meningococcal groups ACYWX conjugate vaccine (NmCV-5) / PATH, Serum Institute of India - LARVOL DELTA

Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (clinicaltrials.gov) - P3 | N=1325 | Completed | Sponsor: Emory University | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Feb 2025

Trial completion • Trial completion date • CNS Disorders • Infectious Disease • Meningococcal Infections

Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, W, Y, and X when co-administered with routine childhood vaccines at ages 9 months and 15 months in Mali: a single-centre, double-blind, randomised, controlled, phase 3, non-inferiority trial. (PubMed, Lancet) - P3 | "When compared with a licensed, quadrivalent meningococcal conjugate vaccine, and given alongside other routine vaccines, a single dose of NmCV-5 was safe and elicited a non-inferior immune response in infants aged 9 months and young children aged 15 months."

Head-to-Head • Journal • P3 data • CNS Disorders • Infectious Disease • Measles • Meningococcal Infections • Rubella

A perspective on the novel pentavalent Men5CV (NmCV-5) meningitis vaccine and Nigeria's pioneering rollout campaign. (PubMed, Infez Med) - "Funding from organizations like Gavi, the Vaccine Alliance, highlights the importance of coordinated international efforts aligned with the WHO's roadmap for meningitis elimination by 2030. Stakeholder involvement, extensive immunization campaigns, and a strong healthcare infrastructure are all practical recommendations for public health integration."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Infectious Disease • Meningococcal Infections • Pain

A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine. (PubMed, NPJ Vaccines) - P1 | "A randomized, active-controlled, double-blind, first-in-human, phase 1 study was conducted in healthy Korean adults to evaluate the safety, tolerability, and immunogenicity of EuNmCV-5, a new pentavalent meningococcal vaccine targeting serogroups A, C, W, X, and Y. Sixty participants randomly received a single dose of either EuNmCV-5 or MenACWY-CRM, a quadrivalent vaccine containing serogroups A, C, W, and Y. Safety was assessed through monitoring anaphylactic reactions, adverse events for 28 days, and serious adverse events over 180 days...The seroprotection rates exceeded 96.7%, and the seroconversion rates were over 85% for all the targeted serogroups. It showed higher seroconversion rates against serogroups A and C (p = 0.0016 and 0.0237, respectively) and elicited a substantial increase in GMT for all targeted serogroups compared to the MenACWY-CRM.ClinicalTrials.gov identifier: NCT05739292."

Journal • Infectious Disease • Meningococcal Infections

Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: EuBiologics Co.,Ltd | Active, not recruiting ➔ Completed | Trial primary completion date: Oct 2023 ➔ May 2023

Trial completion • Trial primary completion date • Infectious Disease • Meningococcal Infections

Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia. (PubMed, N Engl J Med) - P3 | "For all four serotypes in common with the MenACWY-D vaccine, the NmCV-5 vaccine elicited immune responses that were noninferior to those elicited by the MenACWY-D vaccine. NmCV-5 also elicited immune responses to serogroup X. No safety concerns were evident. (Funded by the U.K. Foreign, Commonwealth, and Development Office and others; ClinicalTrials.gov number, NCT03964012.)."

Journal • CNS Disorders • Infectious Disease • Meningococcal Infections

Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: EuBiologics Co.,Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections

Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (clinicaltrials.gov) - P3 | N=1320 | Active, not recruiting | Sponsor: Emory University | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2023 ➔ Apr 2023

Enrollment closed • Trial primary completion date • CNS Disorders • Infectious Disease • Meningococcal Infections

Validation and use of a serum bactericidal antibody assay for Neisseria meningitidis serogroup X in a seroprevalence study in Niger, West Africa. (PubMed, Vaccine) - "The objective of the study was to provide an overview of natural immunity to serogroup X within a community in the African meningitis belt prior to the introduction of a pentavalent conjugate vaccine (NmCV-5)...The SBA assay was successfully validated for selectivity/specificity, precision/reproducibility, linearity, and stability. This study demonstrated the suitability of the serogroup X SBA assay in clinical trials for future meningococcal conjugate vaccines containing serogroup X polysaccharides."

Journal • CNS Disorders • Infectious Disease • Meningococcal Infections

Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (clinicaltrials.gov) - P3 | N=1320 | Recruiting | Sponsor: Emory University | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Infectious Disease • Meningococcal Infections

Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (clinicaltrials.gov) - P3; N=1320; Not yet recruiting; Sponsor: Emory University

Clinical • New P3 trial • CNS Disorders • Infectious Disease • Meningococcal Infections

ACYWX-04: Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age (clinicaltrials.gov) - P2/3; N=1640; Completed; Sponsor: Serum Institute of India Pvt. Ltd.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ Mar 2021

Clinical • Trial completion • Trial completion date • Infectious Disease • Meningococcal Infections

Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use. (PubMed, Pathogens) - "Lot-to-lot manufacturing consistency was also demonstrated in preclinical studies for polysaccharide-specific IgG and complement-dependent serum bactericidal activity for each serogroup. This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India."

Clinical • Journal • CNS Disorders • Infectious Disease • Meningococcal Infections • Tetanus

Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) (clinicaltrials.gov) - P3; N=1800; Completed; Sponsor: Serum Institute of India Pvt. Ltd.; Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Infectious Disease • Meningococcal Infections

Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers. (PubMed, N Engl J Med) - P2 | "No safety concerns were identified with two doses of NmCV-5. A single dose of NmCV-5 elicited immune responses that were similar to those observed with two doses of MenACWY-D. Adjuvanted NmCV-5 provided no discernible benefit over nonadjuvanted NmCV-5. (Funded by the U.K. Foreign, Commonwealth, and Development Office; ClinicalTrials.gov number, NCT03295318.)."

Journal • Infectious Disease • Meningococcal Infections

ACYWX-04: Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age (clinicaltrials.gov) - P2/3; N=1640; Active, not recruiting; Sponsor: Serum Institute of India Pvt. Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2022 ➔ Dec 2021; Trial primary completion date: Jun 2020 ➔ Mar 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) (clinicaltrials.gov) - P3; N=1800; Active, not recruiting; Sponsor: Serum Institute of India Pvt. Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease

Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) (clinicaltrials.gov) - P3; N=1800; Recruiting; Sponsor: Serum Institute of India Pvt. Ltd.; Trial completion date: Jun 2020 ➔ Mar 2021

Clinical • Trial completion date

Serogroup A meningococcal conjugate vaccines: building sustainable and equitable vaccine strategies. (PubMed, Expert Rev Vaccines) - "Further, the development of a new multi-serogroup meningococcal conjugate vaccine (NmCV-5) that includes serogroup A is highlighted. The PubMed database (1996-2019) was searched for studies relating to MenA outbreaks, vaccine, and immunization strategies; and the Neisseria PubMLST database of 1755 MenA isolates (1915-2019) was reviewed.Expert opinion: Using strategies from the successful MenAfriVac campaign, expanded collaborative partnerships have been built to develop and implement (anticipated 2023) a novel, low-cost multivalent component meningococcal vaccine that includes serogroup A. This vaccine promises greater sustainability and is directed toward global control of meningococcal disease in the African meningitidis belt and beyond. The new WHO global roadmap addresses the continuing problem of bacterial meningitis, including meningococcal vaccine prevention, and provides a framework for further reducing the devastation of MenA and other acute bacterial meningitis..."

Journal • Immunology • Infectious Disease

ACYWX-04: Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age (clinicaltrials.gov) - P2/3; N=1640; Recruiting; Sponsor: Serum Institute of India Pvt. Ltd.

Clinical • New P2/3 trial • Infectious Disease