Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

NCT03902054 | Completed Phase 2

• 1 other identifier: JSVCT042
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60\~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Conditions

Polio and Post-Polio Syndrome

Outcome Measures

Primary Outcomes (3)

• The seroconversion rates (SCRs) of each group 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 post-immune geometric mean titer (GMT) of each group 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 after three-dose regimen

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

  28~42 days

Secondary Outcomes (3)

• The incidences of solicited adverse events (AEs) of each group

  7 days

• The incidences of unsolicited adverse events (AEs) of each group

  30 days

• The incidences of serious adverse events (SAEs) of each group

  30 days

Study Arms (5)

Experimental 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

Biological: Three-dose regimen of high dosage investigational sIPV

Experimental Group - Medium 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 medium dosage investigational sIPV

Biological: Three-dose regimen of medium dosage investigational sIPV

Experimental Group - Low 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 low dosage investigational sIPV

Biological: Three-dose regimen of low dosage investigational sIPV

Control Group -commercialized sIPV

ACTIVE COMPARATOR

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

Biological: Three-dose regimen of commercialized sIPV

Control Group -commercialized IPV

ACTIVE COMPARATOR

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

Biological: Three-dose regimen of commercialized IPV

Interventions

Three-dose regimen of high dosage investigational sIPV BIOLOGICAL

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

Experimental Group - High dosage

Three-dose regimen of medium dosage investigational sIPV BIOLOGICAL

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

Experimental Group - Medium dosage

Three-dose regimen of low dosage investigational sIPV BIOLOGICAL

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

Experimental Group - Low dosage

Three-dose regimen of commercialized sIPV BIOLOGICAL

The control vaccine was manufactured by Chinese Academy of Medical Sciences.

Control Group -commercialized sIPV

Three-dose regimen of commercialized IPV BIOLOGICAL

The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).

Control Group -commercialized IPV

Eligibility Criteria

• Age: 60 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy volunteer aged 2 months (60\~90 days) old 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:

• 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;
• Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Beijing Minhai Biotechnology Co., Ltd: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, 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

Postpoliomyelitis Syndrome

Condition Hierarchy (Ancestors)

Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: December 28, 2017
• Primary Completion: May 26, 2018
• Study Completion: December 28, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

CN (1)