Meningococcal Disease, Meningococcal Meningitis
Conditions
Keywords
Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults
Brief summary
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.
Interventions
BIOLOGICALRecombinant meningococcal B + OMV NZ
2 injections 2 months apart
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | Day 1 to 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. |
| 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). | Day 92 to day 331 | 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. |
Countries
Italy
Participant flow
Recruitment details
Subjects were recruited from a single center.
Pre-assignment details
All enrolled subjects participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study.
In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Visit 1-Visit 3 (Day 0-91) - Part I | Lost to Follow-up | 1 |
| Visit 4-Visit 7 (Day 151-331) - Part II | Lost to Follow-up | 4 |
| Visit 4-Visit 7 (Day 151-331) - Part II | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | rMenB+OMV NZ |
|---|---|
| Age, Customized rMenB (part II; N=11) | 34.1 years STANDARD_DEVIATION 5.6 |
| Age, Customized rMenB (part I; N=18) | 34.5 years STANDARD_DEVIATION 5.7 |
| Sex/Gender, Customized rMenB( part I; female) | 13 subjects |
| Sex/Gender, Customized rMenB( part II; female) | 8 subjects |
| Sex/Gender, Customized rMenB( part II; male) | 3 subjects |
| Sex/Gender, Customized rMenB( part I; male) | 5 subjects |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
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.
Time frame: Day 1 to day 91
Population: This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part one of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | SAEs | 0 subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | Medically attended AEs | 2 subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | At least possibly related medically | 0 subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | At least possibly related SAEs | 0 subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. | Premature withdrawals due to AEs | 0 subjects |
Primary
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.
Time frame: Day 92 to day 331
Population: This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part two of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | 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). | All AEs | 0 subjects |
| rMenB+OMV NZ | 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). | SAEs | 0 subjects |
| rMenB+OMV NZ | 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). | At least possibly related SAEs | 0 subjects |