A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

NCT02451514 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 2052132016-004420-29V102_02E2
• Study Type: interventional
• Target: 129
• Locations: 3 countries
• Sites: 7

Brief Summary

The purpose of this study is to evaluate persistence of bactericidal antibodies for N. meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years after primary vaccination in subjects who previously received a 2-dose series of MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a 2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive subjects and subjects who previously received one dose of MenACWY

Conditions

Meningococcal Disease; Infections, Meningococcal

Keywords

Antibody persistence; Young Adults; Healthy Adolescents; MenABCWY vaccine; Booster response; MenABCWY+OMV

Outcome Measures

Primary Outcomes (9)

• Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

  The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 2 and 3 and are considered final in Company's judgement.

  At Day 1 (4 years persistence)

• Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

  Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8.

  At Day 1 (4 years persistence)

• Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

  Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

  At Day 1 (4 years persistence)

• Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

  GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

  At Day 1

• Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and B Test Strains.

  The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement.

  At Day 31

• Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

  Immune response against N. meningitidis serogroups A, C, W and Y 30 days after a single dose of MenABCWY+OMV in subjects who previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of subjects with hSBA ≥ 8.

  At Day 31

• Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

  Immune response against N. meningitidis serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

  At Day 31

• Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

  GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

  At Day 31

• Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

  GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

  Day 31 versus Day 1

Secondary Outcomes (20)

• Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

  At Days 1, 4, 8 and 31

• Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

  At Days 1, 31, 34, 38 and 61

• Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

  At Days 1, 4, 8, 31, 34, 38 and 61

• Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

  At Days 1, 4, 8, 31, 34, 38 and 61

• Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

  At Days 1, 4, 8 and 31.

Study Arms (3)

MenABCWY+OMV Group

EXPERIMENTAL

Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.

Biological: MenABCWY+OMV vaccine

MenACWY Group

EXPERIMENTAL

Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.

Biological: MenABCWY+OMV vaccine

Naive Group

EXPERIMENTAL

Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.

Biological: MenABCWY+OMV vaccine

Interventions

MenABCWY+OMV vaccine BIOLOGICAL

Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups.

MenABCWY+OMV Group; MenACWY Group; Naive Group

Eligibility Criteria

• Age: 15 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102\_02E2 (NCT01367158), who received Tdap only in V102\_02E1 (NCT01367158) study and who received no other meningococcal vaccines; Or A proportional number of subjects in each site aged 15 through 23 years on the day of informed consent/assent who did not participate in the V102\_02 (NCT01210885) study and have not previously received any meningococcal vaccine.
• Individuals who / whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
• Individuals who can comply with study procedures including blood draws and follow-up.
• Males Or Females of non-childbearing potential Or Females of childbearing potential who are not pregnant or breastfeeding and who are using an effective birth control method which they have used for at least 30 days prior to study entry, and which they intend to use for at least 30 days after the last study vaccination

You may not qualify if:

• History of any meningococcal vaccine administration (study group C) or History of any meningococcal vaccine administration other than vaccination given in the parent V102\_02 (NCT01210885) study (study groups A and B).
• Progressive, unstable or uncontrolled clinical conditions.
• Hypersensitivity, including allergy, to any component of vac-cines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study.
• Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws.
• Abnormal function of the immune system resulting from:
• a.Clinical conditions.
• Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment.
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Received immunoglobulins or any blood products within 90 days prior to enrollment.
• Received an investigational or non-registered medicinal product within 30 days prior to enrollment.
• Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 14 days from the study vaccines.
• Study personnel as an immediate family or household member.
• Who have experienced a moderate or severe acute infection and/or fever (defined as temperature 38°C) within 3 days prior to enrollment.
• Who have received systemic antibiotic treatment within 3 days prior to enrollment.
• Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Santiago, 8860000, Chile

Location

GSK Investigational Site

Bogotá, 110221, Colombia

Location

GSK Investigational Site

Bogotá, Colombia

Location

GSK Investigational Site

Panama City, 081600383, Panama

Location

GSK Investigational Site

Panama City, 0834 00363, Panama

Location

GSK Investigational Site

Panama City, 0843 01103, Panama

Location

GSK Investigational Site

Panama City, Panama

Location

Related Publications (1)

• Saez-Llorens X, Beltran-Rodriguez J, Novoa Pizarro JM, Mensi I, Keshavan P, Toneatto D. Four-year antibody persistence and response to a booster dose of a pentavalent MenABCWY vaccine administered to healthy adolescents and young adults. Hum Vaccin Immunother. 2018 May 4;14(5):1161-1174. doi: 10.1080/21645515.2018.1457595. Epub 2018 May 9.

  PMID: 29601256 BACKGROUND

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 22, 2015
• Study Start: June 30, 2015
• Primary Completion: November 14, 2015
• Study Completion: December 10, 2015
• Last Updated: July 9, 2020
• Results First Posted: July 9, 2020

Record last verified: 2020-06

Locations

CO (2); PA (4); CL (1)