PoliomyelitisPhase 4NCT01831050
Safety and Immunogenicity of 1 or 2 Doses of IPV in Latin American Infants Primed With Bivalent OPV Vaccine
A Phase 4 study testing Bivalent Oral Polio Vaccine (bOPV), Trivalent Oral Polio Vaccine (tOPV) and Monovalent Oral Polio Vaccine Type 2 (mOPV2) in people with Poliomyelitis, run by Fidec Corporation at 4 sites in 4 countries.
Trial summary
This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children previously vaccinated with 3 doses of bOPV. Read more about this study
- Who is it for?
- Ages 5 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Bivalent Oral Polio Vaccine (bOPV), Trivalent Oral Polio Vaccine (tOPV) and Monovalent Oral Polio Vaccine Type 2 (mOPV2)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,420 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: 6 weeks (-7 to +14 days).
- Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parents or legal guardian as per country regulations
Who cannot join
- Previous vaccination against poliovirus.
- Low birth weight (BW <2,500 gm).
- Multiple pregnancy (twins, triplets, etc.),
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
Show all 12Show fewer
- Known allergy to any component of the study vaccines.
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination.
- Member of the subject's household (living in the same house or apartment unit) who has received OPV vaccine in the last 3 months.
- Subject who, in the opinion of the Investigator or sub-Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Colombia1 site
Centro de Estudios en Infectologia Pediatrica - CEIP
Cali, Cali
Dominican Republic1 site
Hospital Maternidad Nuestra Señora de la Altagracia
Santo Domingo
Guatemala1 site
Clinica Niño Sano Hospital Roosevelt
Guatemala City, Departamento de Guatemala, 01011
About this study
Official title: A Phase 4, Randomized Study to Evaluate the Safety and the Humoral and Intestinal Immunogenicity of One or Two Additional Doses of Licensed Inactivated Polio Vaccines (IPVs) in Latin American Infants Previously Vaccinated With Bivalent Oral Polio Vaccines (bOPVs)
This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children previously vaccinated with 3 doses of bOPV. We will examine the impact of supplemental IPV on stool shedding and humoral immunity, as well as intra-IPV manufacturer comparability, and safety.
Read the detailed description
The world polio eradication effort is near its goal of reducing the number of new cases of polio to zero. However, final and definitive eradication of the disease will require stopping the use of oral polio vaccines (OPV's) which contain live virus and can rarely revert back to disease producing strains. This period will result in a risk of polio re-emergence as immunity will wane while some vaccine poliovirus will still be circulating. Inactivated polio vaccine (IPV) could potentially play a central role during this process but at present barriers of cost and logistics prevent its routine use in resource limited countries, and concerns exist as to whether IPV provides enough immunity in the intestine to reduce the spread of polioviruses in communities once OPV's are stopped. We plan a multi-center trial in Latin America in which we will administer 1 or 2 doses of IPV to children previously vaccinated with an OPV containing type 1 and 3 poliovirus (bOPV), and then assess the shedding in the stool of a type 2 OPV virus administered later. A decrease in the amount of virus shed compared to children not given IPV would indicate that the IPV boosted intestinal immunity, and would suggest that spread of virus in communities could be reduced using this strategy. We will also measure the impact of supplemental IPV's on antibody formation in the blood, which is a marker of protection of the individual from polio disease. A secondary aim will be to compare the immunogenicity and safety of three IPV's produced by different manufacturers. The overall goal will be to inform policy makers in polio eradication regarding the potential role that one or two doses of IPV might play in the final steps toward polio eradication.
- Conditions
- Poliomyelitis
- Being tested
- Bivalent Oral Polio Vaccine (bOPV), Trivalent Oral Polio Vaccine (tOPV), Monovalent Oral Polio Vaccine Type 2 (mOPV2), Sanofi-Pasteur IPV (Sanofi IPV), Glaxo SmithKline IPV (GSK IPV)
- Keywords
- Poliovirus, Inactivated poliovirus vaccine, Trivalent oral polio vaccine, Bivalent oral polio vaccine, Stool shedding index, Polio eradication
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent Oral Polio Vaccine (bOPV)Biological
Also called Bivalent Oral Polio Vaccine, bOPV
Produced by Sanofi Pasteur, Lyon, France, bivalent OPV vaccine contains types 1 and 3 polioviruses and it is indicated for supplementary immunization activities in children from 0 to 5 years of age to prevent or contain outbreaks caused by these 2 serotypes.
