Clinical trial NCT02451514: 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)
Official title: A Phase 2, Open-label, Controlled, Multi-center Extension 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Infections, Meningococcal
Keywords: Antibody persistence
Young Adults
Healthy Adolescents
MenABCWY vaccine
Booster response
MenABCWY+OMV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-05-22
Enrollment: 129
Sex: ALL
Minimum age (years): 15
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Subjects will be randomised into two different blood draw schedules according to a 1:1 ratio

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Individuals who can comply with study procedures including blood draws and follow-up.
4. 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

Exclusion Criteria:

1. 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).
2. Progressive, unstable or uncontrolled clinical conditions.
3. Hypersensitivity, including allergy, to any component of vac-cines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study.
4. Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws.
5. Abnormal function of the immune system resulting from:

   a.Clinical conditions.
6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment.
7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Received immunoglobulins or any blood products within 90 days prior to enrollment.
9. Received an investigational or non-registered medicinal product within 30 days prior to enrollment.
10. 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.
11. Study personnel as an immediate family or household member.
12. Who have experienced a moderate or severe acute infection and/or fever (defined as temperature 38°C) within 3 days prior to enrollment.
13. Who have received systemic antibiotic treatment within 3 days prior to enrollment.
14. 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.

Primary outcomes:
measure: Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Day 1 (4 years persistence)
measure: Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
timeFrame: At Day 1 (4 years persistence)
measure: Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
timeFrame: At Day 1 (4 years persistence)
measure: Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Day 1
measure: Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and B Test Strains.
timeFrame: At Day 31
measure: Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
timeFrame: At Day 31
measure: Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
timeFrame: At Day 31
measure: Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Day 31
measure: Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: Day 31 versus Day 1
Secondary outcomes:
measure: Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Days 1, 4, 8 and 31
measure: Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Days 1, 31, 34, 38 and 61
measure: Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
timeFrame: At Days 1, 4, 8, 31, 34, 38 and 61
measure: Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
timeFrame: At Days 1, 4, 8, 31, 34, 38 and 61
measure: Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Days 1, 4, 8 and 31.
measure: Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Days 1, 31, 34, 38 and 61
measure: GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Days 4, 8 and 31 versus Day 1.
measure: GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Days 31, 34, 38 and 61 versus Day 1.
measure: Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Day 61
measure: Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
timeFrame: At Day 61
measure: Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
timeFrame: At Day 61
measure: GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: At Day 61
measure: GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
timeFrame: Day 61 versus Day 1 (baseline)
measure: Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination
timeFrame: Within 30 min after each vaccination
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: From Day 1 (6 hours) to Day 7 after each vaccination
measure: Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data
timeFrame: From Day 1 (6 hours) to Day 7 after each vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
measure: Number of Subjects With Medically Attended AEs Reported During the Entire Study Period.
timeFrame: During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
measure: Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period.
timeFrame: From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)
measure: Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period.
timeFrame: During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Panama City
country: Panama
facility: GSK Investigational Site
city: Panama City
country: Panama
facility: GSK Investigational Site
city: Panama City
country: Panama
facility: GSK Investigational Site
city: Panama City
country: Panama
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.