A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

A Phase 3b, Single-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-risk Adults

The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).

In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease; Meningococcal Meningitis
• Intervention / Treatment: Biological: Recombinant meningococcal B + OMV NZ

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • UOC Medicina Interna 2, Azienda Ospedaliera Universitaria Senese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment;
2. Able to comprehend and follow all required study procedures;
3. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
5. Who were or might be routinely exposed to N. meningitidis cultures

Inclusion criteria for protocol part 2

1. 18 - 65 years of age inclusive;
2. At least 50 kg weight;
3. Blood pressure within the following ranges: Systolic 110-180; Diastolic 60-100;
4. Regular pulse rate (50-90 beats per minute) - exceptions are acceptable upon investigator's judgment;
5. Hematocrit higher than: 32% for women and 35% for males;
6. Visit 3 sera suitable as control for standardization of the SBA as confirmed by the central laboratory.

Exclusion criteria:

1. History of any serogroup B meningococcal vaccine administration
2. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
3. Pregnancy or nursing (breastfeeding) mothers;
4. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least one months prior to study entry;
5. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
6. Receipt of any chronic immunosuppressive therapy
7. Receipt of any chronic immunostimulants
8. Immune deficiency disorder, or known HIV infection
9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
10. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.
11. Any significant chronic infection.
12. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

Exclusion criteria for protocol part 2:

1. Known or suspected autoimmune disease;
2. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, diabetes, cardiovascular, renal, hepatic, immunological, metabolic, urogenital, hematological, gastrointestinal, central nervous system disease);
3. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
4. History of fainting or seizure episodes;
5. Pregnancy
6. Any significant chronic infection;
7. Significant acute infections within the previous 2 weeks;

8. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

   Receipt of any chronic immunosuppressive therapy; Receipt of any chronic immunostimulants; Immune deficiency disorder, or known HIV infection;

9. Significant acute illness within the previous 7 days or body temperature 38.0 C within the previous 3 days;
10. Receipt of systemic antibiotics within the previous 3 days (72 hours).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: rMenB+OMV NZ; Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant meningococcal B (rMenB) + Outer Membrane Vesicle (OMV NZ) vaccine, 2 months apart, in part I of the study, were enrolled for optional blood draws and safety follow-up in part II of the study.

Biological: Recombinant meningococcal B + OMV NZ; 2 injections 2 months apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.	The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.	Day 1 to day 91
Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).	The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs.	Day 92 to day 331

Collaborators and Investigators

• Sponsor: Novartis Vaccines
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Meningococcal Infections
• Other Study ID Numbers: V72_37