Trivalent Oral Polio Vaccine (tOPV)Biological
Also called "OPVERO", Trivalent Oral Polio Vaccine, tOPV
Produced by Sanofi Pasteur, Lyon, France, trivalent OPV vaccine contains types 1, 2, and 3 polioviruses and it is indicated for routine and supplementary prevention of poliomyelitis in children from 0 to 5 years of age.
Monovalent Oral Polio Vaccine Type 2 (mOPV2)Biological
Also called Polio Sabin Mono Two, Monovalent Oral Polio Vaccine Type 2, mOPV2
Licensed monovalent OPV type 2 vaccine (mOPV2) by Glaxo SmithKline, Rixensart, Belgium. Polio Sabin Mono Two (oral) is a monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells.
Sanofi-Pasteur IPV (Sanofi IPV)Biological
Also called Sanofi-Pasteur IPV, IPOL, IMOVAX, Sanofi IPV
Inactivated poliovirus vaccine is produced by Sanofi-Pasteur as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).
Glaxo SmithKline IPV (GSK IPV)Biological
Also called Glaxo SmithKline IPV, POLIORIX, (GSK IPV)
Inactivated poliovirus vaccine is produced by Glaxo SmithKline, Rixensart, Belgium, as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).
Serum Institute of India IPV (SII IPV)Biological
Also called Serum Institute of India IPV, SII IPV
Inactivated poliovirus vaccine produced by Nederland's Vaccin Instituut in Bilthoven, The Netherlands (acquired recently by Serum Institute of India [SII]) is licensed in the producing country and prequalified by the WHO. It consists of a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).
| Study group | Role | What they receive |
|---|---|---|
| G1: Sanofi bOPV Control | Experimental | 210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2) |
| G2: Sanofi bOPV Control | Experimental | 210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2) |
| G3: Trivalent OPV Control | Experimental | 100 infants receiving Trivalent Oral Polio Vaccine (tOPV)' at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks Receives: Biological: Trivalent Oral Polio Vaccine (tOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2) |
| G4: Sanofi bOPV, Sanofi IPV | Experimental | 210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Sanofi-Pasteur IPV (Sanofi IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Biological: Sanofi-Pasteur IPV (Sanofi IPV) |
| G5: Sanofi bOPV, Sanofi 2 IPV | Experimental | 210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 dose of Sanofi-Pasteur IPV (Sanofi IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Biological: Sanofi-Pasteur IPV (Sanofi IPV) |
| G6: Sanofi bOPV, GSK IPV | Experimental | 50 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Glaxo SmithKline IPV (GSK IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Biological: Glaxo SmithKline IPV (GSK IPV) |
| G7: Sanofi bOPV, GSK 2 IPV | Experimental | 190 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 doses of Glaxo SmithKline IPV (GSK IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Biological: Glaxo SmithKline IPV (GSK IPV) |
| G8: Sanofi bOPV, SII IPV | Experimental | 50 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Serum Institute of India IPV (SII IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Biological: Serum Institute of India IPV (SII IPV) |
| G9: Sanofi bOPV, SII 2 IPV | Experimental | 190 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 doses of Serum Institute of India IPV (SII IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks Receives: Biological: Bivalent Oral Polio Vaccine (bOPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Biological: Serum Institute of India IPV (SII IPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the stool poliovirus excretion after mOPV2 challenge (shedding index)
The basis for calculation of the quantitative shedding index endpoint is to measure the change of viral concentrations shed in stool post-mOPV2 challenge from the baseline timepoint at day 0 to 7, 14, 21 and 28 days as measured from time of mOPV challenge. Quantitative shedding index endpoint will be computed as an area under the viral shedding curve based on these three log10-transformed measurements.
Measured: Within 28 days of mOPV2 challenge
Seroconversion and seroprotection to type 1, 2 and 3 poliovirus
The first serologic response endpoint is neutralizing antibody titer defined as the estimated dilution at which 50% neutralizing activity is achieved. The second serologic response endpoint is the binary seroconversion indicator. Seroconversion is considered to be achieved by the time of the subsequent time point if type-specific titers measured at that time are ≥1:8 and > 4-fold over expected levels of maternally-derived antibody computed from the observed titer at baseline assuming an exponential decay with ½ life of 24 days. The third serologic response endpoint of seroprotection is a binary outcome computed from a single antibody titer measurement with seroprotection being achieved if the measured titer is > 1:8.
