlebotomy to collect up to 60 mL of blood, specimen collection, and vaccine administration.
For females of reproductive potential, negative urine pregnancy testing results must be available before phlebotomy, specimen collection, and vaccine administration.
Week 5 laboratory evaluations will be collected PRIOR to vaccine administration:
Samples to be stored for immunologic testing will be batch run at the end of the study:
pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from female participants), serum, and PBMC.
Week 6 and Week 7 Evaluations:
Update medical history and concomitant medications prior to phlebotomy to collect up to 60 mL of blood and specimen collection.
Samples to be stored for immunologic testing will be batch run at the end of the study:
pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from female participants), serum, and PBMC.
- Conditions
- Neisseria Gonorrhoeae Infection
- Being tested
- Meningococcal Group B Vaccine
- Keywords
- Neisseria gonorrhoeae, Cross-reactive, Immune, Responses, Neisseria meningitidis, Vaccine
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Group B VaccineBiological
Also called Bexsero, 4-component Neisseria meningitidis group B vaccine, 4CMenB
All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
| Study group | Role | What they receive |
|---|---|---|
| 4CMenB Vaccine | Experimental | Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5. Receives: Biological: Meningococcal Group B Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgG binding to N. gonorrhoeae strain FA1090 surface antigens Outer-membrane vesicles (OMV) determined by ELISA in serum from entry visit and week 7 visit
Measured: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin M (IgM) Concentrations After Immunization
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgM binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
Measured: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin A (IgA ) Concentrations After Immunization
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgA binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
Measured: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Mean Change in Proportion of Cluster of Differentiation 4 Positive (CD4+) T Cells Expressing at Least Two Different Activation Markers After Immunization
Flow cytometry used to measure the number of CD4+ lymphocytes expressing Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), Interleukin-2 (IL-2), and Cluster of Differentiation 107a (CD107a) after in vitro stimulation with N. gonorrhoeae strain FA1090 Outer-membrane vesicles in circulating peripheral blood mononuclear cells (PBMC). The frequency of CD4+ T cells expressing at least two activation markers will be expressed as a proportion of total CD4+ lymphocytes. The change in frequency will be presented as the difference between frequency of cells measured at entry visit and at week 7 visit.
Measured: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start9 Oct 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neisseria Gonorrhoeae InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the group B meningitis vaccine (brand name Bexsero™).
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Joseph A Duncan, MD, PhD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094883
- Sponsor's protocol ID
- 19-1145
- Acronym
- 4CMenB
- Status last verified
- Jun 2021
- First submitted
- 16 Sep 2019
- Last updated
- 15 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institute for Global Health and Infectious Diseases (IGHID) 11911 - Cross-reactive N. Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
- ClinicalTrials.gov ID
- NCT04094883
- Acronym / sponsor ID
- 4CMenB / 19-1145
- Conditions
- Neisseria Gonorrhoeae Infection
- Keywords
- Neisseria gonorrhoeae, Cross-reactive, Immune, Responses, Neisseria meningitidis, Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 15 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether the group B meningitis vaccine (brand name Bexsero™) induces immune responses against the bacteria that causes gonorrhea.
Participants: Approximately 15 Individuals who are 18-25 years of age that are not pregnant, HIV negative, have no history of congenital immunologic disorder, and are not taking immune suppressive medications will be enrolled on this study at a single site, University of North Carolina at Chapel Hill (UNC-CH).
Procedures (methods): Participants will receive two-doses of an FDA-approved vaccine that provides protection from N. meningitidis infection according to the recommended dosing schedule. The first vaccine dose will be given to participants at the entry visit and the second vaccine dose will be given to participants at the week 5 visit. The participants will provide samples of blood as well as mucosal surface derived samples (urine and/or swabs) at four separate visits (entry, week 5, week 6, and week 7).
Detailed description
This study is a single center, single arm, interventional pilot study in which participants will receive two-doses of the 4CMenB vaccine according to the recommended administration schedule and will provide blood, pharyngeal swabs, and urine or self-collected vaginal swabs at each of four study visits.
The study population will include 15 individuals aged 18-25 years with no contraindication to vaccination and no known immune compromising medical condition or medication.
Participants will be seen for informed consent and eligibility screening. Enrolled participants will be given 1 dose of 4CMenB at enrollment and a second dose at week 5. Participants will be seen at entry, weeks 5, 6, and 7 for blood collection, pharyngeal swabs, and provide urine (male participants) or self-collected vaginal swabs collected for secondary screening and baseline immunologic testing.
Screening Evaluations Screening evaluations include: medical history, medication history within the past 60 days, vital signs, targeted physical exam, and pregnancy test for female participants of child bearing potential). Screening visit must be conducted no greater than 30 days prior to enrollment visit. The screening evaluation and enrollment visit can all occur on the same day. Participants may be re-screened one time.
