Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

Phase 2

Completed

• Conditions: Meningococcal Meningitis; Meningococcal Disease
• Interventions: Biological: rMenB+OMV-NZ; Biological: No Vaccine

• Registration Number: NCT01148524
• Lead Sponsor: Novartis Vaccines

Brief Summary

This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713).

Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Study Start: 2010-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-12-11
• Results First Submitted QC: 2014-02-07
• Results First Posted: 2014-03-11
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 817

Inclusion Criteria

Informed consent was obtained from all the subjects before enrollment into the study after the nature of the study had been explained.

Inclusion criteria for naive subjects, newly enrolled:

1. Healthy adolescents, 13-19 years of age (the age window is defined as the first day the subject turns 13 years of age up to the day before the subject turns 20 years of age).

2. For Minor subjects:

   • subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.

   For Adult subjects:

   • subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.

3. Were available for the visit scheduled in the study.

4. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.

Inclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):

1. For Minor subjects: (≤18 years of age)

   • subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.

   For Adult subjects: (older than 18 years of age)

   • subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.

2. Who had participated in the V72P10 study and had received their last vaccination 18 months (-30 + 90 days) before enrollment in V72P10E1.

3. Who had completed the vaccination course in study V72P10, according to the protocol.

4. Who had provided at least the blood sample one month after the last vaccination in V72P10 (blood sample at visit 6, month 7), according to the protocol.

5. Were available for the study visit scheduled in the study.

6. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.

Exclusion Criteria

Exclusion criteria for naïve subjects newly enrolled:

1. For Minor subjects:

   • subjects who were unwilling or unable to give written informed assent to participate in the study, and whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study

   For Adult subjects:

   • subjects who were unwilling or unable to give written informed consent to participate in the study.

2. History of any meningococcal B vaccine administration.

3. Previous ascertained or suspected disease caused by N. meningitidis.

4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.

5. Antibiotic treatment within 6 days prior to enrollment.

6. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).

7. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion);

8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.

9. Participation in another clinical trial within 90 days prior to enrollment or planned for during study.

10. Family members and household members of study staff.

11. Any condition which, in the opinion of the investigator, could have interfered with the evaluation of the study objectives.

Exclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):

Exclusion criteria were the same as for naïve subjects, with the exception of criterion 2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rMenB0	rMenB+OMV-NZ	Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study had a blood draw.
rMenB02	rMenB+OMV-NZ	Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study had a blood draw.
rMenB012	rMenB+OMV-NZ	Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and 1 dose of placebo (at 6 months) in V72P10 study had a blood draw.
rMenB06	rMenB+OMV-NZ	Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study had a blood draw.
rMenB026	rMenB+OMV-NZ	Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study had a blood draw.
rMenB6	rMenB+OMV-NZ	Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study had a blood draw.
rMenB01	rMenB+OMV-NZ	Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 month) and placebo (at 2 and 6 months) in V72P10 study had a blood draw.
rMenB016	rMenB+OMV-NZ	Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study had a blood draw.
Naive	No Vaccine	An additional study group of naïve subjects that served as a baseline comparator for assessing antibody persistence in the vaccine groups and had blood draw for serological analyses at the time of enrollment.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.	month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.	The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.	month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.	The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.	month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.	The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.
Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.	18 months after last vaccination V72P10 study.	The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.

Trial Locations

Locations (6)

Centro de Salud Lo Barnechea; 🇨🇱 Santiago, Chile

Liceo Jose Victorino Lastarria; 🇨🇱 Santiago, Chile

Universidad de Chile. Facultad de Medicina; 🇨🇱 Santiago, Chile

Escuela de Medicina de la Universidad de Valparaíso; 🇨🇱 Santiago, Chile

Centro para vacunas en desarrollo. Hospital de Niños Roberto del Río; 🇨🇱 Santiago, Chile

Hospital Luis Calvo Mackenna; 🇨🇱 Santiago, Chile