Clinical trial NCT04618783: Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization
Official title: Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization Against Multiple Individual Wild and Vaccine-derived Polioviruses, Supplementary Study of a Phase 2 Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poliomyelitis
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 250
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.

Detailed description: This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1).

All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.

Eligibility criteria: Inclusion Criteria:

* Participants of the already finished phase 2 clinical trial;
* Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial;
* Provide written informed consent.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Immunity index of seroconversion rate
timeFrame: One month after three doses of vaccination
Secondary outcomes:
measure: Immunity index of geometric mean titer (GMT)
timeFrame: One month after three doses of vaccination
measure: Immunity index of geometric mean ratio (GMR)
timeFrame: One month after three doses of vaccination
measure: Immunity index of seropositivity rate
timeFrame: One month after three doses of vaccination
Other outcomes:
Locations:
city: Pizhou
country: China
facility: Pizhou Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
name: Yuemei Hu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: