Clinical trial NCT03964012: Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)
Official title: Phase 3, Observer-blind, Randomized, Active Controlled Trial to Assess the Safety of an Investigational Meningococcal Serogroups ACYWX Conjugate Vaccine (NmCV-5) and Compare Its Immunogenicity to a Licensed Meningococcal Serogroups ACYW Conjugate Vaccine (Menactra®), in Healthy Subjects 2 to 29 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Meningitis
Keywords: Neisseria meningitidis
conjugate meningococcal vaccine
Meningococcal serogroup X
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PATH
First posted: 2019-05-28
Enrollment: 1800
Sex: ALL
Minimum age (years): 2
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra.

A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years \& 2-10 years (400 NmCV-5 recipients \& 200 Menactra recipients in each age strata).

Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration.
2. Written informed consent obtained from subjects at least 18 years of age or from their parent/guardian for subjects less than 18 years of age with additional subject assent obtained as appropriate for participating community (i.e. subjects at least 13 years of age in Mali or at least 12 years of age in The Gambia).
3. Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures.
4. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit.
5. Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration

Exclusion Criteria:

1. Acute illness, at the time of study IP administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study IP administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
3. Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years.
4. Current or previous, confirmed disease caused by Neisseria meningitidis.
5. Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration.
6. Known hypersensitivity to any component of the study IPs (i.e., NmCV-5 or Menactra®).
7. History of significant hypersensitivity reactions to any previous vaccine.
8. Administration of any vaccine other than study IPs within 28 days prior to study IP administration or planned administration prior to completion of the study Day 29 visit.
9. Administration of any investigational drug within 30 days prior to study IP administration or planned administration during the study period.
10. Unwilling to avoid (or their child to avoid, if the subject) the ingestion of herbal or other traditional medications during the study period.
11. Administration of immunoglobulin or any blood product within 90 days prior to study IP administration or planned administration during the study period.
12. Administration of immunosuppressants or other immune modifying agents within 90 days prior to study IP administration
13. Administration of systemic antibiotic treatment within 3 days prior to study IP administration.
14. Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, malnutrition, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).
15. Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
16. History of meningitis, seizures, Guillain-Barré syndrome (GBS), or other neurological disorders.
17. History of or family history of congenital or hereditary immunodeficiency.
18. Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
19. Pregnancy
20. Previous inclusion in the study of five immediate family members (i.e., biological father, mother, subject, and brothers and sisters may be included up to a maximum of five members from the same immediate family).

Primary outcomes:
measure: Seroresponse
timeFrame: 28 Days post vaccination
measure: Geometric mean titres
timeFrame: 28 Days post vaccination
Secondary outcomes:
measure: Solicited adverse events
timeFrame: 7 days post vaccination
measure: Unsolicited adverse events
timeFrame: 28 days post vaccination
measure: Serious adverse events (SAEs)
timeFrame: 6 months post vaccination
measure: Seroprotective rSBA titres
timeFrame: 28 days post vaccination
measure: Long term protective rSBA titres
timeFrame: 28 days post vaccination
Other outcomes:
Locations:
city: Fajara
country: Gambia
facility: Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine
city: Bamako
country: Mali
facility: Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
Study officials:
References:
citation: Chen WH, Neuzil KM, Boyce CR, Pasetti MF, Reymann MK, Martellet L, Hosken N, LaForce FM, Dhere RM, Pisal SS, Chaudhari A, Kulkarni PS, Borrow R, Findlow H, Brown V, McDonough ML, Dally L, Alderson MR. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study. Lancet Infect Dis. 2018 Oct;18(10):1088-1096. doi: 10.1016/S1473-3099(18)30400-6. Epub 2018 Aug 14.