Clinical trial NCT00560313: Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
Official title: A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Keywords: Meningococcal disease
prevention
vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults,18 through 50 years of age, who were or might be routinely exposed to N. meningitidis cultures

Exclusion Criteria:

* Previous ascertained or suspected disease caused by N. meningitidis;
* Pregnancy or breastfeeding;
* History of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
* Any present or suspected serious acute or chronic disease
* Known or suspected autoimmune disease or impairment /alteration of immune function

Primary outcomes:
measure: Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
timeFrame: One month after vaccinations
measure: Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
timeFrame: One month after vaccinations
measure: Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.
timeFrame: One month after vaccinations
measure: Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination
timeFrame: One month after vaccinations
measure: Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
timeFrame: One month after vaccinations
Secondary outcomes:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda USL 7 of Siena
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.