Measured: At 6 and 14 weeks, and then before and 1 week after mOPV2 challenge
Secondary outcomes (2)
Comparability of seroconversion and seroprotection from different IPV vaccines
To determine whether IPVs from different manufacturers (Sanofi, GSK, SII) are comparable in their ability to induce/boost an antibody response to the 3 poliovirus serotypes in infants vaccinated with 1 or 2 IPV doses after receiving 3 doses of bOPV at 6, 10, and 14 weeks of age
Measured: At 6 and 14 weeks, and then before and 1 week after mOPV2 challenge
Safety of each vaccine (tOPV, bOPV, mOPV, Sanofi IPV, GSK IPV and SII IPV) and each vaccine schedule
- Number of severe adverse events (SAE)throughout the study period
- Number of important medical events (IME) as protocol defined: up to 28 days post-vaccination
- Number of Local \& systemic solicited AEs: 3 days post-vaccination
Measured: 10 months for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidec Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Edwin J Asturias, MD, Principal investigator, University of Colorado, DenverRicardo Ruttimann, MD, Study director, Fidec Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831050
- Sponsor's protocol ID
- 12-1460
- Status last verified
- Aug 2015
- First submitted
- 10 Apr 2013
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lopez-Medina E, Melgar M, Gaensbauer JT, Bandyopadhyay AS, Borate BR, Weldon WC, Ruttimann R, Ward J, Clemens R, Asturias EJ. Inactivated polio vaccines from three different manufacturers have equivalent safety and immunogenicity when given as 1 or 2 additional doses after bivalent OPV: Results from a randomized controlled trial in Latin America. Vaccine. 2017 Jun 16;35(28):3591-3597. doi: 10.1016/j.vaccine.2017.04.041. Epub 2017 Apr 25.
PubMed 28455172Asturias EJ, Bandyopadhyay AS, Self S, Rivera L, Saez-Llorens X, Lopez E, Melgar M, Gaensbauer JT, Weldon WC, Oberste MS, Borate BR, Gast C, Clemens R, Orenstein W, O'Ryan G M, Jimeno J, Clemens SA, Ward J, Ruttimann R; Latin American IPV001BMG Study Group. Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants: an open-label randomised controlled trial. Lancet. 2016 Jul 9;388(10040):158-69. doi: 10.1016/S0140-6736(16)00703-0. Epub 2016 May 19.
PubMed 27212429
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized Study to Evaluate the Safety and the Humoral and Intestinal Immunogenicity of One or Two Additional Doses of Licensed Inactivated Polio Vaccines (IPVs) in Latin American Infants Previously Vaccinated With Bivalent Oral Polio Vaccines (bOPVs)
- ClinicalTrials.gov ID
- NCT01831050
- Acronym / sponsor ID
- 12-1460
- Conditions
- Poliomyelitis
- Keywords
- Poliovirus, Inactivated poliovirus vaccine, Trivalent oral polio vaccine, Bivalent oral polio vaccine, Stool shedding index, Polio eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,420 participants (estimated)
- Lead sponsor
- Fidec CorporationUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children previously vaccinated with 3 doses of bOPV. We will examine the impact of supplemental IPV on stool shedding and humoral immunity, as well as intra-IPV manufacturer comparability, and safety.
