Trial Outcomes & Findings for Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection (NCT NCT00513526)
NCT ID: NCT00513526
Last Updated: 2023-11-14
Results Overview
Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
All study visits
Results posted on
2023-11-14
Participant Flow
Participant milestones
| Measure |
Gardasil
Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
|
|---|---|
|
Overall Study
STARTED
|
109
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
Baseline characteristics by cohort
| Measure |
Gardasil
n=109 Participants
Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All study visitsPopulation: Intention to treat (i.e., received at least one dose of the vaccine)
Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine
Outcome measures
| Measure |
Gardasil
n=109 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine
|
0 participants
Interval to 0.0275
Upper bound of confidence interval. No participant experienced grade 3 or greater events attributable to the vaccine
|
PRIMARY outcome
Timeframe: Week 28Population: Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.
Outcome measures
| Measure |
Gardasil
n=60 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline
|
0.98 proportion of participants
Interval 0.92 to
Lower one-sided 95% confidence interval
|
PRIMARY outcome
Timeframe: Week 28Population: Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.
Outcome measures
| Measure |
Gardasil
n=68 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline
|
0.99 proportion of participants
Interval 0.93 to
Lower one-sided 95% confidence interval
|
PRIMARY outcome
Timeframe: Week 28Population: Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.
Outcome measures
| Measure |
Gardasil
n=62 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline
|
1.00 proportion of participants
Interval 0.95 to
Lower one-sided 95% confidence interval
|
PRIMARY outcome
Timeframe: Week 28Population: Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.
Outcome measures
| Measure |
Gardasil
n=77 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline
|
0.95 proportion of participants
Interval 0.89 to
Lower one-sided 95% confidence interval
|
SECONDARY outcome
Timeframe: Week 0, 4, 12, 28Population: Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.
CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.
Outcome measures
| Measure |
Gardasil
n=109 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
Longitudinal Changes in CD4+ Cell Count From Baseline
Change from baseline at week 4
|
11 cells/uL
Interval -81.0 to 71.0
|
|
Longitudinal Changes in CD4+ Cell Count From Baseline
Change from baseline at week 12
|
9 cells/uL
Interval -56.0 to 70.0
|
|
Longitudinal Changes in CD4+ Cell Count From Baseline
Change from baseline at week 28
|
1 cells/uL
Interval -72.0 to 71.0
|
SECONDARY outcome
Timeframe: Week 0, 4, 12, 28Population: Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.
Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.
Outcome measures
| Measure |
Gardasil
n=103 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Baseline
|
38 copies/ml
Interval 24.0 to 94.0
|
|
Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Change at 4 weeks from the baseline
|
0 copies/ml
Interval -1.0 to 0.0
|
|
Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Change at 12 weeks from the baseline
|
0 copies/ml
Interval -1.0 to 0.0
|
|
Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Change at 28 weeks from the baseline
|
0 copies/ml
Interval -1.0 to 12.0
|
SECONDARY outcome
Timeframe: weeks 0, 28, and 76Population: Intent to treat population, includes all participants who received at least one dose of vaccine
HPV antibody titers to type 6 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Outcome measures
| Measure |
Gardasil
n=109 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Baseline
|
76 Milli-Merck units/mL
Interval 58.0 to 98.0
|
|
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 28
|
933 Milli-Merck units/mL
Interval 525.0 to 1657.0
|
|
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 76
|
613 Milli-Merck units/mL
Interval 393.0 to 959.0
|
|
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Baseline
|
5 Milli-Merck units/mL
Interval 5.0 to 7.0
|
|
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 28
|
336 Milli-Merck units/mL
Interval 242.0 to 467.0
|
|
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 76
|
146 Milli-Merck units/mL
Interval 115.0 to 186.0
|
SECONDARY outcome
Timeframe: weeks 0, 28, and 76Population: Intent to treat population, includes all participants who received at least one dose of vaccine
HPV antibody titers to type 11 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Outcome measures
| Measure |
Gardasil
n=109 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Baseline
|
53 Milli-Merck units/mL
Interval 42.0 to 66.0
|
|
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 28
|
1536 Milli-Merck units/mL
Interval 1089.0 to 2168.0
|
|
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 76
|
797 Milli-Merck units/mL
Interval 520.0 to 1221.0
|
|
