SeroimmunityNCT01559636
Diarrhea and Bivalent Oral Polio Vaccine Immunity
A study testing bivalent oral polio vaccine in people with Seroimmunity and Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Nepal.
Trial summary
Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate eradication. One concern in this effort is that some populations have decreased immunogenicity to oral poliovirus vaccine (OPV). Read more about this study
- Who is it for?
- Ages 6 weeks to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Seroimmunity, Diarrhea, Polio
- What is being tested?
- bivalent oral polio vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 699 participants
- Where
- 1 siteNepal
- Study dates
- Aug 2012to Oct 2013
- Phase
- Interventional
- 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 6 weeks to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The investigators will be including Nepali infants aged at least 6 weeks and no more than 12 months, who have received <3 doses of OPV (cumulative from routine and SIA) and present to outpatient clinics in participating study sites. Whenever possible, the child's immunization status based on the caretaker's report will be cross-checked with available immunization cards.
- Infants with diarrhea must also have:
- Current diarrhea, defined as three loose stools per day in the past 24 hours. This may include children with acute or chronic diarrhea, low grade fever, and those with intermittent vomiting who are able to tolerate oral fluids and do not present with severe dehydration on the initial visit.
- Non-diarrhea children also must:
- Present with other, non-diarrheal minor acute complaints. This can include but is not limited to children presenting for non-severe illnesses such as skin problems (e.g., rash), conjunctivitis, and mild cough, congestion, or cold. These children should be diarrhea-free for at least two weeks prior to enrolment.
Who cannot join
- Infants younger than 6 weeks or older than 12 months of age
- Infants who have received 3 or more cumulative doses of OPV (including both routine and SIAs)
- Infants who require hospitalization or are deemed too ill to participate by the study site clinician
- Infants with blood in the stool (as this may represent more severe cases including dysentery, or non-infectious severe illnesses such as intussusception)
- Infants who require IV medications for a severe illness (e.g., pneumonia); however, this does not include medications for mild or moderate illnesses, such as paracetamol, ORS, eye ointment, etc.
- Infants who have a chronic underlying illness requiring long term medications
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- Infants who are unable to take any oral fluids by mouth, require IV hydration and therefore would be unable to tolerate oral medications in the study
- Infants whose caregivers do not consent, or are not present to give consent, to the study
- Infants who will not be able to return to the clinic to participate the full length of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Diarrheal Disease on Bivalent Oral Polio Vaccine (bOPV) Immune Response in Infants in Nepal
Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate eradication. One concern in this effort is that some populations have decreased immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV) was recommended for use in immunization campaigns, and will likely replace tOPV in routine immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been studied.
This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who reside in Nepal. The investigators conducted a prospective, interventional study that assessed immune response to bOPV among infants with and without diarrhea. Immune responses were compared among infants with and without diarrhea.
This study will result in a better understanding of the factors that decrease the ability of some children to seroconvert to OPV and be protected from poliomyelitis infection.
- Conditions
- Seroimmunity, Diarrhea, Polio
- Being tested
- bivalent oral polio vaccine
- Keywords
- seroconversion, oral polio vaccine, OPV, poliomyelitis, diarrhea, seroimmunity
- Medical subject headings
- Diarrhea, Poliomyelitis, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalent oral polio vaccineBiological
vaccine given during immunization campaigns
| Study group | Role | What they receive |
|---|---|---|
| Diarrhea | Active comparator | Infants with diarrhea will have blood and stool sample taken and receive zinc and ORS. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion. Receives: Biological: bivalent oral polio vaccine |
| Non-diarrhea | Active comparator | Infants without diarrhea will have blood and stool sample taken and receive multivitamins. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion. Receives: Biological: bivalent oral polio vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of infants who seroconvert or boost in antibody titers in the diarrhea arm compared to the non-diarrhea arm
Seropositive: antibody titer of at least 1:8 for poliovirus type 1 or 3
Seronegative: antibody titer of less than 1:8 for poliovirus type 1 or 3
Seroconversion: proportion of children who change from seronegative to seropositive to types 1 or 3, four weeks after receipt of bOPV.
Boost (increase in titer): seropositives at baseline who increase at least 4-fold in antibody titer four weeks after receipt of bOPV.
Measured: 4 weeks after date of bOPV dose
Secondary outcomes (3)
Frequencies of enteric infections isolated in stool among infants with diarrhea vs. infants without diarrhea
One stool sample will be collected from each infant the day of enrollment.
Measured: Date of enrollment
Proportion of infants seropositive after receipt of 3 doses of any oral polio vaccine
A subset of infants who received two doses of any OPV prior to study entry, and a third dose of bOPV as part of the study, will have their seroimmunity reported. This outcome is intended as a proxy measure for seroprevalence after 3 doses of OPV, which is how the vaccine is used in routine immunization.
Measured: 4 weeks after date of bOPV dose
Proportion of infants with factors associated with poor bOPV seroconversion/boosting
Multivariable modeling will be used to assess factors associated with poor bOPV seroconversion/boosting.
