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Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01461096
First received: October 26, 2011
Last updated: December 14, 2016
Last verified: December 2016
Results First Received: December 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Biological: Quadrivalent HPV Vaccine
Biological: Placebo Vaccine for Male Participants Only
Biological: Placebo Vaccine for Female Participants Only

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In less than 18 months, the full study cohort of 575 participants (472 males and 103 females) were enrolled and randomized in A5298. The first participant was randomized on March 8, 2012 and the last was randomized on August 23, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Quadrivalent HPV Vaccine

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.


Participant Flow:   Overall Study
    Quadrivalent HPV Vaccine   Placebo Vaccine
STARTED   288   287 
Did Not Start Treatment   0   1 [1] 
COMPLETED [2]   226   226 
NOT COMPLETED   62   61 
Death                3                6 
Severe debilitation, unable to continue                1                1 
Subj not able to get to clinic                15                13 
Site is closing                27                30 
Withdrawal by Subject                5                3 
Subj not willing to adhere to reqs                3                4 
Lost to Follow-up                8                4 
[1] Randomized but never started treatment and was discontinued from the study
[2] Unexpected closure of study. Completed study requirements up to the time of unexpected closure.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants randomized who had results for the respective baseline measure available. The numbers of participants for each measure are shown below.

Reporting Groups
  Description
Quadrivalent HPV Vaccine

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Total Total of all reporting groups

Baseline Measures
   Quadrivalent HPV Vaccine   Placebo Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 288   287   575 
Age 
[Units: Years]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 288   287   575 
   47 
 (40 to 52) 
 48 
 (42 to 53) 
 47 
 (41 to 53) 
Gender 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 288   287   575 
Female      52  18.1%      51  17.8%      103  17.9% 
Male      236  81.9%      236  82.2%      472  82.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 288   287   575 
White Non-Hispanic      125  43.4%      136  47.4%      261  45.4% 
Black Non-Hispanic      91  31.6%      89  31.0%      180  31.3% 
Hispanic (Regardless of Race)      63  21.9%      54  18.8%      117  20.3% 
Asian, Pacific Islander      5   1.7%      7   2.4%      12   2.1% 
American Indian, Alaskan Native      2   0.7%      0   0.0%      2   0.3% 
More than one race      2   0.7%      1   0.3%      3   0.5% 
Presence of HGAIN at entry 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 288   287   575 
HGAIN      95  33.0%      92  32.1%      187  32.5% 
No HGAIN      193  67.0%      195  67.9%      388  67.5% 
IV drug history 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 288   287   575 
Never      270  93.8%      259  90.2%      529  92.0% 
Previously      18   6.3%      28   9.8%      46   8.0% 
HIV RNA results (copies/mL) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 288   287   575 
<50      226  78.5%      244  85.0%      470  81.7% 
50-<200      23   8.0%      15   5.2%      38   6.6% 
200-<500      13   4.5%      4   1.4%      17   3.0% 
500-<1000      3   1.0%      4   1.4%      7   1.2% 
1000-<10000      10   3.5%      6   2.1%      16   2.8% 
>=10000      7   2.4%      9   3.1%      16   2.8% 
Missing      6   2.1%      5   1.7%      11   1.9% 
Lowest documented CD4 count [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 260   255   515 
   254 
 (105 to 373) 
 259 
 (119 to 419) 
 255 
 (110 to 403) 
[1] Row population differs from the overall due to Missing
Absolute CD4 count [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 285   284   569 
   598 
 (438 to 761) 
 614 
 (435 to 803) 
 602 
 (436 to 767) 
[1] Row population differs from the overall due to Missing
Percent CD4 [1] 
[Units: %]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 285   284   569 
   32 
 (25.00 to 38.80) 
 31 
 (23.90 to 37.90) 
 31.70 
 (25 to 38) 
[1] Row population differs from the overall due to Missing


  Outcome Measures
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1.  Primary:   Time to the First New Persistent Infection of HPV 6, 11, 16, or 18   [ Time Frame: From baseline to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study ]

2.  Secondary:   Number of Participants With Biopsy-proven High-grade Anal Intraepithelial Neoplasia (HGAIN) Occurrences and Reoccurrences After Week 52   [ Time Frame: From Week 52 to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study ]

3.  Secondary:   Number of Participants With Anal Cytological Abnormality Occurrences   [ Time Frame: At baseline, Week 52, Week 104 and Week 156 ]

4.  Secondary:   Number of Participants With Grade 3 or 4 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine, as Determined by the Local Investigator   [ Time Frame: From baseline to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study ]

5.  Secondary:   Time to First New Persistent Oral HPV Infection of Vaccine Types Detected From Oral Rinse   [ Time Frame: From baseline to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01461096     History of Changes
Other Study ID Numbers: A5298
11798 ( Registry Identifier: DAIDS ES Registry Number )
Study First Received: October 26, 2011
Results First Received: December 14, 2016
Last Updated: December 14, 2016