Detailed description
The world polio eradication effort is near its goal of reducing the number of new cases of polio to zero. However, final and definitive eradication of the disease will require stopping the use of oral polio vaccines (OPV's) which contain live virus and can rarely revert back to disease producing strains. This period will result in a risk of polio re-emergence as immunity will wane while some vaccine poliovirus will still be circulating. Inactivated polio vaccine (IPV) could potentially play a central role during this process but at present barriers of cost and logistics prevent its routine use in resource limited countries, and concerns exist as to whether IPV provides enough immunity in the intestine to reduce the spread of polioviruses in communities once OPV's are stopped. We plan a multi-center trial in Latin America in which we will administer 1 or 2 doses of IPV to children previously vaccinated with an OPV containing type 1 and 3 poliovirus (bOPV), and then assess the shedding in the stool of a type 2 OPV virus administered later. A decrease in the amount of virus shed compared to children not given IPV would indicate that the IPV boosted intestinal immunity, and would suggest that spread of virus in communities could be reduced using this strategy. We will also measure the impact of supplemental IPV's on antibody formation in the blood, which is a marker of protection of the individual from polio disease. A secondary aim will be to compare the immunogenicity and safety of three IPV's produced by different manufacturers. The overall goal will be to inform policy makers in polio eradication regarding the potential role that one or two doses of IPV might play in the final steps toward polio eradication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| G1: Sanofi bOPV Control | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks |
| G2: Sanofi bOPV Control | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks |
| G3: Trivalent OPV Control | Experimental | Biological: Trivalent Oral Polio Vaccine (tOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)100 infants receiving Trivalent Oral Polio Vaccine (tOPV)' at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks |
| G4: Sanofi bOPV, Sanofi IPV | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Sanofi-Pasteur IPV (Sanofi IPV)210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Sanofi-Pasteur IPV (Sanofi IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks |
| G5: Sanofi bOPV, Sanofi 2 IPV | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Sanofi-Pasteur IPV (Sanofi IPV)210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 dose of Sanofi-Pasteur IPV (Sanofi IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks |
| G6: Sanofi bOPV, GSK IPV | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Glaxo SmithKline IPV (GSK IPV)50 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Glaxo SmithKline IPV (GSK IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks |
| G7: Sanofi bOPV, GSK 2 IPV | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Glaxo SmithKline IPV (GSK IPV)190 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 doses of Glaxo SmithKline IPV (GSK IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks |
| G8: Sanofi bOPV, SII IPV | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Serum Institute of India IPV (SII IPV)50 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Serum Institute of India IPV (SII IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks |
| G9: Sanofi bOPV, SII 2 IPV | Experimental | Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Serum Institute of India IPV (SII IPV)190 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 doses of Serum Institute of India IPV (SII IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks |
Who may qualify
- Ages
- 5 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 6 weeks (-7 to +14 days).
- Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parents or legal guardian as per country regulations
Key exclusion criteria (12 listed)
- Previous vaccination against poliovirus.
- Low birth weight (BW <2,500 gm).
- Multiple pregnancy (twins, triplets, etc.),
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bivalent Oral Polio Vaccine (bOPV)Also: Bivalent Oral Polio Vaccine, bOPVProduced by Sanofi Pasteur, Lyon, France, bivalent OPV vaccine contains types 1 and 3 polioviruses and it is indicated for supplementary immunization activities in children from 0 to 5 years of age to prevent or contain outbreaks caused by these 2 serotypes. | Biological | G1: Sanofi bOPV Control, G2: Sanofi bOPV Control, G4: Sanofi bOPV, Sanofi IPV, G5: Sanofi bOPV, Sanofi 2 IPV, G6: Sanofi bOPV, GSK IPV, G7: Sanofi bOPV, GSK 2 IPV, G8: Sanofi bOPV, SII IPV, G9: Sanofi bOPV, SII 2 IPV |
| Trivalent Oral Polio Vaccine (tOPV)Also: "OPVERO", Trivalent Oral Polio Vaccine, tOPVProduced by Sanofi Pasteur, Lyon, France, trivalent OPV vaccine contains types 1, 2, and 3 polioviruses and it is indicated for routine and supplementary prevention of poliomyelitis in children from 0 to 5 years of age. | Biological | G3: Trivalent OPV Control |