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Baseline
|
5 Milli-Merck units/mL
Interval 5.0 to 6.0
|
|
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 28
|
503 Milli-Merck units/mL
Interval 385.0 to 658.0
|
|
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 76
|
196 Milli-Merck units/mL
Interval 151.0 to 253.0
|
SECONDARY outcome
Timeframe: weeks 0, 28, and 76Population: Intent to treat population, includes all participants who received at least one dose of vaccine
HPV antibody titers to type 16 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Outcome measures
| Measure |
Gardasil
n=109 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Baseline
|
83 Milli-Merck units/mL
Interval 59.0 to 117.0
|
|
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 28
|
2005 Milli-Merck units/mL
Interval 1215.0 to 3309.0
|
|
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 76
|
1225 Milli-Merck units/mL
Interval 779.0 to 1926.0
|
|
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Baseline
|
6 Milli-Merck units/mL
Interval 5.0 to 6.0
|
|
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 28
|
1001 Milli-Merck units/mL
Interval 745.0 to 1346.0
|
|
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 76
|
287 Milli-Merck units/mL
Interval 202.0 to 408.0
|
SECONDARY outcome
Timeframe: weeks 0, 28, and 76Population: Intent to treat population, includes all participants who received at least one dose of vaccine
HPV antibody titers to type 18 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Outcome measures
| Measure |
Gardasil
n=109 Participants
The single arm study is performed among HIV infected adult men satisfying the study eligibility criteria, including either PCR-negative for HPV 16 and/or HPV 18, or up to 20 subjects with PCR-positive for HPV 16 and HPV 18 each. Subjects are excluded if they have an anal cytology showing high-grade intraepithelial lesion(s) (HSIL), atypical squamous cells of undetermined significance (ASCUS) suggestive of HSIL or cytology suggestive of carcinoma. Subjects with a cytological result that is normal, ASCUS or low grade intraepithelial lesion(s) (LSIL) are eligible if subsequent anal biopsies obtained during high-resolution anoscopy at pre-entry show no evidence of HGAIN or squamous cell carcinoma. At study entry, subjects will give samples for HPV DNA PCR, and HPV type-specific serologies. Subjects will receive the HPV vaccine on Day 1, Week 8 and Week 24. Subsequently, subjects will be seen for study visits through 18 months after entry (12 months after vaccination). HPV DNA PCR, liquid based anal cytology, high resolution anoscopy with biopsy and HPV serologies (types 6, 11, 16 and 18) will be obtained during study follow-up
|
|---|---|
|
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Baseline
|
53 Milli-Merck units/mL
Interval 39.0 to 73.0
|
|
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 28
|
765 Milli-Merck units/mL
Interval 446.0 to 1313.0
|
|
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seropositive Group at Week 76
|
370 Milli-Merck units/mL
Interval 202.0 to 679.0
|
|
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Baseline
|
5 Milli-Merck units/mL
Interval 5.0 to 6.0
|
|
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 28
|
181 Milli-Merck units/mL
Interval 138.0 to 238.0
|
|
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Seronegative Group at Week 76
|
38 Milli-Merck units/mL
Interval 27.0 to 54.0
|
SECONDARY outcome
Timeframe: Weeks 0, 28 and 76Population: Samples for this outcome measure were not analyzed due to loss of funding for the central lab.
Outcome measures
Outcome data not reported
Adverse Events
Gardasil
Serious events: 5 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gardasil
n=109 participants at risk
Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
|
|---|---|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __)
|
0.92%
1/109 • Number of events 1
|
|
General disorders
Pain / Head/Headache
|
0.92%
1/109 • Number of events 1
|
|
General disorders
Pain
|
0.92%
1/109 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specifiy, __)
|
0.92%
1/109 • Number of events 2
|
|
Infections and infestations
Infection with Normal ANC or Grade 1 or 2 Neutrophils/Bone (Osteomyelitis)
|
0.92%
1/109 • Number of events 1
|
Other adverse events
| Measure |
Gardasil
n=109 participants at risk
Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
6/109 • Number of events 6
|
|
General disorders
Fatigue (Asthenia, Lethargy, Malaise)
|
5.5%
6/109 • Number of events 6
|
|
Infections and infestations
Infection - Other (Specify, __)
|
7.3%
8/109 • Number of events 9
|
|
Infections and infestations
Infection with Normal ANC or Grade 1 or 2 Neutrophils / Upper Airway NOS
|
9.2%
10/109 • Number of events 11
|
|
Infections and infestations
Infection with Unknown ANC / Upper Airway NOS
|
7.3%
8/109 • Number of events 9
|
|
Injury, poisoning and procedural complications
Injection Site Reaction / Extravasation Changes
|
32.1%
35/109 • Number of events 62
|
|
General disorders
Pain - Other (Specifiy, __)
|
5.5%
6/109 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place