Diarrhea and Bivalent Oral Polio Vaccine Immunity

Diarrhea Clinical Trial

Official title:

Effect of Diarrheal Disease on Bivalent Oral Polio Vaccine (bOPV) Immune Response in Infants in Nepal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559636
• Other study ID #: CDC-458-GID-037
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: October 13, 2015
• Start date: August 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2015
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 11 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diarrhea
• Polio
• Poliomyelitis
• Seroimmunity

Intervention

Biological:
• bivalent oral polio vaccine
vaccine given during immunization campaigns

Locations

Country	Name	City	State
Nepal	Institute of Medicine	Kathmandu

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks after date of bOPV dose	No
Secondary	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.	Date of enrollment	No
Secondary	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.	4 weeks after date of bOPV dose	No
Secondary	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.	4 weeks after date of bOPV dose	No

External Links

•   Global Polio Eradication Initiative