Meningococcal DiseasePhase 1/2NCT01782066
Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines
A Phase 1/2 study testing MEN-ACYW135 reduced-dose intradermal administration in people with Meningococcal Disease, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- MEN-ACYW135 reduced-dose intradermal administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Feb 2014
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meningococcal C naive subjects are required to fulfill all of the following criteria:
- Age ≥ 30 years
- Good health according to the investigator
- Willingness and ability to adhere to the study regimen
- Able to give informed consent
- Meningococcal C experienced subjects are required to fulfill all of the following criteria:
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- Age ≥ 18 years
- Good health according to the investigator
- Willingness and ability to adhere to the study regimen
- Able to give informed consent
Who cannot join
- Meningococcal C naïve subjects should not have:
- Known previous invasive meningococcal infection
- Known or suspected previous vaccination against meningococcal disease
- Known or suspected allergy against any of the vaccine components
- Close contact in the last 60 days with a person known to be Neisseria positive
- History of unusual or severe reactions to any previous vaccination
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- Family history of Guillain-Barré Syndrome
- Known or suspected immune deficiency, either congenital or acquired
- Administration of plasma or blood products less than three months prior to inclusion in the study
- Pregnancy (breastfeeding is allowed)
- Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
- Any infectious disease
- Bleeding disorders or use of anticoagulants
- Participation as a subject in another trial in the last 3 months
- Meningococcal C experienced subjects should not have:
- Known or suspected allergy against any of the vaccine components
- Known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide)
- Close contact in the last 60 days with a person known to be Neisseria positive
- History of unusual or severe reactions to any previous vaccination
- Family history of Guillain-Barré Syndrome
- Known or suspected immune deficiency, either congenital or acquired
- Administration of plasma or blood products less than three months prior to inclusion in the study
- Pregnancy (breastfeeding is allowed)
- Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
- Any infectious disease
- Bleeding disorders or use of anticoagulants
- Participation as a subject in another trial in the last 3 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
Official title: Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).
Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the vaccine.
- Conditions
- Meningococcal Disease
- Being tested
- MEN-ACYW135 reduced-dose intradermal administration
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEN-ACYW135 reduced-dose intradermal administrationBiological
Also called Menveo, Nimenrix
Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.
| Study group | Role | What they receive |
|---|---|---|
| Menveo, dose escalating | Experimental | Not described Receives: Biological: MEN-ACYW135 reduced-dose intradermal administration |
| Nimenrix, dose escalating | Experimental | Not described Receives: Biological: MEN-ACYW135 reduced-dose intradermal administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)
Measured: 28 days
Secondary outcomes (1)
Local and systemic adverse events (subject log and investigator inspection).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.G. Visser, MD, PhD, Leiden University Medical Center
- Investigators
- Leo Visser, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782066
- Sponsor's protocol ID
- MENID-1
- Other IDs
- 2012-003085-41
- Status last verified
- Oct 2014
- First submitted
- 30 Jan 2013
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jonker EFF, van Ravenhorst MB, Berbers GAM, Visser LG. Safety and immunogenicity of fractional dose intradermal injection of two quadrivalent conjugated meningococcal vaccines. Vaccine. 2018 Jun 18;36(26):3727-3732. doi: 10.1016/j.vaccine.2018.05.064. Epub 2018 May 16.
PubMed 29778515
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).
- ClinicalTrials.gov ID
- NCT01782066
- Acronym / sponsor ID
- MENID-1
- Conditions
- Meningococcal Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Feb 2013 (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.
Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menveo, dose escalating | Experimental | Biological: MEN-ACYW135 reduced-dose intradermal administration |
| Nimenrix, dose escalating | Experimental | Biological: MEN-ACYW135 reduced-dose intradermal administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 30 years
- Good health according to the investigator
- Willingness and ability to adhere to the study regimen
- Able to give informed consent
- Meningococcal C experienced subjects are required to fulfill all of the following criteria:
Key exclusion criteria (27 listed)
- Known previous invasive meningococcal infection
- Known or suspected previous vaccination against meningococcal disease
- Known or suspected allergy against any of the vaccine components
- Close contact in the last 60 days with a person known to be Neisseria positive
- History of unusual or severe reactions to any previous vaccination
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 |
|---|---|---|
| MEN-ACYW135 reduced-dose intradermal administrationAlso: Menveo, NimenrixModified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines. | Biological | Menveo, dose escalating, Nimenrix, dose escalating |
Primary outcome
Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)
Time frame: 28 days
1 secondary outcome
Local and systemic adverse events (subject log and investigator inspection).
Time frame: 28 days
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 29 Oct 2014.
- Derived from this study: PubMed 29778515Jonker EFF, van Ravenhorst MB, Berbers GAM, Visser LG. Safety and immunogenicity of fractional dose intradermal injection of two quadrivalent conjugated meningococcal vaccines. Vaccine. 2018 Jun 18;36(26):3727-3732. doi: 10.1016/j.vaccine.2018.05.064. Epub 2018 May 16.
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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.
Leo Visser, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MEN-ACYW135 reduced-dose intradermal administration in people with Meningococcal Disease, run by Leiden University Medical Center at 1 site in Netherlands.
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 10 inclusion and 27 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 29 Oct 2014. 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 Netherlands. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782066, which also lists 1 linked publication.
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 29 Oct 2014.