NCT01209325 · OUTCOME
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males · Source last updated 2020-08-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mMU/mL
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- at 7 and 24 Months
What was measured
Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months
Analysis population: Eligible participants who received at least one vaccination and who were sero-negative for HPV 16 at baseline with evaluable serum assessments.
Groups in this outcome
Month 7 Visit
Month 7 visit after enrollment
Month 24 Visit
Month 24 visit after enrollment
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 76 |
|---|
| Month 24 Visit | 66 |
|---|
Reported measurements
Age<24 years
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 49 |
|---|
| Month 24 Visit | 44 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 1572 | Not reported | 1239 | 1995 | Not reported |
|---|
| Month 24 Visit | 268 | Not reported | 185 | 388 | Not reported |
|---|
Age>=24 years
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 27 |
|---|
| Month 24 Visit | 22 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 1467 | Not reported | 1013 | 2126 | Not reported |
|---|
| Month 24 Visit | 272 | Not reported | 131 | 566 | Not reported |
|---|
Baseline HIV viral load <=75
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 68 |
|---|
| Month 24 Visit | 57 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 1630 | Not reported | 1328 | 2002 | Not reported |
|---|
| Month 24 Visit | 282 | Not reported | 200 | 398 | Not reported |
|---|
Baseline HIV viral load >75
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 8 |
|---|
| Month 24 Visit | 9 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 914 | Not reported | 441 | 1894 | Not reported |
|---|
| Month 24 Visit | 201 | Not reported | 51 | 795 | Not reported |
|---|
Baseline CD4 <=500
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 27 |
|---|
| Month 24 Visit | 24 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 1556 | Not reported | 1123 | 2156 | Not reported |
|---|
| Month 24 Visit | 359 | Not reported | 218 | 590 | Not reported |
|---|
Baseline CD4 >500
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 49 |
|---|
| Month 24 Visit | 42 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 1522 | Not reported | 1178 | 1967 | Not reported |
|---|
| Month 24 Visit | 229 | Not reported | 145 | 359 | Not reported |
|---|
Nadir CD4 <=350
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 40 |
|---|
| Month 24 Visit | 37 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 1390 | Not reported | 1040 | 1857 | Not reported |
|---|
| Month 24 Visit | 245 | Not reported | 151 | 395 | Not reported |
|---|
Nadir CD4>350
Analysis denominator · Participants
| Group | Source count |
|---|
| Month 7 Visit | 32 |
|---|
| Month 24 Visit | 27 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Month 7 Visit | 1752 | Not reported | 1303 | 2354 | Not reported |
|---|
| Month 24 Visit | 313 | Not reported | 186 | 528 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1239
- upper Limit
- 1995
- value
- 1572
- group Id
- OG001
- lower Limit
- 185
- upper Limit
- 388
- value
- 268
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 44
- units
- Participants
- title
- Age<24 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1013
- upper Limit
- 2126
- value
- 1467
- group Id
- OG001
- lower Limit
- 131
- upper Limit
- 566
- value
- 272
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- Age>=24 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1328
- upper Limit
- 2002
- value
- 1630
- group Id
- OG001
- lower Limit
- 200
- upper Limit
- 398
- value
- 282
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 57
- units
- Participants
- title
- Baseline HIV viral load <=75
- categories
- measurements
- group Id
- OG000
- lower Limit
- 441
- upper Limit
- 1894
- value
- 914
- group Id
- OG001
- lower Limit
- 51
- upper Limit
- 795
- value
- 201
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Baseline HIV viral load >75
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1123
- upper Limit
- 2156
- value
- 1556
- group Id
- OG001
- lower Limit
- 218
- upper Limit
- 590
- value
- 359
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Baseline CD4 <=500
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1178
- upper Limit
- 1967
- value
- 1522
- group Id
- OG001
- lower Limit
- 145
- upper Limit
- 359
- value
- 229
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 42
- units
- Participants
- title
- Baseline CD4 >500
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1040
- upper Limit
- 1857
- value
- 1390
- group Id
- OG001
- lower Limit
- 151
- upper Limit
- 395
- value
- 245
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Nadir CD4 <=350
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1303
- upper Limit
- 2354
- value
- 1752
- group Id
- OG001
- lower Limit
- 186
- upper Limit
- 528
- value
- 313
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Nadir CD4>350
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 66
- units
- Participants
- description
- Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Month 7 visit after enrollment
- id
- OG000
- title
- Month 7 Visit
- description
- Month 24 visit after enrollment
- id
- OG001
- title
- Month 24 Visit
- param Type
- GEOMETRIC_MEAN
- population Description
- Eligible participants who received at least one vaccination and who were sero-negative for HPV 16 at baseline with evaluable serum assessments.
- reporting Status
- POSTED
- time Frame
- at 7 and 24 Months
- title
- Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
- type
- SECONDARY
- unit Of Measure
- mMU/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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