Clinical trial NCT02985320: Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
Official title: A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Poliomyelitis
Keywords: Sabin strain
Inactivated poliovirus vaccine
poliomyelitis
safety
immunogenicity
infant
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 708
Sex: ALL
Minimum age (years): 2
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

Detailed description: This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
* Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
* Proven legal identity;
* Participants (≥ 18 years old), or guardians of the participants (\< 18 years old) 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:

* Breast feeding, pregnant, or expected to conceive in the next 60 days;
* 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;
* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
* Autoimmune disease or immunodeficiency/immunosuppressive;
* serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
* severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
* Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
* Long term history of alcoholism or drug abuse;
* Receipt of any of the following products:

  1. Any subunit or inactivated vaccine within the past 7 day;
  2. Any live attenuated vaccine within the past 14 days;
  3. Any other investigational medicine(s) within the past 30 days;
  4. Any blood product within the past 3 months;
  5. Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
* Acute illness or acute exacerbation of chronic disease within the past 7 days;
* Axillary temperature \> 37.0 °C;
* Infant participants with prior vaccination of poliovirus;
* 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 of the phase II trial after three-dose regimen
timeFrame: 90 days
measure: The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
timeFrame: 90 days
measure: The geometric mean fold increase (GMI) of each group after three-dose regimen
timeFrame: 90 days
Secondary outcomes:
measure: The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
timeFrame: 7 days
measure: The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
timeFrame: 30 days
measure: The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
timeFrame: 30 days
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Pizhou City Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
name: Yuemei Hu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, Hu Y. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: A phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782-6789. doi: 10.1016/j.vaccine.2018.09.023. Epub 2018 Sep 21.