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Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

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ClinicalTrials.gov Identifier: NCT00513526
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : July 26, 2011
Last Update Posted : September 17, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infection
Precancerous Condition
Intervention Biological: Gardasil
Enrollment 112

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gardasil
Hide Arm/Group Description Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
Period Title: Overall Study
Started 109
Completed 92
Not Completed 17
Arm/Group Title Gardasil
Hide Arm/Group Description Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
Overall Number of Baseline Participants 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
<=18 years
0
   0.0%
Between 18 and 65 years
109
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants
43.4  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Female
0
   0.0%
Male
109
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants
109
1.Primary Outcome
Title Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine
Hide Description [Not Specified]
Time Frame All study visits
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (i.e., received at least one dose of the vaccine)
Arm/Group Title Gardasil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 109
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gardasil
Hide Arm/Group Description:
Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.98 [1] 
(0.92 to NA)
[1]
Lower one-sided 95% confidence interval
3.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gardasil
Hide Arm/Group Description:
Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.99 [1] 
(0.93 to NA)
[1]
Lower one-sided 95% confidence interval
4.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gardasil
Hide Arm/Group Description:
Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
Overall Number of Participants Analyzed 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
1.00 [1] 
(0.95 to NA)
[1]
Lower one-sided 95% confidence interval
5.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gardasil
Hide Arm/Group Description:
Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
Overall Number of Participants Analyzed 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.95 [1] 
(0.89 to NA)
[1]
Lower one-sided 95% confidence interval
6.Secondary Outcome
Title Longitudinal Changes in CD4+ Cell Count From Baseline
Hide Description CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.
Time Frame Week 0, 4, 12, 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gardasil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 109
Median (Inter-Quartile Range)
Unit of Measure: cells/uL
Change from baseline at week 4
11
(-81 to 71)
Change from baseline at week 12
9
(-56 to 70)
Change from baseline at week 28
1
(-72 to 71)
7.Secondary Outcome
Title Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Hide Description Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.
Time Frame Week 0, 4, 12, 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gardasil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 109
Median (Inter-Quartile Range)
Unit of Measure: copies/ml
Change from baseline at week 4
0
(0 to 0)
Change from baseline at week 12
0
(0 to 0)
Change from baseline at week 28
0
(0 to 0)
8.Secondary Outcome
Title HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Hide Description [Not Specified]
Time Frame weeks 0, 28, and 76
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, includes all participants who received at least one dose of vaccine
Arm/Group Title Gardasil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milli-Merck units/mL
Seropositive Group at Baseline
76
(58 to 98)
Seropositive Group at Week 28
933
(525 to 1657)
Seropositive Group at Week 76
613
(393 to 959)
Seronegative Group at Baseline
5
(5 to 7)
Seronegative Group at Week 28
336
(242 to 467)
Seronegative Group at Week 76
146
(115 to 186)
9.Secondary Outcome
Title HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Hide Description [Not Specified]
Time Frame weeks 0, 28, and 76
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, includes all participants who received at least one dose of vaccine
Arm/Group Title Gardasil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milli-Merck units/mL
Seropositive Group at Baseline
53
(42 to 66)
Seropositive Group at Week 28
1536
(1089 to 2168)
Seropositive Group at Week 76
797
(520 to 1221)
Seronegative Group at Baseline
5
(5 to 6)
Seronegative Group at Week 28
503
(385 to 658)
Seronegative Group at Week 76
196
(151 to 253)
10.Secondary Outcome
Title HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Hide Description [Not Specified]
Time Frame weeks 0, 28, and 76
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, includes all participants who received at least one dose of vaccine
Arm/Group Title Gardasil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milli-Merck units/mL
Seropositive Group at Baseline
83
(59 to 117)
Seropositive Group at Week 28
2005
(1215 to 3309)
Seropositive Group at Week 76
1225
(779 to 1926)
Seronegative Group at Baseline
6
(5 to 6)
Seronegative Group at Week 28
1001
(745 to 1346)
Seronegative Group at Week 76
287
(202 to 408)
11.Secondary Outcome
Title HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Hide Description [Not Specified]
Time Frame weeks 0, 28, and 76
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, includes all participants who received at least one dose of vaccine
Arm/Group Title Gardasil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milli-Merck units/mL
Seropositive Group at Baseline
53
(39 to 73)
Seropositive Group at Week 28
765
(446 to 1313)
Seropositive Group at Week 76
370
(202 to 679)
Seronegative Group at Baseline
5
(5 to 6)
Seronegative Group at Week 28
181
(138 to 238)
Seronegative Group at Week 76
38
(27 to 54)
12.Secondary Outcome
Title Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series
Hide Description [Not Specified]
Time Frame Weeks 0, 28 and 76
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Samples for this outcome measure were not analyzed due to loss of funding for the central lab.
Arm/Group Title Gardasil
Hide Arm/Group Description:
Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gardasil
Hide Arm/Group Description Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
All-Cause Mortality
Gardasil
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gardasil
Affected / at Risk (%) # Events
Total   5/109 (4.59%)    
General disorders   
Pain / Head/Headache * 1  1/109 (0.92%)  1
Pain * 1  1/109 (0.92%)  1
Hepatobiliary disorders   
Hepatobiliary/Pancreas - Other (Specify, __) * 1  1/109 (0.92%)  1
Infections and infestations   
Infection with Normal ANC or Grade 1 or 2 Neutrophils/Bone (Osteomyelitis) * 1  1/109 (0.92%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other (Specifiy, __) * 1  1/109 (0.92%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gardasil
Affected / at Risk (%) # Events
Total   56/109 (51.38%)    
General disorders   
Fatigue (Asthenia, Lethargy, Malaise) * 1  6/109 (5.50%)  6
Pain - Other (Specifiy, __) * 1  6/109 (5.50%)  6
Infections and infestations   
Infection - Other (Specify, __) * 1  8/109 (7.34%)  9
Infection with Normal ANC or Grade 1 or 2 Neutrophils / Upper Airway NOS * 2  10/109 (9.17%)  11
Infection with Unknown ANC / Upper Airway NOS * 1  8/109 (7.34%)  9
Injury, poisoning and procedural complications   
Injection Site Reaction / Extravasation Changes * 1  35/109 (32.11%)  62
Respiratory, thoracic and mediastinal disorders   
Cough * 1  6/109 (5.50%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Group Statistician
Organization: AMC
Phone: 501-526-6712
Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00513526     History of Changes
Other Study ID Numbers: AMC-052
CDR0000559149 ( Other Identifier: NCI )
U01CA121947 ( U.S. NIH Grant/Contract )
First Submitted: August 6, 2007
First Posted: August 8, 2007
Results First Submitted: June 28, 2011
Results First Posted: July 26, 2011
Last Update Posted: September 17, 2015