A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers

ConditionPoliomyelitis

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age6-18

SponsorCanSino Biologics Inc.

About this trial

This is a phase I/II randomized, double-blind, and positive-controlled study. Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio (Dose H) or control vaccine in a ratio of 3:1. The phase I infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Phase II infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Each infant participant will be administrated 3 doses of the assigned vaccine with 28 days apart, and the booster dose will be given when the infant is 12-18 months old. Enrollment of Phase I and Phase II will be staggered in descending order of age group but ascending order of dosing levels. Blood and mucosal samples will be collected for immunogenicity evaluation over the time course of the study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy toddlers aged 12-18 months at the time of screening, and have completed primary immunization of polio vaccine according to the national government program in the first year of life.

Healthy infants aged 6 weeks to 2 months (42 to 98 days, with the day of birth considered day of life 1), and who have not received any polio vaccines.

Able to obtain written informed consent from parent(s) or legal guardian(s).

Participants and their parents or legal guardian(s) can comply with trial procedures, are available for the duration of follow-up, and have a suitable telephone contact available.

Disqualifiers

Current polio disease or history of polio disease.

Toddlers who have an interval of less than 5 months since their last dose of the polio vaccine.

Infants born at < 37 weeks of gestation.

Children with a birth weight < 2500g and a body weight < 3500g at the time of enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose
Biological/Vaccine
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
VLP-Polio medium dose
Biological/Vaccine
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
VLP-Polio high dose
Biological/Vaccine
1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Vaccine Poliomyelitis Inactivated (IPV)
Biological/Vaccine
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants

Treatment groups

480 Participants

are divided into 14 treatment groups

Treatment groups

See each treatment group below.

Group A: Phase I, Toddler Group A, Experimental vaccine, High dose, IMExperimental treatment 1 intervention

Group B: Phase I, Toddler Group A, Control vaccine, IMActive comparator 1 intervention

Group C: Phase I, Infant Group B, Experimental vaccine, Low-adjuvant dose, IMExperimental treatment 1 intervention

Group D: Phase I, Infant Group B, Control vaccine, IMActive comparator 1 intervention

Group E: Phase I, Infant Group C, Experimental vaccine, Medium dose, IMExperimental treatment 1 intervention

Group F: Phase I, Infant Group C, Control vaccine, IMActive comparator 1 intervention

Group G: Phase I, Infant Group D, Experimental vaccine, High dose, IMExperimental treatment 1 intervention

Group H: Phase I, Infant Group D, Control vaccine, IMActive comparator 1 intervention

Group I: Phase II, Infant Group E, Experimental vaccine, Low-adjuvant dose, IMExperimental treatment 1 intervention

Group J: Phase II, Infant Group E, Control vaccine, IMActive comparator 1 intervention

Group K: Phase II, Infant Group F, Experimental vaccine, Medium dose, IMExperimental treatment 1 intervention

Group L: Phase II, Infant Group F, Control vaccine, IMActive comparator 1 intervention

Group M: Phase II, Infant Group G, Experimental vaccine, High dose, IMExperimental treatment 1 intervention

Group N: Phase II, Infant Group G, Control vaccine, IMActive comparator 1 intervention

Trial outcomes

Primary outcomes

Phase I: Percentage of participants with solicited adverse events (AEs)

Time frame

Within 7 days after each vaccination

Phase II: Percentage of participants with solicited adverse events (AEs)

Time frame

Within 7 days after each vaccination

Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3

Time frame

Day 0 before vaccination and on Day 28 after the 3rd dose vaccination

Secondary outcomes

Phase I: Percentage of participants with unsolicited AEs

Time frame

Within 28 days after each vaccination

Phase I: Percentage of participants with solicited AEs

Time frame

Within 30 minutes after each vaccination

Phase I: Percentage of participants experiencing serious adverse events (SAEs)

Time frame

Through study completion, Toddlers about 6 months, Infant about 20-22 months.

Phase I: Geometric mean titer (GMT) of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers

Time frame

Day 0 before vaccination and on Day 28 after the vaccination

Other outcomes

Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.

Time frame

Day 0 before booster vaccination, on Day 28 and Month 6 after the booster vaccination

Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.

Time frame

Day 0 before booster vaccination, on Day 28 and Month 6 after the booster vaccination

Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.

Time frame

Day 0 before booster vaccination, on Day 28 and Month 6 after the booster vaccination

Phase II: GMT of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in stool samples in extended immunogenicity subgroup participants

Time frame

Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CanSino Biologics Inc.

Lead sponsor

Source ClinicalTrials.gov

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