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Human Papillomavirus 6/11 in the Lower Airway of Neonates

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Papillomavirus Infections

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Trial Information

Human Papillomavirus 6/11 in the Lower Airway of Neonates

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

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

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.

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

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).

Outcome Time Frame:

sampling time

Safety Issue:


Principal Investigator

Li-Min Huang, M.D.Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

November 2007

Completion Date:

May 2010

Related Keywords:

  • Papillomavirus Infections
  • Human papillomavirus 6/11
  • Neonates
  • Human papillomavirus 6 or 11 infection
  • Papillomavirus Infections