Clinical trial NCT06226714: A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Meningococcal Meningitis
Keywords: Vaccine
Peer controlled
Immunogenicity
Safety
18-59 years
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects
timeFrame: 30 days post immunization
measure: Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects
timeFrame: 30 days post immunization
measure: Incidence of adverse reactions in all subjects
timeFrame: Within 30 mins after immunization
measure: Incidence of adverse reactions/events in all subjects
timeFrame: 7 days post immunization
measure: Incidence of adverse reactions/events in all subjects
timeFrame: Within 30 days after immunization
Secondary outcomes:
measure: Meningococcal antibody positivity for groups A, C, Y, and W135
timeFrame: 30 days post immunization
measure: Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135
timeFrame: 30 days post immunization
measure: Antibody titer ≥1:128 ratio for groups A, C, Y, and W135
timeFrame: 30 days post immunization
measure: Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects
timeFrame: 180 days after immunization
measure: GMT for groups A, C, Y, and W135 in selected subjects
timeFrame: 180 days after immunization
measure: GMI for groups A, C, Y, and W135 in selected subjects
timeFrame: 180 days after immunization
measure: Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 in selected subjects
timeFrame: 180 days after immunization
measure: Incidence of serious adverse events (SAEs) in all subjects
timeFrame: Within 180 days after immunization
measure: Incidence of pregnancy events in all subjects
timeFrame: Within 180 days after immunization
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Jiangjin District Center for Disease Control and Prevention
city: Chongqing
country: China
facility: Wanzhou District Center for Disease Control and Prevention
city: Chongqing
country: China
facility: Yuzhong District Center for Disease Control and Prevention
Study officials:
affiliation: Chongqing Center for Disease Control and Prevention
name: Qing Wang
role: PRINCIPAL_INVESTIGATOR
References: