Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib)

NCT04264546 | Completed Phase 1

• 1 other identifier: 2017L00935-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18\~45 years and 20 children aged 4 years were only administered one dose of sIPV with high D antigen content. 20 infants aged 2 months (60\~90 days) were administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Conditions

Polio

Outcome Measures

Primary Outcomes (3)

• The seroconversion rates (SCRs) of each group 30 days after three-dose regimen

  Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.

  28~42 days

• The geometric mean titer (GMT) of each group 30 days after three-dose regimen

  GMT of each group 28\~42 days after three-dose regimen

  28~42 days

• The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen

  The GMI is the increase of post-immune GMT from pre-immune GMT

  28~42 days

Secondary Outcomes (2)

• The incidences of adverse reactions of each group occurred within 30 days after each injection

  30 days

• The incidences of adverse events (AEs) of each group occurred within 30 days after each injection

  30 days

Study Arms (3)

Experimental Adult Group - High dosage

EXPERIMENTAL

One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of high dosage investigational sIPV Intervention: Biological: one-dose regimen of high dosage investigational sIPV

Biological: sIPV

Experimental Children Group - High dosage

EXPERIMENTAL

One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of high dosage investigational sIPV Intervention: Biological: one-dose regimen of high dosage investigational sIPV

Biological: sIPV

Experimental Infant Group - High dosage

EXPERIMENTAL

Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV Intervention: Biological: Three-dose regimen of high dosage investigational sIPV

Biological: sIPV

Interventions

sIPV BIOLOGICAL

The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.

Experimental Adult Group - High dosage; Experimental Children Group - High dosage; Experimental Infant Group - High dosage

Eligibility Criteria

• Age: 60 Days - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy volunteer aged 18\~45 years with/without prior vaccination of poliovirus and without any contraindication for vaccination;
• Healthy volunteer aged 4 years with/without prior vaccination of poliovirus but without booster vaccination and any contraindication for vaccination;
• Healthy volunteer aged 2 months (60\~90 days) without prior vaccination of poliovirus and any contraindication for vaccination;
• Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
• Complying with the requirement of the study protocol;
• Axillary temperature ≤ 37.0 °C;

You may not qualify if:

• Women aged 18\~45 years with positive urine pregnancy test, pregnant or lactating women, or women with pregnancy plans within 3 months;
• Preterm or low birth weight infants;
• Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
• History of polio;
• Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
• History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
• Autoimmune disease or immunodeficiency/immunosuppressive;
• Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder), or significant bruising or coagulopathy;
• Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
• Mother of the participant has HIV infection;
• Acute illness or acute exacerbation of chronic disease within the past 7 days;
• Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
• Receipt of any subunit or inactivated vaccine within the past 7 day;
• Receipt of any live attenuated vaccine within the past 14 days;
• Receipt of any blood product within the past 3 months;

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, China

Location

Related Publications (1)

• Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1.

  PMID: 32867698 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Fengcai Zhu, Master

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 11, 2020
• Study Start: November 24, 2017
• Primary Completion: March 9, 2018
• Study Completion: December 28, 2018
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

CN (1)