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Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964012
Recruitment Status : Active, not recruiting
First Posted : May 28, 2019
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
PATH
Information provided by (Responsible Party):
Serum Institute of India Pvt. Ltd.

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).


Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Biological: NmCV-5 Biological: Menactra Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer blind
Primary Purpose: Prevention
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
Actual Study Start Date : August 20, 2019
Actual Primary Completion Date : February 23, 2020
Estimated Study Completion Date : March 30, 2021


Arm Intervention/treatment
Experimental: NmCV-5

Subjects in this arm will receive polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.

A single dose of 0.5 mL will be administered intramuscularly.

Biological: NmCV-5
Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
Other Name: MenACYWX

Active Comparator: Menactra

Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.

A single dose of 0.5 mL will be administered intramuscularly.

Biological: Menactra
Menactra is available as ready to use solution containing polysaccharide antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine
Other Name: MenACYW-D




Primary Outcome Measures :
  1. Seroresponse [ Time Frame: 28 Days post vaccination ]
    Percentage of subjects with seroresponse, measured by rabbit complement serum bactericidal activity (rSBA) against serogroups A, C, Y, W and X. [Seroresponse is defined as a post-immunization (Day 29) rSBA titer of 32 or greater if the subject's pre-immunization (Day 1) rSBA titer was < 8; or a ≥ four-fold increase over baseline at Day 29 post-immunization if the subject's pre-immunization (Day 1) rSBA titer was ≥ 8].

  2. Geometric mean titres [ Time Frame: 28 Days post vaccination ]
    Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29


Secondary Outcome Measures :
  1. Solicited adverse events [ Time Frame: 7 days post vaccination ]
    Solicited AEs for 7 days following vaccination

  2. Unsolicited adverse events [ Time Frame: 28 days post vaccination ]
    Unsolicited AEs for 28 days following vaccination

  3. Serious adverse events (SAEs) [ Time Frame: 6 months post vaccination ]
    SAEs for 6 months following vaccination

  4. Seroprotective rSBA titres [ Time Frame: 28 days post vaccination ]
    Percentage of subjects with rSBA titer of ≥ 8 against serogroups A, C, Y, W, and X at Day 1 and Day 29

  5. Long term protective rSBA titres [ Time Frame: 28 days post vaccination ]
    Percentage of subjects with rSBA titer of ≥ 128 against serogroups A, C, Y, W, and X at Day 1 and Day 29



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964012


Locations
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Gambia
Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine
Fajara, Gambia
Mali
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
Bamako, Mali, BP251
Sponsors and Collaborators
Serum Institute of India Pvt. Ltd.
PATH
Publications:
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Responsible Party: Serum Institute of India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03964012    
Other Study ID Numbers: ACYWX-03
CVIA 071 ( Other Identifier: PATH )
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Serum Institute of India Pvt. Ltd.:
Neisseria meningitidis
conjugate meningococcal vaccine
Meningococcal serogroup X
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections