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Meningococcal DiseasePhase 2NCT01018732

A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

A Phase 2 study testing Novartis Meningococcal (MenACWY-CRM) vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). Read more about this study

Who is it for?
Ages 16 to 23 yearsHealthy volunteers can take part
What is being tested?
Novartis Meningococcal (MenACWY-CRM) vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
3 sitesUnited States
Study dates
Jan 2010to Jul 2010
Phase
Phase 2
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 16 to 23 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
  • Female subjects were to be negative for pregnancy

Who cannot join

  • History of meningococcal disease
  • Receipt of any meningococcal vaccine outside of parent study (V59P6)
  • Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
  • receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
  • any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Rochester, Minnesota

  • Study site

    Seattle, Washington

Other trials in United States

About this study

Official title: A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Read the detailed description

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

Being tested
Novartis Meningococcal (MenACWY-CRM) vaccine
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence
Medical subject headings
Meningococcal Infections, Meningitis, Meningococcal, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novartis Meningococcal (MenACWY-CRM) vaccineBiological

    All subjects will have blood draws at Day 1, Day 8, and Day 29.

Study groups in NCT01018732
Study groupRoleWhat they receive
I: MenACWY-CRM vaccineExperimentalSubjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study.
Receives: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine
II: Licensed Polysaccharide Meningococcal vaccineExperimentalSubjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study.
Receives: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine
III: Meningococcal NaiveExperimentalSubjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study.
Receives: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination

    Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

    Measured: Day 1 (5 years after primary vaccination)

  2. Geometric Mean Titer After Booster Vaccination

    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

    Measured: Day 8, Day 29 (5 years after primary vaccination)

Secondary outcomes (7)

  1. Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination

    Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

    Measured: Day 1 (5 years after primary vaccination )

  2. Geometric Mean Titer at 5 Years After Primary Vaccination

    Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

    Measured: Day 1 (5 years after primary vaccination )

  3. Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination

    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.

    Measured: Day 7, Day 28 post booster (5 years after primary vaccination)

  4. Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination

    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.

    Measured: Day 7, Day 28 post booster (5 years after primary vaccination)

  5. Geometric Mean Ratio After Booster Vaccination

    Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1

    Measured: Day 8 and Day 29 (at 5 Years After Primary Vaccination)

  6. Percentage of Subjects With hSBA Seroresponse After Booster Vaccination

    For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.

    Measured: Day 8, Day 29 (5 years after primary vaccination)

  7. Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination

    Local and systemic reactions were solicited to assess safety and tolerability of vaccination

    Measured: Up to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01018732
Sponsor's protocol ID
V59P6E1
Status last verified
Jul 2015
First submitted
18 Nov 2009
Last updated
15 Jul 2015
Data monitoring committee
No

Publications

  • Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011 Mar;18(3):483-6. doi: 10.1128/CVI.00304-10. Epub 2010 Dec 22.

    PubMed 21177912

  • Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38.

    PubMed 23114372

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Novartis Meningococcal (MenACWY-CRM) vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 3 sites 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 2 inclusion and 5 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 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 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?

Yes. Results are posted in the registry (first posted 13 Sep 2011). 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?

Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination (time frame: Day 1 (5 years after primary vaccination)). The study lists 2 primary outcomes in all. 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 NCT01018732, which also lists 2 linked publications.

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 2015.

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