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CompletedNCT02750202TheraVACCSUpdated Jan 23, 2026Results posted

Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts

A Phase 3 interventional study of Quadrivalent HPV vaccine and Hepatitis B vaccine in Genital Warts, sponsored by University of Pretoria. Completed at 2 sites in South Africa. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by University of Pretoria · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

Study summary

Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in South Africa. Medical and destructive therapy for small warts is generally very effective, however unique problems posed by large or extensive genital warts are not so easily solved and treatment of affected patients remains very challenging. Recurrences are common especially among immune-compromised women. This study will test whether giving the quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment with HPV vaccine can play a role in the control of both malignant and benign HPV disease in women with and without HIV infection through stimulation of the antibody response. In addition, HPV types and other associated diseases will be studied in women receiving HPV vaccine and placebo.

Read the detailed description

Patient selection:

Female patients referred or presenting with genital warts at each site will be eligible and evaluated against the inclusion and exclusion criteria.

Women who are clinically or severely immune-compromised will not be included into the study, but both HIV negative and HIV infected women will be included. Seventy-five women with large or recurrent genital warts will be recruited for this study from 2 sites in South Africa.

Recruitment:

Women with genital warts will be evaluated for inclusion into the study. Those who fit the inclusion criteria and are without any of the exclusion criteria will be fully informed and invited to participate. The first target will be to recruit the first seventy-five consecutive eligible patients who have signed written consent; recruitment for the study will be done for at least 24 months.

First clinical visit:

  • Evaluation genital lesions:

On study entry tumour size and position will be documented graphically and photographically and viral typing from the vulva wart and cervix will be done using Roche Linear Array test.

  • Evaluation immune status:

HIV status and CD 4/CD 8 count will be recorded and tested and the serum will be collected for antibody testing. Cervical disease of clinical significance will be excluded or treatment offered if relevant.

  • Randomization:

Patients will be randomized to receive either quadrivalent HPV or Hepatitis B vaccine.

  • Vaccination:

The participants assigned to the test group will be administered quadrivalent HPV vaccine in three doses as recommended by the manufacturer. Participants assigned to the control group will receive Hepatitis B vaccine in three doses as recommended by the manufacturer.

Follow-up clinical visits: week 8, week 16 and week 24:

  • Evaluation genital lesions:

Three follow up visits will be scheduled two months apart at which time the lesion size will be recorded.

  • Evaluation immune status:

After month 6 or the third visit, the serum will again be collected for antibody level testing.

  • Treatment decision:

According to the clinical response as measured at month six and onwards, locally destructive or surgical treatment will be allowed according to the preference of the clinician and as determined by clinical factors.

Follow up after treatment:

  • Follow up will be done at six monthly intervals.
  • Evaluation genital lesions:

At these visits lesion size will be determined and documented. HPV typing on the cervical and vulval lesions will be repeated at least once.

  • Further treatment of warts:

If needed, repeat surgery and/or local destruction will be allowed and documented. These will be around week 48 and week 72, or study exit

Study exit:

  • Participants will exit the study in week 72.
  • In the absence of harm as determined at interim analysis or suggested by participant disease history, researchers will be unblinded for participant status at study exit and alternative vaccines will be offered to each of these women.
02

Conditions studied

  • Genital Warts

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Keywords

  • Genital warts
  • HPV types
  • HPV vaccine
  • Cervical cytology
  • Therapeutic vaccine
  • Quadrivalent HPV vaccine
03

In context

Condylomata Acuminata

116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.

This study's enrollment of 52 is below the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.

Browse Condylomata Acuminata studies →

Lead sponsor

University of Pretoria is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patient > 16 years
  • Presence of vulvo vaginal genital warts: largest tumour diameter > 3 cm OR Tumour on labia minora and labia majora OR bilateral > 1 cm each side OR Tumour in vagina/cervix as well as on vulva > 1 cm lesion each
  • negative or HIV infected and ≥ 300 cells/mm3 OR viral load controlled OR anti retro-viral (ARV) compliant > 6 months

Exclusion criteria

Exclusion Criteria:

  • Pregnant of planned pregnancy within 6 months
  • Not able to comprehend study method or not able to attend all study visits
  • Previous HPV vaccination
  • Active known opportunistic infection or including Pneumocystis pneumonia (PCP),Pulmonary tuberculosis (PTB), oesophageal Candida or Kaposi sarcoma or lymphoma
  • Known allergy to vaccines or content of vaccine
  • Previous radiation for genital warts
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    Quadrivalent HPV vaccine

    Three doses of 4 HPV vaccine is given at registered intervals.

