A Phase 2 interventional study of Human Papillomavirus vaccine in Cervical High Grade Squamous Intraepithelial Lesion, sponsored by University of Witwatersrand, South Africa. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-24.
Sponsored by University of Witwatersrand, South Africa · Phase 2, Interventional, and Treatment
Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor response to treatment of cervical cancer precursors. This study will test whether giving the quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced occurrence or cervical cancer precursors in follow-up.
This is a single-center, randomized, double-blinded, placebo-controlled, phase II trial of the quadrivalent human papillomavirus vaccine (qHPV) in HIV-infected women to prevent occurrence of cervical HSIL after LEEP/LLETZ. Participants will undergo colposcopy with directed biopsies, cervical cytology, and stored HPV testing prior to vaccination. Participants will be randomized to the quadrivalent vaccine or saline placebo to be given at entry, week 4, and week 26. Women will have LEEP treatment at week 4. Participants will be seen in follow-up for cervical cytology, colposcopy with directed biopsies at weeks 26 and 52, and stored HPV specimens. Treatment assignment will be unblinded after study follow-up is completed for the last study participant. Women aged 45 or less randomized to placebo will be offered open label HPV vaccine after the study is concluded..
49 studies on the registry are indexed under Squamous Intraepithelial Lesions of the Cervix; 13 are open to participants now.
This study's enrollment of 180 is above the median of 81 across 33 interventional studies indexed under Squamous Intraepithelial Lesions of the Cervix.
Browse Squamous Intraepithelial Lesions of the Cervix studies →University of Witwatersrand, South Africa is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
Biological: Human Papillomavirus vaccine
The participants receive saline placebo at entry, week 4 and week 26.
Biological: Human Papillomavirus vaccine
The participants receive the qHPV vaccine at entry, week 4 and week 26
Also known as: qHPV vaccine
Cervical HSIL
For this trial, the primary endpoint is high-grade squamous intraepithelial lesions (HSIL) or atypical squamous cells suggestive of HSIL found on cervical cytology, or HSIL found on cervical biopsy specimens at either the week 26 or week 52 visit.
Time frame: up to 52 weeks
Cervical Cytology
Cervical cytology abnormalities according to the Bethesda scale. The Bethesda scale classifies cytologic abnormalities. We have dichotomized the outcomes into high grade squamous intraepithelial lesions (HSIL)/atypical squamous cells suggestive of HSIL, or no evidence of intraepithelial lesions or malignancy (NILM)/atypical squamous cells of unknown significance (ASC-US)/low grade squamous intraepithelial lesions (LSIL). We report the number of women in each category.
Time frame: Week 26
| Milestone | Human Papillomavirus Vaccine | Saline Placebo |
|---|---|---|
| Started | 90 | 90 |
| Completed | 87 | 87 |
| Not completed | 3 | 3 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Basaloid cervical cancer | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 3 |
For this trial, the primary endpoint is high-grade squamous intraepithelial lesions (HSIL) or atypical squamous cells suggestive of HSIL found on cervical cytology, or HSIL found on cervical biopsy specimens at either the week 26 or week 52 visit.
| Participants | Human Papillomavirus Vaccine | Saline Placebo |
|---|---|---|
| Cervical HSIL | 46 | 39 |
Cervical cytology abnormalities according to the Bethesda scale. The Bethesda scale classifies cytologic abnormalities. We have dichotomized the outcomes into high grade squamous intraepithelial lesions (HSIL)/atypical squamous cells suggestive of HSIL, or no evidence of intraepithelial lesions or malignancy (NILM)/atypical squamous cells of unknown significance (ASC-US)/low grade squamous intraepithelial lesions (LSIL). We report the number of women in each category.
| Participants | Human Papillomavirus Vaccine | Saline Placebo |
|---|---|---|
| HSIL or ASC-H | 34 | 26 |
| NILM/ASCUS/LSIL | 52 | 59 |
Collected over one year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Papillomavirus Vaccine | 1/90 (1.1%) | 2/90 (2.2%) | 0/90 (0%) |
| Saline Placebo | 0/90 (0%) | 0/90 (0%) | 0/90 (0%) |
| Event | Human Papillomavirus Vaccine | Saline Placebo |
|---|---|---|
| deathCardiac disorders | 1/90 | — |
| cervical cancerReproductive system and breast disorders | 1/90 | — |
| Age, Continuous(years) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| Median | 40.1 (34.8 to 46.6) | 39.1 (35.2 to 44.2) | 39.2 (34.9 to 45.5) |
| Sex: Female, Male(Participants) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| Female | 90 | 90 | 180 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 90 | 90 | 180 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 90 | 86 | 176 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Region of Enrollment(participants) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| South Africa | 90 | 90 | 180 |
| HSIL/ASC-H cervical cytology(Participants) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| Count of participants | 86 | 83 | 169 |
| Plasma HIV-1 RNA <200 copies/mL(Participants) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| Count of participants | 77 | 76 | 153 |
| CD4(cells/mm^3) | Human Papillomavirus Vaccine | Saline Placebo | Total |
|---|---|---|---|
| Median | 511 (300 to 689) | 483 (337 to 745) | 489 (302 to 724) |
1 further baseline measures are reported on the registry.
No study locations are listed for this record.
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Plan to share: Undecided
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Squamous Intraepithelial Lesions of the Cervix→
University of Witwatersrand, South Africa