Measured: 4 weeks after date of bOPV dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeroimmunityStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Tribhuvan University, Nepal
- Responsible party
- Sponsor
- Investigators
- Cristina V Cardemil, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559636
- Sponsor's protocol ID
- CDC-458-GID-037
- Status last verified
- Oct 2015
- First submitted
- 4 Jan 2012
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cardemil CV, Estivariz C, Shrestha L, Sherchand JB, Sharma A, Gary HE Jr, Oberste MS, Weldon WC 3rd, Bowen MD, Vinje J, Schluter WW, Anand A, Mach O, Chu SY. The effect of diarrheal disease on bivalent oral polio vaccine (bOPV) immune response in infants in Nepal. Vaccine. 2016 May 11;34(22):2519-26. doi: 10.1016/j.vaccine.2016.03.027. Epub 2016 Apr 13.
PubMed 27085172
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diarrheal Disease on Bivalent Oral Polio Vaccine (bOPV) Immune Response in Infants in Nepal
- ClinicalTrials.gov ID
- NCT01559636
- Acronym / sponsor ID
- CDC-458-GID-037
- Conditions
- Seroimmunity, Diarrhea, Polio
- Keywords
- seroconversion, oral polio vaccine, OPV, poliomyelitis, diarrhea, seroimmunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Tribhuvan University, Nepal
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Mar 2012 (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.
Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate eradication. One concern in this effort is that some populations have decreased immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV) was recommended for use in immunization campaigns, and will likely replace tOPV in routine immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been studied.
This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who reside in Nepal. The investigators conducted a prospective, interventional study that assessed immune response to bOPV among infants with and without diarrhea. Immune responses were compared among infants with and without diarrhea.
This study will result in a better understanding of the factors that decrease the ability of some children to seroconvert to OPV and be protected from poliomyelitis infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diarrhea | Active comparator | Biological: bivalent oral polio vaccineInfants with diarrhea will have blood and stool sample taken and receive zinc and ORS. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion. |
| Non-diarrhea | Active comparator | Biological: bivalent oral polio vaccineInfants without diarrhea will have blood and stool sample taken and receive multivitamins. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion. |
Who may qualify
- Ages
- 6 weeks to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The investigators will be including Nepali infants aged at least 6 weeks and no more than 12 months, who have received <3 doses of OPV (cumulative from routine and SIA) and present to outpatient clinics in participating study sites. Whenever possible, the child's immunization status based on the caretaker's report will be cross-checked with available immunization cards.
- Infants with diarrhea must also have:
- Current diarrhea, defined as three loose stools per day in the past 24 hours. This may include children with acute or chronic diarrhea, low grade fever, and those with intermittent vomiting who are able to tolerate oral fluids and do not present with severe dehydration on the initial visit.
- Non-diarrhea children also must:
- Present with other, non-diarrheal minor acute complaints. This can include but is not limited to children presenting for non-severe illnesses such as skin problems (e.g., rash), conjunctivitis, and mild cough, congestion, or cold. These children should be diarrhea-free for at least two weeks prior to enrolment.
Key exclusion criteria (9 listed)
- Infants younger than 6 weeks or older than 12 months of age
- Infants who have received 3 or more cumulative doses of OPV (including both routine and SIAs)
- Infants who require hospitalization or are deemed too ill to participate by the study site clinician
- Infants with blood in the stool (as this may represent more severe cases including dysentery, or non-infectious severe illnesses such as intussusception)
- Infants who require IV medications for a severe illness (e.g., pneumonia); however, this does not include medications for mild or moderate illnesses, such as paracetamol, ORS, eye ointment, etc.
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 vaccinevaccine given during immunization campaigns | Biological | Diarrhea, Non-diarrhea |
Primary outcome
The proportion of infants who seroconvert or boost in antibody titers in the diarrhea arm compared to the non-diarrhea arm
Time frame: 4 weeks after date of bOPV dose
Seropositive: antibody titer of at least 1:8 for poliovirus type 1 or 3 Seronegative: antibody titer of less than 1:8 for poliovirus type 1 or 3 Seroconversion: proportion of children who change from seronegative to seropositive to types 1 or 3, four weeks after receipt of bOPV. Boost (increase in titer): seropositives at baseline who increase at least 4-fold in antibody titer four weeks after receipt of bOPV.
3 secondary outcomes
Frequencies of enteric infections isolated in stool among infants with diarrhea vs. infants without diarrhea
Time frame: Date of enrollment
Proportion of infants seropositive after receipt of 3 doses of any oral polio vaccine
Time frame: 4 weeks after date of bOPV dose
Proportion of infants with factors associated with poor bOPV seroconversion/boosting
Time frame: 4 weeks after date of bOPV dose
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 15 Oct 2015.
- Derived from this study: PubMed 27085172Cardemil CV, Estivariz C, Shrestha L, Sherchand JB, Sharma A, Gary HE Jr, Oberste MS, Weldon WC 3rd, Bowen MD, Vinje J, Schluter WW, Anand A, Mach O, Chu SY. The effect of diarrheal disease on bivalent oral polio vaccine (bOPV) immune response in infants in Nepal. Vaccine. 2016 May 11;34(22):2519-26. doi: 10.1016/j.vaccine.2016.03.027. Epub 2016 Apr 13.
- Global Polio Eradication InitiativeLink provided by the sponsor.
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.
Cristina V Cardemil, MD, MPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bivalent oral polio vaccine in people with Seroimmunity and Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Nepal.
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 5 inclusion and 9 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. 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.
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?
The proportion of infants who seroconvert or boost in antibody titers in the diarrhea arm compared to the non-diarrhea arm (time frame: 4 weeks after date of bOPV dose). 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 NCT01559636, which also lists 1 linked publication.
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 15 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.