    Biological: Quadrivalent HPV vaccine

  • Sham comparator
    Hepatitis B vaccine

    Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.

    Biological: Hepatitis B vaccine

Interventions

  • BiologicalQuadrivalent HPV vaccine

    Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

    Also known as: Gardasil, 4 HPV vaccine, q HPV vaccine

  • BiologicalHepatitis B vaccine

    Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

    Also known as: Hep B vaccine

06

What researchers measure

Primary outcomes

  1. Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)

    The number of participants in whom the size of the genital wart lesion(s) measured smaller at Week8, Week24 and Week60 as compared to their baseline measurement (all measured in mm).

    Time frame: Baseline, week 8, 24, 60

Secondary outcomes

  1. Number of Participants Who Acquire Measurable Levels of HPV Type Specific Antibodies During the First 18 Months of the Trail as Measured Using a Competitive Luminex Immuno-assay (cLIA; Reported in Milli-Merck Units [mMU]/ml)

    Time frame: Week 36+

  2. Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72

    The number of participants who change from HPV 6 DNA positive in warts to HPV 6 DNA negative at week 72

    Time frame: Baseline, week 72

  3. Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72

    The number of participants who change from HPV 11 DNA positive in warts to negative at week 72

    Time frame: Baseline, week 72

  4. Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60

    The number of participants who change from HPV 16 DNA positive at baseline to negative at week 60

    Time frame: Baseline, week 60

  5. Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60

    The number of participants who change from HPV 18 DNA positive at baseline to negative at week 60

    Time frame: Baseline, week 60

Other outcomes

  1. Number of Participants Who Change From HIV Negative at Baseline to Positive at Week 48

    The number of participants who change from HIV negative at baseline to positive at week 48

    Time frame: Baseline, week 48

  2. Number of Participants Who Require Surgical Treatment of Warts at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.

    The number of participants who require surgical treatment of warts at any of the clinical assessments during the trial, as judged by the attending clinician.

    Time frame: Week 24, 72

  3. Number of Participants Who Require Surgical Treatment of Cervical Disease at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.

    The number of participants who require surgical treatment of cervical disease at any of the clinical assessments during the trial, as judged by the attending clinician.

    Time frame: Week 24, 72

07

Results

Posted Jan 23, 2026
Limitations and caveats
COVID-19 disruptions impacted hugely on this study: gynaecologic outpatient-, HIV- and other clinics scaled down/closed down, and because these clinics were our main sources in recruiting patients, we experienced a huge challenge to find patients fulfilling our inclusion criteria. Participants also experienced financial stress or lost jobs \& subsequently moved to family homes in rural areas, that led to a number of our participants LTFU. We had to adapt, modify or delay our research project.

Participant flow

Participants were recruited based on referral at two academic medical centers in South Africa between July 2018 and June 2021. First participant was enrolled on 20 July 2018 and the last participant was enrolled in June 2021

Participant flow — Overall Study
MilestoneQuadrivalent HPV VaccineHepatitis B Vaccine
Started2824
Completed2523
Not completed31
Withdrew: Lost to follow-up31

Outcome measures

PrimaryChange in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)

The number of participants in whom the size of the genital wart lesion(s) measured smaller at Week8, Week24 and Week60 as compared to their baseline measurement (all measured in mm).

Time frame:
Baseline, week 8, 24, 60
Reported as:
Count of participants · Participants
Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Week0 vs Week886
Week0 vs Week24117
Week0 vs Week601922
SecondaryNumber of Participants Who Acquire Measurable Levels of HPV Type Specific Antibodies During the First 18 Months of the Trail as Measured Using a Competitive Luminex Immuno-assay (cLIA; Reported in Milli-Merck Units [mMU]/ml)
Time frame:
Week 36+

Results for this outcome have not been posted.

