A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 18-59 Years

This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.

Study Overview

• Status: Not yet recruiting
• Conditions: Meningococcal Meningitis
• Intervention / Treatment: Biological: MCV4; Biological: MPSV4

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Haojie Liu; Phone Number: 022-58213600-6051; Email: haojie.liu@cansinotech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18~59 years old at the time of screening.
• Should not have received any meningococcal vaccine in the last 3 years.
• Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
• Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
• Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.

Exclusion Criteria:

• Fever before vaccination, axillary temperature >37.0°C.
• History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
• Volunteers with current meningitis or a history of meningitis.
• Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
• Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
• Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
• Previous vaccination-related hospitalizations or emergencies.
• Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
• Other vaccinations within 14 days.
• Participation in other studies involving interventional studies within 28 days prior to study entry (<28 days) and/or during study participation.
• Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4); Intramuscular injection, 0.5ml	Biological: MCV4; 1 dose of MCV4 on Day 0
Active Comparator: ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4); Subcutaneous iniection, 0.5ml	Biological: MPSV4; 1 dose of MSPV4 on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects	30 days post immunization
Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects	30 days post immunization
Incidence of adverse reactions in all subjects	Within 30 mins after immunization
Incidence of adverse reactions/events in all subjects	7 days post immunization
Incidence of adverse reactions/events in all subjects	Within 30 days after immunization

Secondary Outcome Measures

Outcome Measure	Time Frame
Meningococcal antibody positivity for groups A, C, Y, and W135	30 days post immunization
Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135	30 days post immunization
Antibody titer ≥1:128 ratio for groups A, C, Y, and W135	30 days post immunization
Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects	180 days after immunization
GMT for groups A, C, Y, and W135 in selected subjects	180 days after immunization
GMI for groups A, C, Y, and W135 in selected subjects	180 days after immunization
Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 in selected subjects	180 days after immunization
Incidence of serious adverse events (SAEs) in all subjects	Within 180 days after immunization
Incidence of pregnancy events in all subjects	Within 180 days after immunization

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Investigators: Principal Investigator: Qing Wang, Chongqing Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Peer controlled; 18-59 years
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Neuroinflammatory Diseases; Meningitis, Meningococcal; Meningitis
• Other Study ID Numbers: CTP-MCVF-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No