Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

NCT00661713 | Completed Phase 2 Results

• 1 other identifier: V72P10
• Study Type: interventional
• Target: 1,631
• Locations: 1 country
• Sites: 10

Brief Summary

The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.

Conditions

Meningococcal Disease

Keywords

Meningococcal disease; Neisseria meningitidis serogroup B; prevention; vaccination; adolescents

Outcome Measures

Primary Outcomes (2)

• Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.

  Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.

  Month-1, 2, 3

• Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination

  Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV

  1 to 7 days after each vaccination

Secondary Outcomes (8)

• Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.

  Month-6 & 7

• Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.

  at baseline, month-1, month-2, month-3, month-6 and month-7.

• Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.

  Month-1, month-2, month-3 and month-7

• Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.

  month-1, month-2, month-3, month-6 and month-7

• Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.

  month-1, month-2, month-3, month-6 and month-7

Study Arms (8)

rMenB06

EXPERIMENTAL

Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

rMenB0

EXPERIMENTAL

Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

rMenB016

EXPERIMENTAL

Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

rMenB01

EXPERIMENTAL

Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

rMenB026

EXPERIMENTAL

Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

rMenB02

EXPERIMENTAL

Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

rMenB012

EXPERIMENTAL

Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

rMenB6

EXPERIMENTAL

Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).

Biological: rMenB+OMV NZ; Biological: Placebo

Interventions

rMenB+OMV NZ BIOLOGICAL

Also known as: Serogroup B Meningococcal Vaccine

rMenB0; rMenB01; rMenB012; rMenB016; rMenB02; rMenB026; rMenB06; rMenB6

Placebo BIOLOGICAL

rMenB0; rMenB01; rMenB012; rMenB016; rMenB02; rMenB026; rMenB06; rMenB6

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• )11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
• )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);
• )in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

You may not qualify if:

• History of any meningococcal B vaccine administration;
• Current or previous, confirmed or suspected disease caused by N. meningitidis;
• Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
• Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
• Antibiotics within 6 days prior to enrollment;
• Pregnancy or nursing (breastfeeding) mothers;
• Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device 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 two months prior to study entry;
• Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
• Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. \[Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed\]; immunostimulants;
• Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
• Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7);
• Participation in another clinical trial within the last 90 days or planned for during study;
• Family members and household members of research staff;
• Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (10)

Site 13: Liceo Diego Aracena de Lo Barnechea

Monseñor Escrivá de Balaguer 14630, Lo Barnechea, Santiago Metropolitan, Chile

Location

Site 41: Colegio Antonio Hermida Fabres

Av. Coronel Alejandro Sepúlveda N° 6801, Chile

Location

Site 43: Liceo José Victorino Lastarria

Av. Miguel Claro N° 32, Chile

Location

Site 51: Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio

Av. Prof Zañartu 1085, Chile

Location

Site 15: Liceo Carmela Carvajal de Prat

Avda. Italia 980, Chile

Location

Site 14: Colegio Parroquial Santa Rosa de Lo Barnechea

Avda. Raúl Labbé Nº 13.799, Chile

Location

Site 42: Centro Educacional Eduardo de la Barra

Calle A, N° 6301, Chile

Location

Site 61: Facultad de Medicina. Universidad de Valparaíso.

Hontaneda # 2653. Valparaíso, Chile

Location

Site 11: Complejo Educacional Eduardo Cuevas Valdés

Lo Barnechea, Chile

Location

Site 12: Colegio San Jose de Lo Barnechea

Santiago, Chile

Location

Related Publications (2)

• 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

• Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Munoz A, Toneatto D, Grana G, Wang H, Clemens R, Dull PM; V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012 Feb 18;379(9816):617-24. doi: 10.1016/S0140-6736(11)61713-3. Epub 2012 Jan 18.

  PMID: 22260988 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

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 20, 2019
• Results First Posted: November 4, 2015

Record last verified: 2019-03

Locations

CL (10)