Clinical trial NCT02434770: Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio
First posted: 2015-05-05
Enrollment: 750
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity
timeFrame: 7 days after each vaccination (Weeks 0, 6, 10, and 14)
measure: Number of Participants Experiencing Adverse Events
timeFrame: From the time of the first vaccination through 28 days after each vaccination (up to Day 126).
measure: Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1
timeFrame: Screening and 4 weeks post vaccination 4 (Week 18)
measure: Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3
timeFrame: Screening and 4 weeks post vaccination 4 (Week 18)
measure: Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose
timeFrame: 4 weeks post vaccination 4 (Week 18)
Secondary outcomes:
measure: Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers
timeFrame: 4 weeks post vaccination 4 (Week 18)
measure: Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection
timeFrame: 28 days after vaccination 4
measure: Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers
timeFrame: 4 weeks post vaccination 4 (Week 18)
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute/Walter Reed Project
state: Nyanza
city: Kericho
country: Kenya
facility: Kenya Medical Research Institute (KEMRI)/Walter Reed Project
Study officials:
affiliation: US Army Medical Research Unit-Kenya
name: Jessica Cowden, MD, MSPH
role: STUDY_CHAIR
References: