Preparedness Study - HPV Vaccine

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01489527
First received: December 8, 2011
Last updated: January 21, 2015
Last verified: January 2015
Results First Received: January 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Sexual Transmission of Infection
Interventions: Biological: Gardasil Vaccine
Other: Placebo

  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
Women residing in the Western Cape, South Africa were enrolled from November 2012 to July 2013 in a preparedness study. Participants were recruited from the Kraaifontein day hospital and the Bloekombos primary health care clinic by community workers and through word of mouth, flyers, and brochures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4 of the 406 participants randomized had a false HIV negative test result, reducing the participants to 202 in the Gardasil Arm and 200 in the Placebo Arm.

Reporting Groups
  Description
Gardasil Vaccine Administration Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
Placebo Administration Placebo injected intramuscularly into the deltoid or thigh muscle.

Participant Flow:   Overall Study
    Gardasil Vaccine Administration     Placebo Administration  
STARTED     205     201  
COMPLETED     183     175  
NOT COMPLETED     22     26  
Pregnancy                 9                 14  
Participant moved                 6                 7  
Withdrawal by Subject                 0                 4  
Lost to Follow-up                 5                 1  
Procedures                 1                 0  
Not compliant                 1                 0  



  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 treated participants

Reporting Groups
  Description
Gardasil Vaccine Administration Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
Placebo Administration Placebo injected intramuscularly into the deltoid or thigh muscle.
Total Total of all reporting groups

Baseline Measures
    Gardasil Vaccine Administration     Placebo Administration     Total  
Number of Participants  
[units: participants]
  202     200     402  
Age  
[units: years]
Median ( Full Range )
  20  
  ( 16 to 24 )  
  20  
  ( 16 to 24 )  
  20  
  ( 16 to 24 )  
Age  
[units: participants]
     
<=18 years     40     46     86  
Between 18 and 65 years     162     154     316  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     202     200     402  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
South Africa     202     200     402  



  Outcome Measures
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1.  Primary:   Human Papillomavirus (HPV) Rate   [ Time Frame: At Enrollment - 5 Month Enrollment Period ]

2.  Secondary:   Study Compliance Rate   [ Time Frame: 18 Months ]

3.  Secondary:   Percentage of Participants Who Were Seropositive by HPV Type   [ Time Frame: At Enrollment - 5 Month Enrollment Period ]

4.  Secondary:   Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18   [ Time Frame: 18 Months ]

5.  Secondary:   Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58   [ Time Frame: 18 Months ]


  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
The EVRI Trial had a short duration with limited follow-up time; therefore, clinical efficacy in reducing HIV acquisition cannot be assessed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Anna R. Giuliano, Ph.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-6820
e-mail: anna.giuliano@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01489527     History of Changes
Other Study ID Numbers: MCC-16685, IISP ID 39582
Study First Received: December 8, 2011
Results First Received: January 5, 2015
Last Updated: January 21, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration