Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

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

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

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Biological: Rotavirus (Bio Farma) Vaccine; Other: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Klaten, Central Java, Indonesia
      • Gantiwarno Primary Health Center
    • Klaten, Central Java, Indonesia
      • Klaten Selatan Primary Health Center
    • Klaten, Central Java, Indonesia
      • Ngawen Primary Health Center
    • Klaten, Central Java, Indonesia
      • RS Soeradji Tritonegoro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotavirus (Bio Farma) Vaccine-Adult; 1 doses of 1 ml of Rotavirus vaccine per oral	Biological: Rotavirus (Bio Farma) Vaccine; Rotavirus (Bio Farma) Vaccine
Experimental: Rotavirus (Bio Farma) Vaccine-Children; 1 doses of 1 ml of Rotavirus vaccine per oral	Biological: Rotavirus (Bio Farma) Vaccine; Rotavirus (Bio Farma) Vaccine
Experimental: Rotavirus (Bio Farma) Vaccine-Neonates; 3 doses of 1 ml of Rotavirus vaccine per oral	Biological: Rotavirus (Bio Farma) Vaccine; Rotavirus (Bio Farma) Vaccine
Placebo Comparator: Placebo-Neonates; 3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral	Other: Placebo; Placebo contains 30% sucrose in DMEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited symptoms after each immunization	Number of subjects with solicited systemic and gastrointestinal symptoms in the day 0-7 following each dose of investigational product	0-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events of Rotavirus (Bio Farma) vaccine	Number and percentage of subjects with unsolicited Adverse Events (AE) in the day 0-28 following each dose of investigational product	28 days
Serious adverse events of Rotavirus (Bio Farma) vaccine	Number and percentage of subjects with Serious Adverse Events (SAE) within 28 days after each dose of investigational product	28 days
Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group	Number and percentage of subject with adverse event (AE) within 28 days after each dose of investigational product compare to placebo (in neonates group)	28 days
Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group	Number and percentage of subject with Serious Adverse Events (SAE) within 28 days after each dose of investigational product compare to placebo (in neonates group)	28 days
Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination	Deviation in routine hematology and biochemical evaluation	7 days
Excretion of rotavirus in stools in neonates group	Number of neonates with rotavirus excretion in stools	3-7 days
Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing	Subjects with >=3 times increasing antibody from baseline to post investigational product dosing	4-6 weeks after last immunization
Serum anti-rotavirus immunoglobulin (Ig)A following immunization	Serum anti-rotavirus immunoglobulin (Ig)A before and after last immunization	4-6 weeks after last immunization
Serum neutralizing antibody (SNA) following immunization	Serum neutralizing antibody (SNA) before and after last immunization	4-6 weeks after last immunization
Geometric Mean Titer (GMT) following immunization	Geometric mean titer (GMT) before and after last immunization	4-6 weeks after last immunization

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Investigators: Principal Investigator: Jarir At Thobari, Pediatric Research Office (PRO), Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran UGM/RSUP Dr. Sardjito

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): February 18, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RV 0117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No