Genital WartsPhase 3TheraVACCSNCT02750202
Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts
A Phase 3 study testing Quadrivalent HPV vaccine and Hepatitis B vaccine in people with Genital Warts, run by University of Pretoria at 2 sites in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Genital Warts
- What is being tested?
- Quadrivalent HPV vaccine and Hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 1 Jul 2018to 31 Jul 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- HIV negative or HIV infected and CD4 ≥ 300 cells/mm3 OR viral load controlled OR anti retro-viral (ARV) compliant > 6 months
Who cannot join
- 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 malignancy 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
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Tygerberg Hospital
Cape Town, Western Cape
Steve Biko Academic Hospital
Pretoria, Gauteng
About this study
Official title: Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts
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.
- Conditions
- Genital Warts
- Being tested
- Quadrivalent HPV vaccine, Hepatitis B vaccine
- Keywords
- Genital warts, HPV types, HPV vaccine, Cervical cytology, Therapeutic vaccine, Quadrivalent HPV vaccine
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent HPV vaccineBiological
Also called Gardasil, 4 HPV vaccine, q HPV vaccine
Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
Hepatitis B vaccineBiological
Also called Hep B vaccine
Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
| Study group | Role | What they receive |
|---|---|---|
| Quadrivalent HPV vaccine | Active comparator | Three doses of 4 HPV vaccine is given at registered intervals. Receives: Biological: Quadrivalent HPV vaccine |
| Hepatitis B vaccine | Sham comparator | Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine. Receives: Biological: Hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, week 8, 24, 60
Secondary outcomes (5)
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)
Measured: Week 36+
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
Measured: Baseline, week 72
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
Measured: Baseline, week 72
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
Measured: Baseline, week 60
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
Measured: Baseline, week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start1 Jul 2018
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genital WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch
- Responsible party
- Principal investigator, Professor Greta Dreyer, University of Pretoria
- Investigators
- Greta G Dreyer, MMed(O&G)PhD, Principal investigator, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750202
- Sponsor's protocol ID
- Merck-MISP-53183
- Acronym
- TheraVACCS
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2016
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts
- ClinicalTrials.gov ID
- NCT02750202
- Acronym / sponsor ID
- TheraVACCS / Merck-MISP-53183
- Conditions
- Genital Warts
- Keywords
- Genital warts, HPV types, HPV vaccine, Cervical cytology, Therapeutic vaccine, Quadrivalent HPV vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Collaborators
- University of Stellenbosch
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 23 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrivalent HPV vaccine | Active comparator | Biological: Quadrivalent HPV vaccineThree doses of 4 HPV vaccine is given at registered intervals. |
| Hepatitis B vaccine | Sham comparator | Biological: Hepatitis B vaccineThree doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- HIV negative or HIV infected and CD4 ≥ 300 cells/mm3 OR viral load controlled OR anti retro-viral (ARV) compliant > 6 months
Key exclusion criteria (6 listed)
- 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 malignancy including Pneumocystis pneumonia (PCP),Pulmonary tuberculosis (PTB), oesophageal Candida or Kaposi sarcoma or lymphoma
- Known allergy to vaccines or content of vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent HPV vaccineAlso: Gardasil, 4 HPV vaccine, q HPV vaccineQuadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6. | Biological | Quadrivalent HPV vaccine |
| Hepatitis B vaccineAlso: Hep B vaccineHepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6. | Biological | Hepatitis B vaccine |
Primary outcome
Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)
Time frame: Baseline, week 8, 24, 60
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).
5 secondary outcomes
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+
Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72
Time frame: Baseline, week 72
Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72
Time frame: Baseline, week 72
Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60
Time frame: Baseline, week 60
Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60
Time frame: Baseline, week 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Genital Warts
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greta G Dreyer, MMed(O&G)PhD principal investigator
University of Pretoria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent HPV vaccine and Hepatitis B vaccine in people with Genital Warts, run by University of Pretoria at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm) (time frame: Baseline, week 8, 24, 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.