Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization

Sinovac

Status: Completed

Conditions: Poliomyelitis

Treatments: Biological: Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses; Biological: Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses; Biological: Three doses of control wIPV, vaccinated within one-month interval between doses; Biological: Three doses of control sIPV, vaccinated within one-month interval between doses; Biological: Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04618783

PRO-sIPV-1001-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 2 to 2 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 5 patient groups

Low-dosage experimental group

Experimental group

Description:

Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses

Treatment:

Biological: Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses

Medium-dosage experimental group

Experimental group

Description:

Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses

Treatment:

Biological: Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses

High-dosage experimental group

Experimental group

Description:

Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses

Treatment:

Biological: Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses

Control wIPV group

Active Comparator group

Description:

Three doses of control wIPV, vaccinated within one-month interval between doses

Treatment:

Biological: Three doses of control wIPV, vaccinated within one-month interval between doses

Control sIPV group

Active Comparator group

Description:

Three doses of control sIPV, vaccinated within one-month interval between doses

Treatment:

Biological: Three doses of control sIPV, vaccinated within one-month interval between doses