Clinical trial NCT03462108: Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
Official title: A Prospective Intervention Phase I Study in Three Age De-escalating Group to Assess the Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2018-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Adults and Children Group: Experimental, open labeled, prospective intervention study
* Neonates Group: Experimental, randomized, double blind, prospective intervention study
Primary purpose: PREVENTION

Brief summary: This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.

Detailed description: To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.

Eligibility criteria: Inclusion Criteria for Adults:

* Healthy Adults as determined by clinical judgment, including a medical history, physical exam and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
* Subjects have been informed properly regarding the study and signed the informed consent form.
* Subject will commit to comply with the instructions of the investigator and the schedule of the trial.

Inclusion Criteria for Children:

* Healthy Children as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
* Parents/guardian(s) have been informed properly regarding the study and signed the informed consent form
* Parent/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Inclusion Criteria for Neonates:

* Neonate 0-5 days of age at the time of first dose, with cord blood available
* Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
* The neonate was born full term (minimum of 36 completed weeks and maximum of 42 completed weeks gestation).
* Neonate birth weight 2500-4000 g inclusive.
* Parents or guardians have been informed properly regarding the study and signed the informed consent form
* Parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria for Adults:

* Subject concomitantly enrolled or scheduled to be enrolled in another trial
* Any direct relatives relationship with the study team.
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
* Known history of allergy to any component of the vaccines
* Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
* Gastroenteritis in the 24 hours preceding enrollment.
* History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
* Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant).
* Subject consuming or expect to consume a probiotics within one week before and after vaccination
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
* Pregnancy \& lactation (Adults).
* Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
* Subject planning to move from the study area before the end of study period.

Exclusion Criteria for Children:

* Subject concomitantly enrolled or scheduled to be enrolled in another trial
* Any direct relatives relationship with the study team
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C ) within the 48 hours preceding enrollment
* Known history of allergy to any component of the vaccines
* Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
* Gastroenteritis in the 24 hours preceding enrollment.
* Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception.
* History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
* Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant).
* Subjects consuming or expect to consume a probiotics within one week before and after vaccination.
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
* Individuals who have previously received any rotavirus vaccine.
* Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
* Subject planning to move from the study area before the end of study period

Exclusion Criteria for Neonates:

* Subject concomitantly enrolled or scheduled to be enrolled in another trial.
* Any direct relatives relationship with the study team.
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
* Subject with known or suspected history of allergy to any component of the vaccines.
* Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) infection.
* Subject with known or suspected major congenital malformations or genetically determined disease.
* Subject with intussusception.
* Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
* Subject with a known or suspected disease of the immune system or those who has received immunosuppresive therapy, including immunosuppresive courses of systemic corticosteroid.
* Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of study.
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
* Subject immunized with non- EPI vaccines.
* Gastroenteritis in the 24 hours preceding enrollment.
* Subject planning to move from the study area before the end of study period.

Primary outcomes:
measure: Solicited symptoms after each immunization
timeFrame: 0-7 days
Secondary outcomes:
measure: Adverse events of Rotavirus (Bio Farma) vaccine
timeFrame: 28 days
measure: Serious adverse events of Rotavirus (Bio Farma) vaccine
timeFrame: 28 days
measure: Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group
timeFrame: 28 days
measure: Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group
timeFrame: 28 days
measure: Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination
timeFrame: 7 days
measure: Excretion of rotavirus in stools in neonates group
timeFrame: 3-7 days
measure: Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing
timeFrame: 4-6 weeks after last immunization
measure: Serum anti-rotavirus immunoglobulin (Ig)A following immunization
timeFrame: 4-6 weeks after last immunization
measure: Serum neutralizing antibody (SNA) following immunization
timeFrame: 4-6 weeks after last immunization
measure: Geometric Mean Titer (GMT) following immunization
timeFrame: 4-6 weeks after last immunization
Other outcomes:
Locations:
city: Klaten
country: Indonesia
facility: Gantiwarno Primary Health Center
state: Central Java
city: Klaten
country: Indonesia
facility: Klaten Selatan Primary Health Center
state: Central Java
city: Klaten
country: Indonesia
facility: Ngawen Primary Health Center
state: Central Java
city: Klaten
country: Indonesia
facility: RS Soeradji Tritonegoro
state: Central Java
Study officials:
affiliation: Pediatric Research Office (PRO), Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran UGM/RSUP Dr. Sardjito
name: Jarir At Thobari
role: PRINCIPAL_INVESTIGATOR
References: