Trial Outcomes & Findings for Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL (NCT NCT01928225)
NCT ID: NCT01928225
Last Updated: 2020-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
up to 52 weeks
Results posted on
2020-06-24
Participant Flow
Participant milestones
| Measure |
Human Papillomavirus Vaccine
Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
Human Papillomavirus vaccine: The participants receive the qHPV vaccine at entry, week 4 and week 26
|
Saline Placebo
The participants receive saline placebo at entry, week 4 and week 26.
Human Papillomavirus vaccine: The participants receive the qHPV vaccine at entry, week 4 and week 26
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
87
|
87
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Human Papillomavirus Vaccine
Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
Human Papillomavirus vaccine: The participants receive the qHPV vaccine at entry, week 4 and week 26
|
Saline Placebo
The participants receive saline placebo at entry, week 4 and week 26.
Human Papillomavirus vaccine: The participants receive the qHPV vaccine at entry, week 4 and week 26
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
basaloid cervical cancer
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Plasma HIV RNA was missing on 17 participants
Baseline characteristics by cohort
| Measure |
Human Papillomavirus Vaccine
n=90 Participants
Participants receive the quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
|
Saline Placebo
n=90 Participants
The participants receive saline placebo at entry, week 4 and week 26.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
n=90 Participants
|
39.1 years
n=90 Participants
|
39.2 years
n=180 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=90 Participants
|
90 Participants
n=90 Participants
|
180 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=90 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=90 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=90 Participants
|
90 Participants
n=90 Participants
|
180 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=90 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=90 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=90 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=90 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Black or African American
|
90 Participants
n=90 Participants
|
86 Participants
n=90 Participants
|
176 Participants
n=180 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=90 Participants
|
1 Participants
n=90 Participants
|
1 Participants
n=180 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=90 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=90 Participants
|
3 Participants
n=90 Participants
|
3 Participants
n=180 Participants
|
|
Region of Enrollment
South Africa
|
90 participants
n=90 Participants
|
90 participants
n=90 Participants
|
180 participants
n=180 Participants
|
|
HSIL/ASC-H cervical cytology
|
86 Participants
n=90 Participants
|
83 Participants
n=90 Participants
|
169 Participants
n=180 Participants
|
|
Plasma HIV-1 RNA <200 copies/mL
|
77 Participants
n=81 Participants • Plasma HIV RNA was missing on 17 participants
|
76 Participants
n=82 Participants • Plasma HIV RNA was missing on 17 participants
|
153 Participants
n=163 Participants • Plasma HIV RNA was missing on 17 participants
|
|
CD4
|
511 cells/mm^3
n=81 Participants • CD4 cell counts were missing on 17 participants
|
483 cells/mm^3
n=82 Participants • CD4 cell counts were missing on 17 participants
|
489 cells/mm^3
n=163 Participants • CD4 cell counts were missing on 17 participants
|
|
Nadir CD4
|
125 cells/mm3
n=89 Participants • Nadir CD4 counts were not available for two participants
|
108 cells/mm3
n=89 Participants • Nadir CD4 counts were not available for two participants
|
116 cells/mm3
n=178 Participants • Nadir CD4 counts were not available for two participants
|
PRIMARY outcome
Timeframe: up to 52 weeksPopulation: Six participants did not have cytologic or histologic samples available for the primary endpoint
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.
Outcome measures
| Measure |
Human Papillomavirus Vaccine
n=87 Participants
Participants receive the quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
|
Saline Placebo
n=87 Participants
The participants receive saline placebo at entry, week 4 and week 26.
|
|---|---|---|
|
Cervical HSIL
|
46 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Comparison of cytologic outcomes between arms at week 26. Nine participants are missing due to a missed visit, loss to follow-up, or unsatisfactory cytology result.
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.
Outcome measures
| Measure |
Human Papillomavirus Vaccine
n=86 Participants
Participants receive the quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
|
Saline Placebo
n=85 Participants
The participants receive saline placebo at entry, week 4 and week 26.
|
|---|---|---|
|
Cervical Cytology
HSIL or ASC-H
|
34 Participants
|
26 Participants
|
|
Cervical Cytology
NILM/ASCUS/LSIL
|
52 Participants
|
59 Participants
|
Adverse Events
Human Papillomavirus Vaccine
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Saline Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Human Papillomavirus Vaccine
n=90 participants at risk
Participants receive the experimental Human Papillomavirus vaccine at entry, week 4 and week 26.
|
Saline Placebo
n=90 participants at risk
The participants receive saline placebo at entry, week 4 and week 26.
|
|---|---|---|
|
Cardiac disorders
death
|
1.1%
1/90 • Number of events 1 • one year
Grade 3 or 4 adverse event related to study vaccination. Please note that only deaths, serious adverse events, and grade 3 or 4 adverse events related to study vaccination were captured. Other grade 3 or 4 events were not captured per protocol. Grade 1 or 2 adverse events were not captured per protocol.
|
0.00%
0/90 • one year
Grade 3 or 4 adverse event related to study vaccination. Please note that only deaths, serious adverse events, and grade 3 or 4 adverse events related to study vaccination were captured. Other grade 3 or 4 events were not captured per protocol. Grade 1 or 2 adverse events were not captured per protocol.
|
|
Reproductive system and breast disorders
cervical cancer
|
1.1%
1/90 • Number of events 90 • one year
Grade 3 or 4 adverse event related to study vaccination. Please note that only deaths, serious adverse events, and grade 3 or 4 adverse events related to study vaccination were captured. Other grade 3 or 4 events were not captured per protocol. Grade 1 or 2 adverse events were not captured per protocol.
|
0.00%
0/90 • one year
Grade 3 or 4 adverse event related to study vaccination. Please note that only deaths, serious adverse events, and grade 3 or 4 adverse events related to study vaccination were captured. Other grade 3 or 4 events were not captured per protocol. Grade 1 or 2 adverse events were not captured per protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place