Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

NCT ID: NCT03902054

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-28
• Study Completion Date: 2018-12-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental Group - High dosage

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

Group Type: EXPERIMENTAL

Three-dose regimen of high dosage investigational sIPV

Intervention Type: BIOLOGICAL

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

Experimental Group - Medium dosage

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

Group Type: EXPERIMENTAL

Three-dose regimen of medium dosage investigational sIPV

Intervention Type: BIOLOGICAL

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

Experimental Group - Low dosage

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

Group Type: EXPERIMENTAL

Three-dose regimen of low dosage investigational sIPV

Intervention Type: BIOLOGICAL

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

Control Group -commercialized sIPV

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

Group Type: ACTIVE_COMPARATOR

Three-dose regimen of commercialized sIPV

Intervention Type: BIOLOGICAL

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

Control Group -commercialized IPV

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

Group Type: ACTIVE_COMPARATOR

Three-dose regimen of commercialized IPV

Intervention Type: BIOLOGICAL

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

Interventions

Three-dose regimen of high dosage investigational sIPV

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

Intervention Type: BIOLOGICAL

Three-dose regimen of medium dosage investigational sIPV

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

Intervention Type: BIOLOGICAL

Three-dose regimen of low dosage investigational sIPV

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

Intervention Type: BIOLOGICAL

Three-dose regimen of commercialized sIPV

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

Intervention Type: BIOLOGICAL

Three-dose regimen of commercialized IPV

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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;

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Minhai Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32867698 (View on PubMed)

Other Identifiers

JSVCT042

Identifier Type: -

Identifier Source: org_study_id