Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

NCT00560313 | Completed Phase 2 Results DMC

• 2 other identifiers: V72P42007-001563-29
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningococcal Disease

Keywords

Meningococcal disease; prevention; vaccination

Outcome Measures

Primary Outcomes (5)

• Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.

  Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.

  One month after vaccinations

• Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.

  Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination

  One month after vaccinations

• Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.

  Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.

  One month after vaccinations

• Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination

  Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination

  One month after vaccinations

• Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.

  The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.

  One month after vaccinations

Study Arms (2)

4CMenB

EXPERIMENTAL

Biological: 4CMenB

MenACWY CRM

EXPERIMENTAL

Biological: Men ACWY CRM

Interventions

Men ACWY CRM BIOLOGICAL

A single dose of a 0.5 mL injectable solution

MenACWY CRM

4CMenB BIOLOGICAL

All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.

4CMenB

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Azienda USL 7 of Siena

Siena, 53100, Italy

Location

Related Publications (2)

• 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.

  PMID: 21177912 RESULT

• 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.

  PMID: 33020485 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: July 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 1, 2016
• Results First Posted: July 8, 2011

Record last verified: 2016-03

Locations

IT (1)