Meningococcal MeningitisPhase 1NCT01482052
Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis
A Phase 1 study testing meningococcal meningitis conjugate vaccine, quadrivalent in people with Meningococcal Meningitis and Meningococcal Infections, run by JN-International Medical Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis, Meningococcal Infections
- What is being tested?
- meningococcal meningitis conjugate vaccine, quadrivalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain
- For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions
- Age 18 to 50 years old
- Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (< two years post-menopause) or non surgically sterile women
- Persons with antibody titer(s) of <2 µg/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA
Who cannot join
- Age less than 18 years or over 50 years.
- History of Guillain-Barré syndrome (GBS).
- Pregnancy or lactation.
- History of meningococcal meningitis.
- History of invasive (clinical or laboratory diagnosis) meningococcal disease.
- History of meningococcal meningitis vaccination.
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- Screening laboratory abnormalities (in the opinion of the Investigator) that would raise safety concerns for participation in the study.
- Use of immunosuppressive drugs within 30 days prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents.
- History of anaphylactic shock, asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination.
- History of severe allergic disorders or autoimmune connective tissue disorders, including rheumatoid arthritis. A high sensitivity C-Reactive Protein (CRP) test at screening will be used as part of the assessment of autoimmune disorders by the Principal Investigator.
- Use of systemic antibiotics within 72 hours prior to study enrollment.
- History of cirrhosis.
- Positive results of testing for HepBsAg, Hepatitis C or HIV-1 or HIV-2 antibodies.
- Positive results of drug screen (amphetamine, THC, cocaine).
- Persons with antibody titer(s) of >2 µg/mL to serogroup (s) A, C, Y, or W 135 as measured by ELISA.
- Unable to understand all of the study requirements.
- Prisoners.
- Participation in a clinical trial in the last three months.
- History of any serious chronic medical or psychiatric illnesses.
- History of significant head trauma, alcohol or substance abuse or other medical illnesses that could cause a neurological deficit (e.g., cerebro-vascular disease) .
- Chronic medication use that, in the opinion of the Investigator, may influence or bias the clinical outcome of the trial.
- Individuals will be excluded from participation in this trial if they are judged by the Principal Investigator as having a significant impairment in their capacity for judgment or reasoning that compromise their ability to make decisions in their best interest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Controlled, Two Arm Phase 1 Clinical Trial of the Safety and Immunogenicity of Group A, C, Y & W-135 Meningococcal Polysaccharide DT Conjugate Vaccine: NmVac4-A/C/Y/W-135-DT™
The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine, as a measure of vaccine effectiveness.
Read the detailed description
Meningococcal disease is a potentially life-threatening bacterial infection. The disease most commonly is expressed as either meningococcal meningitis, an inflammation of the membranes surrounding the brain and spinal cord, or meningococcemia, the presence of bacteria in the blood. The most common symptoms include high fever, headache, neck stiffness, confusion, nausea, vomiting, lethargy, and rash. If not treated the disease can progress rapidly and can lead to shock and death, often within hours of the onset of symptoms. Neisseria meningitidis capsular polysaccharides are poor immunogens. However, conjugation of bacterial polysaccharides to immunogenic carrier proteins generally results in conjugates that induce strong anti-polysaccharide T-helper cell dependent immune responses, creating a longer-lasting immune response and thus protection against meningococcal infection. This study compares safety and antibody production induced by one intramuscular injection of either NmVac4-A/C/Y/W-135-DT or a licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. Participants will attend a screening visit up to 4 weeks prior to Day 0, then will attend study visits for 8 weeks. There will be a study phone call at Days 2-3, then a post-study telephone call to subjects to assess safety at 26 weeks.
- Conditions
- Meningococcal Meningitis, Meningococcal Infections
- Being tested
- meningococcal meningitis conjugate vaccine, quadrivalent
- Keywords
- Central Nervous System Infections, Meningitis, toxoid, Meningococcal vaccine, conjugate vaccines
- Medical subject headings
- Meningitis, Meningococcal, Meningococcal Infections, Central Nervous System Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meningococcal meningitis conjugate vaccine, quadrivalentBiological
Also called NmVac4-A/C/Y/W-135-DT™
NmVac4-A/C/Y/W-135-DT™conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 16 µg total diphtheria toxoid.
