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Preparedness Study - HPV Vaccine

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ClinicalTrials.gov Identifier: NCT01489527
Recruitment Status : Completed
First Posted : December 9, 2011
Results First Posted : January 12, 2015
Last Update Posted : February 6, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Sexual Transmission of Infection
Interventions Biological: Gardasil Vaccine
Other: Placebo
Enrollment 406
Recruitment Details 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 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.
Arm/Group Title Gardasil Vaccine Administration Placebo Administration
Hide Arm/Group Description Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle. Placebo injected intramuscularly into the deltoid or thigh muscle.
Period Title: Overall Study
Started 205 201
Completed 183 175
Not Completed 22 26
Reason Not Completed
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
Arm/Group Title Gardasil Vaccine Administration Placebo Administration Total
Hide Arm/Group Description Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle. Placebo injected intramuscularly into the deltoid or thigh muscle. Total of all reporting groups
Overall Number of Baseline Participants 202 200 402
Hide Baseline Analysis Population Description
All treated participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 202 participants 200 participants 402 participants
20
(16 to 24)
20
(16 to 24)
20
(16 to 24)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 200 participants 402 participants
<=18 years
40
  19.8%
46
  23.0%
86
  21.4%
Between 18 and 65 years
162
  80.2%
154
  77.0%
316
  78.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 200 participants 402 participants
Female
202
 100.0%
200
 100.0%
402
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 202 participants 200 participants 402 participants
202 200 402
1.Primary Outcome
Title Human Papillomavirus (HPV) Rate
Hide Description HPV type distribution and prevalence of each HPV type at enrollment.
Time Frame At Enrollment - 5 Month Enrollment Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Gardasil Vaccine Administration Placebo Administration
Hide Arm/Group Description:
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
Placebo injected intramuscularly into the deltoid or thigh muscle.
Overall Number of Participants Analyzed 202 200
Measure Type: Number
Unit of Measure: participants
Any HPV Type 143 136
Any High-Risk Type 106 113
Any Low-Risk Type 103 97
HPV6 9 3
HPV11 2 2
HPV16 23 32
HPV18 11 14
2.Secondary Outcome
Title Study Compliance Rate
Hide Description Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
Time Frame 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Gardasil Vaccine Administration Placebo Administration
Hide Arm/Group Description:
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
Placebo injected intramuscularly into the deltoid or thigh muscle.
Overall Number of Participants Analyzed 202 200
Measure Type: Number
Unit of Measure: percentage of participants
91.5 87.5
3.Secondary Outcome
Title Percentage of Participants Who Were Seropositive by HPV Type
Hide Description Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
Time Frame At Enrollment - 5 Month Enrollment Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Gardasil Vaccine Administration Placebo Administration
Hide Arm/Group Description:
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
Placebo injected intramuscularly into the deltoid or thigh muscle.
Overall Number of Participants Analyzed 202 200
Measure Type: Number
Unit of Measure: percentage of participants
HPV6 73 73
HPV11 45 47
HPV16 32 37
HPV18 46 41
HPV31 31 38
HPV33 25 30
HPV45 15 18
HPV52 36 35
HPV58 36 36
4.Secondary Outcome
Title Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
Hide Description Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
Time Frame 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized to Gardasil and received all 3 doses of Gardasil
Arm/Group Title Gardasil Vaccine Administration Placebo Administration
Hide Arm/Group Description:
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
Placebo injected intramuscularly into the deltoid or thigh muscle.
Overall Number of Participants Analyzed 179 0
Measure Type: Number
Unit of Measure: percentage of participants
100
5.Secondary Outcome
Title Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
Hide Description The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.
Time Frame 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Gardasil Vaccine Administration Placebo Administration
Hide Arm/Group Description:
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
Placebo injected intramuscularly into the deltoid or thigh muscle.
Overall Number of Participants Analyzed 202 200
Measure Type: Number
Unit of Measure: percentage of participants
HPV31 82 39
HPV33 56 34
HPV45 42 19
HPV58 69 38
Time Frame 1 year, 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gardasil Vaccine Administration Placebo Administration
Hide Arm/Group Description Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle. Placebo injected intramuscularly into the deltoid or thigh muscle.
