- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434770
Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
A Phase III Single-blind, Randomized, Controlled Study in Healthy Kenyan Infants to Assess the Immunogenicity and Safety of Beijing TiantanBio Liquid Bivalent Oral Poliomyelitis Vaccine (bOPV) in Comparison to a WHO Prequalified Comparator bOPV
Study Overview
Status
Conditions
Detailed Description
BBIBP has been one of the two suppliers of trivalent oral polio vaccine (tOPV) in China since 1985, with control of polio in China evidence of the effectiveness of its vaccine. The company plans to introduce a liquid formulation of bOPV (types 1 and 3) to meet increasing global demand with the phasing-out of tOPV. The proposed study is intended to provide data sufficient to obtain World Heath Organization (WHO) prequalification for the BBIBP bOPV, thus making the vaccine available to help meet global demand.
Infants were enrolled and randomized prior to the birth dose of bOPV. The first dose of study vaccine was administered during the first two weeks of life and then co-administered with the primary Expanded Programme on Immunization (EPI) series vaccines in Kenya at 6, 10 and 14 weeks of age. The Kenya EPI schedule includes the following additional vaccines:
- Bacille Calmette-Guérin Vaccine (BCG) at birth
- Diphtheria and Tetanus Toxoid with Whole Cell Pertussis, Haemophilus influenzae Type V vaccine (Hib), and Hepatitis B Vaccine (DTwPHibHep) at 6, 10, 14 weeks;
- Pneumococcal Conjugate vaccine (PCV) at 6, 10, 14 weeks
- Rotavirus vaccine (Rotarix) at 6, 10 weeks
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Kericho, Kenya
- Kenya Medical Research Institute (KEMRI)/Walter Reed Project
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Nyanza
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Kisumu, Nyanza, Kenya, PO Box 54-40100
- Kenya Medical Research Institute/Walter Reed Project
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, full-term infants, as established by medical history and clinical examination before entering into the study.
- Parents willing to provide written informed consent.
- Age: infants less than 2 weeks of age at the time of enrollment (from the 1st through the 14th day of life, inclusive)
Exclusion Criteria:
- Birth weight (as documented at first medical contact) less than 2.5 kg
- Presence of diarrhea or vomiting in the previous 24 hours or on the day of enrollment (temporary exclusion)
- Presence of fever (> 37.5°C) on the day of enrollment (temporary exclusion)
- Acute disease at the time of enrollment (temporary exclusion)
- Significant malnutrition as per Investigator's judgment
- Concurrent participation in another clinical study at any time during the study period in which the infant will be exposed to an investigational or a non-investigational product
- Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol
- Known or suspected impairment of immunological function (including human immunodeficiency virus [HIV] exposure) based on medical history and physical examination
- Previous receipt of polio virus vaccine
- Household contact with a known immunosuppressed individual
- Unwillingness or inability of parents for active follow-up by the study staff
- History of any neurological disorders or seizures
- Any medical condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence or a participant's ability to give informed consent
- Maternal HIV infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BBIBP bOPV Lot 1
Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
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Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 cell culture infectious dose 50% (CCID50)/dose and 10^5.8
CCID50/dose, respectively.
Other Names:
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Experimental: BBIBP bOPV Lot 2
Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
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Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10^6 CCID50/dose and 10^5.8
CCID50/dose, respectively.
Other Names:
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Active Comparator: BioFarma bOPV
Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
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Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 and 10^5.8 infective units per dose, respectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity
Time Frame: 7 days after each vaccination (Weeks 0, 6, 10, and 14)
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Solicited systemic reactogenicity events evaluated during the week after each vaccination included fever, vomiting, diarrhea, decreased appetite/ poor feeding, irritability, and decreased activity. Reactions were recorded by participant's parents via memory aid. Each event was graded as: Mild (Grade 1): No or minimal interference with usual activities; no medical intervention/therapy required, Moderate (Grade 2): Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required, Severe (Grade 3): Marked limitation in ability to perform usual activities; medical intervention/therapy required, or Potentially life-threatening (Grade 4): Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. The overall number of participants who experienced any systemic reaction is reported. Grades are based on maximum severity per participant. |
7 days after each vaccination (Weeks 0, 6, 10, and 14)
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Number of Participants Experiencing Adverse Events
Time Frame: From the time of the first vaccination through 28 days after each vaccination (up to Day 126).
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Adverse events were graded as mild (Grade 1 = No or minimal interference with usual activities; no medical intervention/therapy required), moderate (Grade 2 = Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required), severe (Grade 3 = Marked limitation in ability to perform usual activities; medical intervention/therapy required), or potentially life-threatening (Grade 4 = Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). The overall number of participants who experienced any adverse event is reported. Grades are based on maximum severity per participant. |
From the time of the first vaccination through 28 days after each vaccination (up to Day 126).
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Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1
Time Frame: Screening and 4 weeks post vaccination 4 (Week 18)
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The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days. |
Screening and 4 weeks post vaccination 4 (Week 18)
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Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3
Time Frame: Screening and 4 weeks post vaccination 4 (Week 18)
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The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days. |
Screening and 4 weeks post vaccination 4 (Week 18)
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Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose
Time Frame: 4 weeks post vaccination 4 (Week 18)
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The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Seroconversion was defined as a titer ≥ 1:8 if seronegative at screening, otherwise a ≥ 4-fold increase in adjusted titers (i.e., adjusted for the decay in maternal antibodies, based on a half life of 28 days). |
4 weeks post vaccination 4 (Week 18)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers
Time Frame: 4 weeks post vaccination 4 (Week 18)
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Anti-HBsAg titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination. The enzyme-linked immunosorbent assay (ELISA) assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC). The HBsAb assay was a qualified assay using a kit from BioRad. |
4 weeks post vaccination 4 (Week 18)
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Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection
Time Frame: 28 days after vaccination 4
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Seroprotection was defined as a HBsAg titer ≥ 1:10 The ELISA assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC).
The HBsAb assay was a qualified assay using a kit from BioRad.
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28 days after vaccination 4
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Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers
Time Frame: 4 weeks post vaccination 4 (Week 18)
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Anti-rotavirus immunoglobulin A titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination. The ELISA assay for antibodies to rotavirus was performed at the Children's Hospital Medical Center (CCHMC) using a validated in-house assay. |
4 weeks post vaccination 4 (Week 18)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jessica Cowden, MD, MSPH, US Army Medical Research Unit-Kenya
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Neuromuscular Diseases
- Central Nervous System Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Myelitis
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- VAC-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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