| Monovalent Oral Polio Vaccine Type 2 (mOPV2)Also: Polio Sabin Mono Two, Monovalent Oral Polio Vaccine Type 2, mOPV2Licensed monovalent OPV type 2 vaccine (mOPV2) by Glaxo SmithKline, Rixensart, Belgium. Polio Sabin Mono Two (oral) is a monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. | Biological | G1: Sanofi bOPV Control, G2: Sanofi bOPV Control, G3: Trivalent OPV Control, G4: Sanofi bOPV, Sanofi IPV, G5: Sanofi bOPV, Sanofi 2 IPV, G6: Sanofi bOPV, GSK IPV, G7: Sanofi bOPV, GSK 2 IPV, G8: Sanofi bOPV, SII IPV, G9: Sanofi bOPV, SII 2 IPV |
| Sanofi-Pasteur IPV (Sanofi IPV)Also: Sanofi-Pasteur IPV, IPOL, IMOVAX, Sanofi IPVInactivated poliovirus vaccine is produced by Sanofi-Pasteur as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3). | Biological | G4: Sanofi bOPV, Sanofi IPV, G5: Sanofi bOPV, Sanofi 2 IPV |
| Glaxo SmithKline IPV (GSK IPV)Also: Glaxo SmithKline IPV, POLIORIX, (GSK IPV)Inactivated poliovirus vaccine is produced by Glaxo SmithKline, Rixensart, Belgium, as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3). | Biological | G6: Sanofi bOPV, GSK IPV, G7: Sanofi bOPV, GSK 2 IPV |
| Serum Institute of India IPV (SII IPV)Also: Serum Institute of India IPV, SII IPVInactivated poliovirus vaccine produced by Nederland's Vaccin Instituut in Bilthoven, The Netherlands (acquired recently by Serum Institute of India [SII]) is licensed in the producing country and prequalified by the WHO. It consists of a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3). | Biological | G8: Sanofi bOPV, SII IPV, G9: Sanofi bOPV, SII 2 IPV |
Primary outcome
Change in the stool poliovirus excretion after mOPV2 challenge (shedding index)
Time frame: Within 28 days of mOPV2 challenge
The basis for calculation of the quantitative shedding index endpoint is to measure the change of viral concentrations shed in stool post-mOPV2 challenge from the baseline timepoint at day 0 to 7, 14, 21 and 28 days as measured from time of mOPV challenge. Quantitative shedding index endpoint will be computed as an area under the viral shedding curve based on these three log10-transformed measurements.
Seroconversion and seroprotection to type 1, 2 and 3 poliovirus
Time frame: At 6 and 14 weeks, and then before and 1 week after mOPV2 challenge
The first serologic response endpoint is neutralizing antibody titer defined as the estimated dilution at which 50% neutralizing activity is achieved. The second serologic response endpoint is the binary seroconversion indicator. Seroconversion is considered to be achieved by the time of the subsequent time point if type-specific titers measured at that time are ≥1:8 and > 4-fold over expected levels of maternally-derived antibody computed from the observed titer at baseline assuming an exponential decay with ½ life of 24 days. The third serologic response endpoint of seroprotection is a binary outcome computed from a single antibody titer measurement with seroprotection being achieved if the measured titer is > 1:8.
2 secondary outcomes
Comparability of seroconversion and seroprotection from different IPV vaccines
Time frame: At 6 and 14 weeks, and then before and 1 week after mOPV2 challenge
Safety of each vaccine (tOPV, bOPV, mOPV, Sanofi IPV, GSK IPV and SII IPV) and each vaccine schedule
Time frame: 10 months for each subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Derived from this study: PubMed 28455172Lopez-Medina E, Melgar M, Gaensbauer JT, Bandyopadhyay AS, Borate BR, Weldon WC, Ruttimann R, Ward J, Clemens R, Asturias EJ. Inactivated polio vaccines from three different manufacturers have equivalent safety and immunogenicity when given as 1 or 2 additional doses after bivalent OPV: Results from a randomized controlled trial in Latin America. Vaccine. 2017 Jun 16;35(28):3591-3597. doi: 10.1016/j.vaccine.2017.04.041. Epub 2017 Apr 25.
- Derived from this study: PubMed 27212429Asturias EJ, Bandyopadhyay AS, Self S, Rivera L, Saez-Llorens X, Lopez E, Melgar M, Gaensbauer JT, Weldon WC, Oberste MS, Borate BR, Gast C, Clemens R, Orenstein W, O'Ryan G M, Jimeno J, Clemens SA, Ward J, Ruttimann R; Latin American IPV001BMG Study Group. Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants: an open-label randomised controlled trial. Lancet. 2016 Jul 9;388(10040):158-69. doi: 10.1016/S0140-6736(16)00703-0. Epub 2016 May 19.
Related trials for Poliomyelitis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin J Asturias, MD principal investigator
University of Colorado, Denver
Ricardo Ruttimann, MD study director
Fidec Corporation
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalent Oral Polio Vaccine (bOPV), Trivalent Oral Polio Vaccine (tOPV) and Monovalent Oral Polio Vaccine Type 2 (mOPV2) in people with Poliomyelitis, run by Fidec Corporation at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, Dominican Republic, Guatemala, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the stool poliovirus excretion after mOPV2 challenge (shedding index) (time frame: Within 28 days of mOPV2 challenge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01831050, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.