Entry Evaluations
Entry evaluations will be collected PRIOR to phlebotomy, specimen collection, and vaccine administration:
Acute Illness Assessment will be completed before phlebotomy, specimen collection, and vaccine administration. Participants who have an acute illness may be rescheduled for their phlebotomy, specimen collection, and vaccine within their screening visit window.
Update medical history and concomitant medications. Conduct a targeted physical exam and collect vital signs [heart rate (HR), blood pressure (BP), oral temperature (Temp), respiration rate (RR), and weight] prior to phlebotomy to collect up to 60 mL of blood, specimen collection, and vaccine administration.
For females of reproductive potential, negative urine pregnancy testing results must be available before phlebotomy, specimen collection, and vaccine administration.
Samples to be stored for immunologic testing will be batch run at the end of the study:
pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from female participants), serum, and peripheral blood mononuclear cells (PBMC).
Post-Entry Evaluations
Week 5 Evaluations:
Acute Illness Assessment will be completed before phlebotomy, specimen collection, and vaccine administration. Participants who have an acute illness or who have taken exclusionary anticoagulant medications may be rescheduled for their vaccine within their screening visit window.
Update medical history and concomitant medications before phlebotomy and vaccine administration. Conduct a targeted physical exam and collect vital signs (HR, BP, Temp, RR) before phlebotomy to collect up to 60 mL of blood, specimen collection, and vaccine administration.
For females of reproductive potential, negative urine pregnancy testing results must be available before phlebotomy, specimen collection, and vaccine administration.
Week 5 laboratory evaluations will be collected PRIOR to vaccine administration:
Samples to be stored for immunologic testing will be batch run at the end of the study:
pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from female participants), serum, and PBMC.
Week 6 and Week 7 Evaluations:
Update medical history and concomitant medications prior to phlebotomy to collect up to 60 mL of blood and specimen collection.
Samples to be stored for immunologic testing will be batch run at the end of the study:
pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from female participants), serum, and PBMC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the group B meningitis vaccine (brand name Bexsero™).
| Arm | Type | Receives |
|---|---|---|
| 4CMenB Vaccine | Experimental | Biological: Meningococcal Group B VaccineParticipants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to understand and give informed consent
- Willingness to undergo all study procedures.
- Males or females between the ages of 18 to 25 at screening (inclusive).
- Good health, as determined by medical history and targeted physical exam.
- Participants agree to abstain from vaccines from study entry to 30 days after receipt of the second 4CMenB vaccine.
Key exclusion criteria (14 listed)
- Known allergy/sensitivity or any hypersensitivity to latex or any of the components of the study product or its formulation (see section 5.2 for a list of components).
- Participants who have received any vaccine directed against N. meningitidis serogroup B
- Serious illness or injury requiring hospitalization within 21 days prior to study entry.
- Current or prior history of a medical condition resulting in impaired immunity (such as HIV infection, inborn or acquired immunodeficiency syndromes, all cancers including leukemia or lymphoma, or the of use antineoplastic drugs or radiation treatment).
- Known active infection with HIV, Hepatitis C Virus (HCV ), or Hepatitis B Virus (HBV). This information will be obtained verbally from the participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal Group B VaccineAlso: Bexsero, 4-component Neisseria meningitidis group B vaccine, 4CMenBAll participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5. | Biological | 4CMenB Vaccine |
Primary outcome
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization
Time frame: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgG binding to N. gonorrhoeae strain FA1090 surface antigens Outer-membrane vesicles (OMV) determined by ELISA in serum from entry visit and week 7 visit
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin M (IgM) Concentrations After Immunization
Time frame: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgM binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin A (IgA ) Concentrations After Immunization
Time frame: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgA binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
Mean Change in Proportion of Cluster of Differentiation 4 Positive (CD4+) T Cells Expressing at Least Two Different Activation Markers After Immunization
Time frame: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Flow cytometry used to measure the number of CD4+ lymphocytes expressing Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), Interleukin-2 (IL-2), and Cluster of Differentiation 107a (CD107a) after in vitro stimulation with N. gonorrhoeae strain FA1090 Outer-membrane vesicles in circulating peripheral blood mononuclear cells (PBMC). The frequency of CD4+ T cells expressing at least two activation markers will be expressed as a proportion of total CD4+ lymphocytes. The change in frequency will be presented as the difference between frequency of cells measured at entry visit and at week 7 visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Duncan, MD, PhD principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meningococcal Group B Vaccine in people with Neisseria Gonorrhoeae Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization (time frame: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.