4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

National Institute of Child Health, Hungary

Status and phase: Unknown; Phase 3

Conditions: Recurrent Respiratory Papillomatosis

Treatments: Biological: 4-valent HPV vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01995721

50934

Details and patient eligibility

About

Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.

After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

Full description

1. Enrollment

   • ear-nose-throat (ENT) examination + oesophagoscopy

   • immunological assessment

     • assessment of selected humoral (antibodies) and
     • cellular immune response parameters(INF gamma and granzyme B testing)
     • in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine

2. Immunization with 4-valent HPV vaccine at 0,2,6 months

3. Follow up

   • 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase)
   • 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• respiratory papillomatosis
• at least 3 relapses in patient history
• HPV 6 and/or 11 positive papillomas
• able to mount neutralizing antibodies

Exclusion criteria

• other chronic underlying condition
• other HPV type
• no antibody response

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

4-valent HPV vaccine

Experimental group

Description:

4-valent HPV vaccine administered in months 0., 2., 6.

Treatment:

Biological: 4-valent HPV vaccine