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

Meningococcal Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226714
• Other study ID #: CTP-MCVF-003
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2024
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: CanSino Biologics Inc.
• Contact: Haojie Liu
• Phone: 022-58213600-6051
• Email: haojie.liu[@]cansinotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 840
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Meningitis

Intervention

Biological:
• MCV4
1 dose of MCV4 on Day 0
• MPSV4
1 dose of MSPV4 on Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CanSino Biologics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects		30 days post immunization
Primary	Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects		30 days post immunization
Primary	Incidence of adverse reactions in all subjects		Within 30 mins after immunization
Primary	Incidence of adverse reactions/events in all subjects		7 days post immunization
Primary	Incidence of adverse reactions/events in all subjects		Within 30 days after immunization
Secondary	Meningococcal antibody positivity for groups A, C, Y, and W135		30 days post immunization
Secondary	Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135		30 days post immunization
Secondary	Antibody titer =1:128 ratio for groups A, C, Y, and W135		30 days post immunization
Secondary	Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects		180 days after immunization
Secondary	GMT for groups A, C, Y, and W135 in selected subjects		180 days after immunization
Secondary	GMI for groups A, C, Y, and W135 in selected subjects		180 days after immunization
Secondary	Antibody titer =1:128 ratio for groups A, C, Y, and W135 in selected subjects		180 days after immunization
Secondary	Incidence of serious adverse events (SAEs) in all subjects		Within 180 days after immunization
Secondary	Incidence of pregnancy events in all subjects		Within 180 days after immunization