meningococcal meningitis conjugate vaccine, quadrivalentBiological
Meningococcal (Groups A,C,Y and W-135-DT) Polysaccharide Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 48 µg total diphtheria toxoid.
| Study group | Role | What they receive |
|---|---|---|
| Test Vaccine | Experimental | NmVac4-A/C/Y/W-135-DT™ conjugate vaccine Receives: Biological: meningococcal meningitis conjugate vaccine, quadrivalent |
| US Licensed Vaccine | Active comparator | Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Receives: Biological: meningococcal meningitis conjugate vaccine, quadrivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Reactions
local and systemic rates throughout the course of the study
Measured: up to 6 months
Secondary outcomes (1)
Immune Response
Antibody titers
Measured: 4 and 8 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal MeningitisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- JN-International Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudesh Nagavalli, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482052
- Sponsor's protocol ID
- JN-NM-001
- Status last verified
- Jan 2013
- First submitted
- 23 Nov 2011
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Controlled, Two Arm Phase 1 Clinical Trial of the Safety and Immunogenicity of Group A, C, Y & W-135 Meningococcal Polysaccharide DT Conjugate Vaccine: NmVac4-A/C/Y/W-135-DT™
- ClinicalTrials.gov ID
- NCT01482052
- Acronym / sponsor ID
- JN-NM-001
- Conditions
- Meningococcal Meningitis, Meningococcal Infections
- Keywords
- Central Nervous System Infections, Meningitis, toxoid, Meningococcal vaccine, conjugate vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- JN-International Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
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 evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine, as a measure of vaccine effectiveness.
Detailed description
Meningococcal disease is a potentially life-threatening bacterial infection. The disease most commonly is expressed as either meningococcal meningitis, an inflammation of the membranes surrounding the brain and spinal cord, or meningococcemia, the presence of bacteria in the blood. The most common symptoms include high fever, headache, neck stiffness, confusion, nausea, vomiting, lethargy, and rash. If not treated the disease can progress rapidly and can lead to shock and death, often within hours of the onset of symptoms. Neisseria meningitidis capsular polysaccharides are poor immunogens. However, conjugation of bacterial polysaccharides to immunogenic carrier proteins generally results in conjugates that induce strong anti-polysaccharide T-helper cell dependent immune responses, creating a longer-lasting immune response and thus protection against meningococcal infection. This study compares safety and antibody production induced by one intramuscular injection of either NmVac4-A/C/Y/W-135-DT or a licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. Participants will attend a screening visit up to 4 weeks prior to Day 0, then will attend study visits for 8 weeks. There will be a study phone call at Days 2-3, then a post-study telephone call to subjects to assess safety at 26 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Vaccine | Experimental | Biological: meningococcal meningitis conjugate vaccine, quadrivalentNmVac4-A/C/Y/W-135-DT™ conjugate vaccine |
| US Licensed Vaccine | Active comparator | Biological: meningococcal meningitis conjugate vaccine, quadrivalentMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain
- For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions
- Age 18 to 50 years old
- Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (< two years post-menopause) or non surgically sterile women
- Persons with antibody titer(s) of <2 µg/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA
Key exclusion criteria (22 listed)
- Age less than 18 years or over 50 years.
- History of Guillain-Barré syndrome (GBS).
- Pregnancy or lactation.
- History of meningococcal meningitis.
- History of invasive (clinical or laboratory diagnosis) meningococcal disease.
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 meningitis conjugate vaccine, quadrivalentAlso: NmVac4-A/C/Y/W-135-DT™NmVac4-A/C/Y/W-135-DT™conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 16 µg total diphtheria toxoid. | Biological | Test Vaccine |
| meningococcal meningitis conjugate vaccine, quadrivalentMeningococcal (Groups A,C,Y and W-135-DT) Polysaccharide Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 48 µg total diphtheria toxoid. | Biological | US Licensed Vaccine |
Primary outcome
Adverse Reactions
Time frame: up to 6 months
local and systemic rates throughout the course of the study
1 secondary outcome
Immune Response
Time frame: 4 and 8 weeks after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
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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.
Sudesh Nagavalli, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing meningococcal meningitis conjugate vaccine, quadrivalent in people with Meningococcal Meningitis and Meningococcal Infections, run by JN-International Medical Corporation 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 5 inclusion and 22 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 14 Jan 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Reactions (time frame: up to 6 months). 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 14 Jan 2013.