Clinical trial NCT03902054: Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.
Official title: A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polio and Post-Polio Syndrome
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Beijing Minhai Biotechnology Co., Ltd
First posted: 2019-04-03
Enrollment: 600
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;

Primary outcomes:
measure: The seroconversion rates (SCRs) of each group after three-dose regimen
timeFrame: 28~42 days
measure: The post-immune geometric mean titer (GMT) of each group after three-dose regimen
timeFrame: 28~42 days
measure: The geometric mean fold increase (GMI) of each group after three-dose regimen
timeFrame: 28~42 days
Secondary outcomes:
measure: The incidences of solicited adverse events (AEs) of each group
timeFrame: 7 days
measure: The incidences of unsolicited adverse events (AEs) of each group
timeFrame: 30 days
measure: The incidences of serious adverse events (SAEs) of each group
timeFrame: 30 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Diseases Control and Prevention
state: Jiangsu
Study officials:
References:
citation: 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.