SecondaryNumber of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72

The number of participants who change from HPV 6 DNA positive in warts to HPV 6 DNA negative at week 72

Time frame:
Baseline, week 72
Reported as:
Count of participants · Participants
Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Number of participants HPV6 positive at W0 (wart lesion)109
Number of participants who changed from HPV6 positive at W0 to HPV6 negative at Week72 (wart lesion)12
SecondaryNumber of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72

The number of participants who change from HPV 11 DNA positive in warts to negative at week 72

Time frame:
Baseline, week 72
Reported as:
Count of participants · Participants
Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Number of participants HPV11 positive at W0 (wart lesion)711
Number of participants who changed from HPV11 positive at W0 to HPV11 negative at W72 (wart lesion)12
SecondaryNumber of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60

The number of participants who change from HPV 16 DNA positive at baseline to negative at week 60

Time frame:
Baseline, week 60
Reported as:
Count of participants · Participants
Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Number of participants HPV16 positive at W0 (wart lesion)87
Number of participants who changed from HPV16 positive at W0 to HPV16 negative at W60 (wart lesion)21
SecondaryNumber of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60

The number of participants who change from HPV 18 DNA positive at baseline to negative at week 60

Time frame:
Baseline, week 60
Reported as:
Count of participants · Participants
Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Number of participants HPV18 positive at W0 (wart lesion)32
Number of participants who changed from HPV18 positive at W0 to HPV18 negative at W60 (wart lesion)02
Other pre-specifiedNumber of Participants Who Change From HIV Negative at Baseline to Positive at Week 48

The number of participants who change from HIV negative at baseline to positive at week 48

Time frame:
Baseline, week 48
Reported as:
Count of participants · Participants
Number of Participants Who Change From HIV Negative at Baseline to Positive at Week 48
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Number of participants who were HIV-negative at baseline33
The number of participants who changed from HIV negative at baseline to HIV-positive at week 4800
Other pre-specifiedNumber of Participants Who Require Surgical Treatment of Warts at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.

The number of participants who require surgical treatment of warts at any of the clinical assessments during the trial, as judged by the attending clinician.

Time frame:
Week 24, 72
Reported as:
Count of participants · Participants
Number of Participants Who Require Surgical Treatment of Warts at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Require surgical treatment of warts at W282118
Require surgical treatment of warts at W7221
Other pre-specifiedNumber of Participants Who Require Surgical Treatment of Cervical Disease at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.

The number of participants who require surgical treatment of cervical disease at any of the clinical assessments during the trial, as judged by the attending clinician.

Time frame:
Week 24, 72
Reported as:
Count of participants · Participants
Number of Participants Who Require Surgical Treatment of Cervical Disease at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.
ParticipantsQuadrivalent HPV VaccineHepatitis B Vaccine
Need Large Loop Excision of the Transformation Zone (LLETZ) at Week241010
Need Large Loop Excision of the Transformation Zone (LLETZ) at Week7221

Adverse events

Collected over Adverse event data was collected for 1 year after Week0 (first vaccine dose administrated). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Quadrivalent HPV Vaccine0/28 (0%)0/28 (0%)0/28 (0%)
Hepatitis B Vaccine0/24 (0%)0/24 (0%)0/24 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Mean36.9 ± 9.9632.9 ± 10.2735.0 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Female282452
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Count of participants——0
Self-reported tobacco smoking
Self-reported tobacco smoking(Participants)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Count of participants257
Self-reported medical diseases
Self-reported medical diseases(Participants)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Count of participants71017
HIV-positivity
HIV-positivity(Participants)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Count of participants252146
White cell count
White cell count(cells x 10^9/l)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Mean6.1 ± 1.956.8 ± 2.386.4 ± 2.18
Haemoglobin
Haemoglobin(g/dl)Quadrivalent HPV VaccineHepatitis B VaccineTotal
Mean11.7 ± 1.5812.1 ± 1.3111.9 ± 1.48

20 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Steve Biko Academic Hospital
    Pretoria, Gauteng, South Africa
  • Tygerberg Hospital
    Cape Town, Western Cape, South Africa
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Jul 2025, 84 months.

Results were first posted in Jan 2026, 5 months after primary completion.

Of 28 phase 3 interventional studies under Condylomata Acuminata, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 61. This study's 84 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2016
First posted
Apr 25, 2016
StartActual
Jul 1, 2018
Primary completionActual
Jul 31, 2025
CompletionActual
Jul 31, 2025
Results first posted
Jan 23, 2026
Last update
Jan 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02750202
Lead sponsor
University of Pretoria
Collaborators
University of Stellenbosch
Responsible party
Professor Greta Dreyer (Professor, University of Pretoria) — Principal investigator
First posted
Apr 25, 2016
Start date
Jul 1, 2018
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Results posted
Jan 23, 2026
Last update
Jan 23, 2026

Study contacts

Greta G Dreyer, MMed(O&G)PhD
principal investigator · University of Pretoria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

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