All-Cause Mortality
Gardasil Vaccine Administration Placebo Administration
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gardasil Vaccine Administration Placebo Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/202 (0.00%)      0/200 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gardasil Vaccine Administration Placebo Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/202 (29.21%)      62/200 (31.00%)    
Gastrointestinal disorders     
Abdominal pain  1  1/202 (0.50%)  1 2/200 (1.00%)  2
Anal mucositis  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Gastritis  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Gastrointestinal disorders - Other  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Nausea  1  1/202 (0.50%)  1 1/200 (0.50%)  1
Stomach pain  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Vomiting  1  1/202 (0.50%)  1 0/200 (0.00%)  0
General disorders     
Flu like symptoms  1  3/202 (1.49%)  3 2/200 (1.00%)  2
Injection site reaction  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Non-cardiac chest pain  1  0/202 (0.00%)  0 2/200 (1.00%)  2
Pain  1  16/202 (7.92%)  18 5/200 (2.50%)  5
Immune system disorders     
Allergic reaction  1  1/202 (0.50%)  1 1/200 (0.50%)  1
Immune system disorders - Other  1  2/202 (0.99%)  2 1/200 (0.50%)  1
Infections and infestations     
Lip infection  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Pelvic infection  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Sinusitis  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Urinary tract infection  1  7/202 (3.47%)  7 12/200 (6.00%)  12
Vaginal infection  1  18/202 (8.91%)  18 16/200 (8.00%)  17
Vulval infection  1  2/202 (0.99%)  2 2/200 (1.00%)  2
Wound infection  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Injury, poisoning and procedural complications     
Burn  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Fracture  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Injury, poisoning and procedural complications - Other  1  2/202 (0.99%)  2 1/200 (0.50%)  1
Investigations     
Weight loss  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Nervous system disorders     
Dizziness  1  6/202 (2.97%)  6 4/200 (2.00%)  4
Headache  1  1/202 (0.50%)  1 5/200 (2.50%)  5
Hypersomnia  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Lethargy  1  4/202 (1.98%)  4 0/200 (0.00%)  0
Renal and urinary disorders     
Urinary tract pain  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Reproductive system and breast disorders     
Dyspareunia  1  1/202 (0.50%)  2 0/200 (0.00%)  0
Irregular menstruation  1  2/202 (0.99%)  2 2/200 (1.00%)  2
Reproductive system and breast disorders - Other  1  1/202 (0.50%)  1 3/200 (1.50%)  3
Vaginal discharge  1  3/202 (1.49%)  3 5/200 (2.50%)  5
Vaginal dryness  1  1/202 (0.50%)  2 0/200 (0.00%)  0
Vaginal hemorrhage  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Vaginal inflammation  1  0/202 (0.00%)  0 2/200 (1.00%)  3
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  0/202 (0.00%)  0 3/200 (1.50%)  3
Respiratory, thoracic and mediastinal disorders - Other  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Sinus disorder  1  1/202 (0.50%)  1 1/200 (0.50%)  1
Sore throat  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Skin and subcutaneous tissue disorders     
Rash acneiform  1  0/202 (0.00%)  0 1/200 (0.50%)  1
Skin and subcutaneous tissue disorders - Other  1  1/202 (0.50%)  1 2/200 (1.00%)  2
Surgical and medical procedures     
Surgical and medical procedures - Other  1  1/202 (0.50%)  1 1/200 (0.50%)  1
Vascular disorders     
Hypertension  1  1/202 (0.50%)  1 0/200 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The EVRI Trial had a short duration with limited follow-up time; therefore, clinical efficacy in reducing HIV acquisition cannot be assessed.
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
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 ( Other Grant/Funding Number: Merck )
First Submitted: December 8, 2011
First Posted: December 9, 2011
Results First Submitted: January 5, 2015
Results First Posted: January 12, 2015
Last Update Posted: February 6, 2015