This study will examine the hypothesis that Gardasil® vaccination might prevent recurrence of genital warts (condylomata acuminata) caused by human papilloma virus (HPV) type 6 or 11.

A randomized, placebo-controlled, phase IIIb HPV vaccination trial with Gardasil® in patients with recurrent condylomata acuminata - GaReCo

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004007-13-DE

Enrollment

200

Registered

2013-06-06

Start date

2013-09-06

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with recurrrent external condylomata acuminata located at the following genital regions: labia minora and majora, introitus vaginae, clitoris, prepuce, glans penis, coronal sulcus and frenulum, perianal skin, perineal region, inguinal- and pubes region. MedDRA version: 20.0 Level: LLT Classification code 10010295 Term: Condylomata acuminatum System Organ Class: 100000016515

Interventions

Trade Name: Gardasil Product Name: Gardasil Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intramuscular use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - External condylomata acuminata (at least one) defined as: condylomata acuminata, condylomata gigantea, keratotic genital warts, papular warty-like lesions within 6 months after removal of previously clinically diagnosed external condylomata acuminata (at least one) - Willingness for single session ablation by scissor snip excision, curettage, electrocautery or laser surgery - Age = 18 - Ability of patient to understand character and individual consequences of the clinical trial - provision of written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: - Contraindications to vaccination with Gardasil® according to the summary of product characteristics - HIV infection or other known immune deficiency disease or current treatment with immunosuppressive drugs - Syphilis (clinical features of first stage and second stage) - Previous treatment with Imiquimod within the last 30 days prior to visit 1 -Previous/concomitant treatment with any other immunomodulators within the last 90 days prior to visit 1 - Previous immunization with Gardasil® or Cervarix - Patients who are unlikely to adhere to the protocol - Participation in other ongoing clinical trials or during their observation period - Pregnancy (women of child bearing potential, WOCBP, will be asked before enrollment and visit 4, and a pregnancy urine test will be perofmed at visits 1-3 before study medication is applied)

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective is to evaluate the efficacy of Gardasil® compared with placebo on the prevention of recurrence of condylomata acuminata. The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination. Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or within 1 cm near the previously treated area and/or (2) appearance of new warts/lesions on other genital sites. All recurrences are verified by biopsy and histology. ;Secondary Objective: To compare Gardasil® versus placebo with respect to: •Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination •Incidence of HPV 6/11 related external condylomata acuminata •Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4 •HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1, visit 3 and visit 4) •Associations between immunological and clinical outcomes •Safety and tolerability ;Primary end point(s): Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or (2) appearance of new warts on other genital sites. All recurrences are verified by biopsy and histology.;Timepoint(s) of evaluation of this end point: The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination.	—

Measure

Time frame

Main Objective: Primary objective is to evaluate the efficacy of Gardasil® compared with placebo on the prevention of recurrence of condylomata acuminata. The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination. Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or within 1 cm near the previously treated area and/or (2) appearance of new warts/lesions on other genital sites. All recurrences are verified by biopsy and histology. ;Secondary Objective: To compare Gardasil® versus placebo with respect to: •Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination •Incidence of HPV 6/11 related external condylomata acuminata •Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4 •HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1, visit 3 and visit 4) •Associations between immunological and clinical outcomes •Safety and tolerability ;Primary end point(s): Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or (2) appearance of new warts on other genital sites. All recurrences are verified by biopsy and histology.;Timepoint(s) of evaluation of this end point: The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination.

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Secondary

Measure	Time frame
Secondary end point(s): To compare Gardasil® versus placebo with respect to: - Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination - Incidence of HPV 6/11 related external condylomata acuminata - Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4 - HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1 and visit 4) - Associations between immunological and clinical outcomes - Safety and tolerability ;Timepoint(s) of evaluation of this end point: Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination	—

Measure

Time frame

Secondary end point(s): To compare Gardasil® versus placebo with respect to: - Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination - Incidence of HPV 6/11 related external condylomata acuminata - Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4 - HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1 and visit 4) - Associations between immunological and clinical outcomes - Safety and tolerability ;Timepoint(s) of evaluation of this end point: Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination

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Countries

Germany

Contacts

Public ContactRepresentative of the Sponsor

Deutsches Krebsforschungszentrum (DKFZ)

m.pawlita@dkfz.de004906221424645

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026