Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

NCT03295318 | Completed Phase 2 Results DMC

• 2 other identifiers: ACYWX-002CVIA-058
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet. Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5). The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues. This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®). Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose. The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).

Conditions

Meningitis, Meningococcal

Keywords

Neisseria meningitidis; conjugate meningococcal vaccine; meningococcal serogroup X

Outcome Measures

Primary Outcomes (1)

• Severe Solicited Adverse Event

  Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)

  7 days post each vaccination

Secondary Outcomes (8)

• Seroprotective rSBA Titres

  112 days

• Long Term Protective rSBA Titres

  112 days

• Rise in rSBA Titres

  112 days

• Geometric Mean of rSBA Titres

  112 Days

• Solicited Reactions

  7 days post each vaccination

Study Arms (3)

Adjuvanted study formulation NmCV-5

EXPERIMENTAL

Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.

Biological: Adjuvanted study formulation NmCV-5

Non-adjuvanted study formulation NmCV-5

EXPERIMENTAL

Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.

Biological: Non-adjuvanted study formulation NmCV-5

Menactra

ACTIVE COMPARATOR

Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.

Biological: Menactra

Interventions

Non-adjuvanted study formulation NmCV-5 BIOLOGICAL

Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.

Also known as: MenACYWX

Non-adjuvanted study formulation NmCV-5

Adjuvanted study formulation NmCV-5 BIOLOGICAL

Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine

Also known as: Adj MenACYWX

Adjuvanted study formulation NmCV-5

Menactra BIOLOGICAL

Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.

Also known as: MenACYW-D

Menactra

Eligibility Criteria

• Age: 12 Months - 16 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children between 12 months and 16 months old inclusive (minimum 365 days of age and maximum 16 months plus 29 days of age);
• For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements;
• Who the investigator believes that their parent(s)/ guardian(s) will be available for all the subject visits and would comply with the requirements of the protocol (e.g., timely reporting of adverse events, availability for study site visits and home visits);
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
• Individuals who completed their local infant EPI schedule through 9 months of age (except MenAfriVac dose). A birth dose of OPV is not required)

You may not qualify if:

• History of any meningococcal 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 enrolment.
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
• Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination.
• Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
• Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
• Severe acute malnutrition.
• A family history of congenital or hereditary immunodeficiency.
• History of either hepatitis B or hepatitis C virus infection or human immunodeficiency virus infection.
• Major congenital defects.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed).
• Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
• Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after any study vaccination.
• Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead
• PATH: collaborator

Study Sites (1)

Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251

Bamako, BP251, Mali

Location

Related Publications (1)

• Tapia MD, Sow SO, Naficy A, Diallo F, Haidara FC, Chaudhari A, Martellet L, Traore A, Townsend-Payne K, Borrow R, Hosken N, Smolenov I, Pisal SS, LaForce FM, Dhere RM, Kapse D, Tang Y, Alderson MR, Kulkarni PS. Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers. N Engl J Med. 2021 Jun 3;384(22):2115-2123. doi: 10.1056/NEJMoa2013615.

  PMID: 34077644 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Abhijeet Dharmadhikari
• Organization: Serum Institute of India Pvt. Ltd.

abhijeet.dharmadhikari@seruminstitute.com

+91-20-26602855

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer blind wherein the pharmacist and other study staff involved in vaccine administration will be aware of the treatment allocation. The other study staff involved in safety assessments will be masked to treatment arm. The laboratory involved in immunogenicity analysis will also be blinded to the treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 27, 2017
• Study Start: November 15, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: May 25, 2025
• Results First Posted: September 5, 2021

Record last verified: 2021-08

Locations

MA (1)