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Completed

NCT Number: NCT01559636

Diarrhea and Bivalent Oral Polio Vaccine Immunity

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.

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Key information

Conditions

Seroimmunity Blood-Borne Infections Central Nervous System Diseases Central Nervous System Infections Communicable Diseases Diarrhea Enterovirus Infections Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Picornaviridae Infections Polio Poliomyelitis RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Signs and Symptoms, Digestive Spinal Cord Diseases Urogenital Diseases Virus Diseases

Age range

6 week–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medicine

Kathmandu, Nepal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bivalent oral polio vaccine

Biological

vaccine given during immunization campaigns

Primary outcomes

  1. 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.

Secondary outcomes

  1. Frequencies of enteric infections isolated in stool among infants with diarrhea vs. infants without diarrhea

    Time frame: Date of enrollment

    One stool sample will be collected from each infant the day of enrollment.

  2. Proportion of infants seropositive after receipt of 3 doses of any oral polio vaccine

    Time frame: 4 weeks after date of bOPV dose

    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.

  3. Proportion of infants with factors associated with poor bOPV seroconversion/boosting

    Time frame: 4 weeks after date of bOPV dose

    Multivariable modeling will be used to assess factors associated with poor bOPV seroconversion/boosting.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Tribhuvan University, Nepal

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2012
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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