Prospective Study of Infant Dengue

August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Prospective Study of Dengue Virus Infections During Infancy to Define Correlates of Protective Immunity

Dengue is a common disease and a major health concern in the Philippines. Dengue is caused by a virus transmitted from the bite of an infected mosquito. The purpose of this study is to understand why some infants remain well or have a mild illness, and why other infants become very sick from this virus. Studies have shown that the mother's immune response to dengue can play a role in the infant's immune response and affect whether or not the infant becomes sick. This study will enroll up to 10,000 healthy infants 6-14 weeks old and their mothers in San Pablo City. At the first study visit, information about the mother and birth will be collected and blood samples will be taken from the mother and infant. The infant will have blood drawn at all 3 study visits. The infants will be followed until the age of 16 months. The information obtained from this study may help in the development and future testing of a safe and effective dengue vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a prospective natural history study to define the levels of maternally-acquired neutralizing antibody (Ab) and other correlates of immunity that may protect against the development of dengue hemorrhagic fever in infants. Approximately 10,000 mother-infant pairs will be enrolled to achieve a continuous study cohort of approximately 4,000 children less than 16 months of age. Children leave the study when they reach 16 months of age and are replaced by new participants at 6-14 weeks of age. The investigators will recruit study participants among 3rd trimester pregnant women receiving pre-natal care and women with newborns receiving post-natal care in San Pablo City. The first aim of this study is to define levels of serotype-specific neutralizing Abs associated with protective immunity against symptomatic dengue virus (DV). Neutralizing Ab titers in blood samples collected from Filipino infants before DV infection, and predicted neutralizing Ab titers at the time of illness, will be correlated with disease severity rankings and peak viremia levels. Neutralizing Ab titers at which infants developed symptomatic dengue will be determined. The second aim will be to delineate risk factors contributing to the pathogenesis of dengue hemorrhagic fever (DHF) in infants. From pre-illness blood samples, the association of Ab neutralizing capacity or enhancement of infection with DHF will be measured while controlling for other potential covariates. The covariates will include measures representing viral load and infant host immune responses. The third aim will be to strengthen the capacity for diagnosis and research on dengue in the Philippines. A collaborative and international consortium has been formed to advance dengue research in the Philippines. The research will generate vital data for the effective testing of dengue vaccines and future public health vaccination campaigns throughout the region. This study will enroll up to 10,000 healthy infants 6-14 weeks old and their mothers in San Pablo City. The infants will be followed until the age of 16 months. Mothers and infants will enter the study when the infant is between the ages of 6-14 weeks. At the 1st study visit, data on the mother and the birth will be collected and blood samples will be collected from the mother and infant. The infant will have blood drawn at all 3 study visits. The 2nd study visit will take place when the infant is between the ages of 4-6 months. At this time, data on infant health will be obtained. In all infants, an anticoagulated blood sample will be collected for plasma and PBMC isolation. At age 15-16 months, 250 infants per year will be selected to return for a 3rd study visit. The 250 infants will be randomly selected from those without prior symptomatic dengue and whose study visits 2 and 3 span a significant portion of the peak DV transmission season (June-October). Data on infant health will be obtained and an anticoagulated blood sample for plasma will be collected. Surveillance for DV infections will occur year round and throughout the entire period of an infant's study participation (ages 6 weeks-16 months). Study personnel will screen infants in the study who present with acute febrile illnesses. Those infants will have history and clinical data abstracted, and an acute illness blood sample (serum) taken for dengue diagnostic testing. A convalescent blood sample (serum) will also be taken 10-14 days later. The primary outcome measured will be the identification of DV infection and the classification of disease severity. The secondary outcome measured will be the estimation of peak viremia levels.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel H Libraty
  • Phone Number: (508) 856-4905

Study Locations

  • Philippines
      • Muntinlupa City, Philippines, 1781
        • Recruiting
        • Research Institute For Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Infants born to mother residing in San Pablo Health District
  2. Planned residence in San Pablo Health District for at least 1 year
  3. Age 6-14 weeks*
  4. Informed consent
  5. General good health * Except on study initiation, when over the first 5 months of Year 1 (est. Feb-June 2006), infants between the ages of 6-24 weeks will be allowed to enter the study.

Exclusion Criteria:

  1. Infant born with congenital medical disorder
  2. Mother known to be HIV seropositive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06-0013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings