Human Papillomavirus 6/11 in the Lower Airway of Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549250
Recruitment Status : Completed
First Posted : October 25, 2007
Last Update Posted : July 5, 2010
Merck Sharp & Dohme Corp.
Information provided by:
National Taiwan University Hospital

Brief Summary:
Vertical transmission of human papillomavirus (HPV) 6/11 leads to infection in the lower airway of neonates. The presence of HPV 6/11 may later cause juvenile onset recurrent respiratory papillomatosis (JORRP).

Condition or disease
Papillomavirus Infections

Detailed Description:

Juvenile onset recurrent respiratory papillomatosis (JORRP) is caused by human papillomavirus (HPV), almost exclusively type 6 and 11. The disease is well-known for its recurrence and difficulty in management. The peak incidence is around 2-3 year of age. Since HPV infection has always been considered a sexual transmitted disease, the rate of vertical or perinatal transmission had been studied extensively. However, few studies focused on HPV 6 and 11.

To the best of our knowledge, in the several large-scale studies available for HPV infection in the newborn, no case of HPV 6/11 infection had been identified. Most of these studies had specimens taken from the oral cavity of newborn. In contrast to the occurrence of JORRP in the larynx, trachea and lower respiratory tract, if vertical transmission of HPV 6/11 does exist, specimens from lower respiratory tract of newborn is mandatory to detect any possible infection.

There is no study available about HPV 6/11 infection in the lower airway of healthy neonate/children. In some studies of adults, the prevalence of HPV 6/11 in larynx or vocal cord of patients without recurrent respiratory papillomatosis ranged between 19~25%. In contrast, several studies had specimen taken from the non-disease lower airway (trachea, vocal cord) and/or larynx of patients with JORRP. Except for the almost 100% presence of HPV 6/11 DNA in the diseased site, 38~60% of specimens taken from non-disease site were also positive for the viral DNA, showing that latent infection is not infrequent in normal airway, and may later cause active disease by mechanism still unknown to date.

The largest national registry of JORRP to date was conducted in the US and had 603 cases. The study showed that there was a significant association between younger age at diagnosis and papillomas occurring below the larynx (mean age 4.6 VS 2.1 years, p=0.009). This finding further emphasizes the importance of getting specimen at the laryngeal level, especially in neonates.

The aim of our study is to examine the presence of HPV 6/11 DNA in lower respiratory tract specimens from newborn. To get the lower respiratory tract specimen without unnecessary medical intervention, only those needed intubation will be included in this study. Specimens from bronchial lavage (or scraping?) will be obtained after getting informed consent from the parents, and undergo PCR to identify the presence of HPV 6/11 DNA.

Study Type : Observational
Actual Enrollment : 114 participants
Time Perspective: Prospective
Official Title: Human Papillomavirus 6/11 in the Lower Airway of Neonates
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The purpose of this study is to identify prospectively the presence and the estimated prevalence of HPV 6/11 DNA in the lower airway of neonates by polymerase chain reaction (PCR). [ Time Frame: sampling time ]

Biospecimen Retention:   Samples With DNA
Bronchial lavage fluid

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All intubated neonates younger than 1 month-old admitted to our neonatal intensive care unit.

Inclusion Criteria:

  • In order to get respiratory specimens at or below the larynx, intubated neonates younger than one-month-old admitted to our neonatal intensive care unit will be included in this study after getting informed consent from their families.

Exclusion Criteria:

  • Unless the neonate's condition is too critical to have the following procedure performed, gestational age, co-morbidity and maternal status of HPV infection are not exclusion criteria for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00549250

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Li-Min Huang, M.D.Ph.D. National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT00549250     History of Changes
Other Study ID Numbers: 200710007R
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: June 2010

Keywords provided by National Taiwan University Hospital:
Human papillomavirus 6/11
Human papillomavirus 6 or 11 infection

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections