Trial Outcomes & Findings for Preparedness Study - HPV Vaccine (NCT NCT01489527)
NCT ID: NCT01489527
Last Updated: 2015-02-06
Results Overview
HPV type distribution and prevalence of each HPV type at enrollment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
406 participants
Primary outcome timeframe
At Enrollment - 5 Month Enrollment Period
Results posted on
2015-02-06
Participant Flow
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.
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.
Participant milestones
| Measure |
Gardasil Vaccine Administration
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
201
|
|
Overall Study
COMPLETED
|
183
|
175
|
|
Overall Study
NOT COMPLETED
|
22
|
26
|
Reasons for withdrawal
| Measure |
Gardasil Vaccine Administration
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Overall Study
Pregnancy
|
9
|
14
|
|
Overall Study
Participant moved
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Procedures
|
1
|
0
|
|
Overall Study
Not compliant
|
1
|
0
|
Baseline Characteristics
Preparedness Study - HPV Vaccine
Baseline characteristics by cohort
| Measure |
Gardasil Vaccine Administration
n=202 Participants
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
n=200 Participants
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20 years
n=99 Participants
|
20 years
n=107 Participants
|
20 years
n=206 Participants
|
|
Age, Categorical
<=18 years
|
40 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
162 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=99 Participants
|
200 Participants
n=107 Participants
|
402 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
202 participants
n=99 Participants
|
200 participants
n=107 Participants
|
402 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Enrollment - 5 Month Enrollment PeriodPopulation: All treated participants
HPV type distribution and prevalence of each HPV type at enrollment.
Outcome measures
| Measure |
Gardasil Vaccine Administration
n=202 Participants
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
n=200 Participants
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Human Papillomavirus (HPV) Rate
Any HPV Type
|
143 participants
|
136 participants
|
|
Human Papillomavirus (HPV) Rate
Any High-Risk Type
|
106 participants
|
113 participants
|
|
Human Papillomavirus (HPV) Rate
Any Low-Risk Type
|
103 participants
|
97 participants
|
|
Human Papillomavirus (HPV) Rate
HPV6
|
9 participants
|
3 participants
|
|
Human Papillomavirus (HPV) Rate
HPV11
|
2 participants
|
2 participants
|
|
Human Papillomavirus (HPV) Rate
HPV16
|
23 participants
|
32 participants
|
|
Human Papillomavirus (HPV) Rate
HPV18
|
11 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: All treated participants
Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
Outcome measures
| Measure |
Gardasil Vaccine Administration
n=202 Participants
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
n=200 Participants
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Study Compliance Rate
|
91.5 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: At Enrollment - 5 Month Enrollment PeriodPopulation: All treated participants
Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
Outcome measures
| Measure |
Gardasil Vaccine Administration
n=202 Participants
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
n=200 Participants
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV33
|
25 percentage of participants
|
30 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV6
|
73 percentage of participants
|
73 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV11
|
45 percentage of participants
|
47 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV16
|
32 percentage of participants
|
37 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV18
|
46 percentage of participants
|
41 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV31
|
31 percentage of participants
|
38 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV45
|
15 percentage of participants
|
18 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV52
|
36 percentage of participants
|
35 percentage of participants
|
|
Percentage of Participants Who Were Seropositive by HPV Type
HPV58
|
36 percentage of participants
|
36 percentage of participants
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: Participants who were randomized to Gardasil and received all 3 doses of Gardasil
Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
Outcome measures
| Measure |
Gardasil Vaccine Administration
n=179 Participants
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: All treated participants
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.
Outcome measures
| Measure |
Gardasil Vaccine Administration
n=202 Participants
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
n=200 Participants
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
HPV31
|
82 percentage of participants
|
39 percentage of participants
|
|
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
HPV33
|
56 percentage of participants
|
34 percentage of participants
|
|
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
HPV45
|
42 percentage of participants
|
19 percentage of participants
|
|
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
HPV58
|
69 percentage of participants
|
38 percentage of participants
|
Adverse Events
Gardasil Vaccine Administration
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo Administration
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gardasil Vaccine Administration
n=202 participants at risk
Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
|
Placebo Administration
n=200 participants at risk
Placebo injected intramuscularly into the deltoid or thigh muscle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
1.0%
2/200 • Number of events 2 • 1 year, 6 months
|
|
Gastrointestinal disorders
Anal mucositis
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
General disorders
Flu like symptoms
|
1.5%
3/202 • Number of events 3 • 1 year, 6 months
|
1.0%
2/200 • Number of events 2 • 1 year, 6 months
|
|
General disorders
Injection site reaction
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/202 • 1 year, 6 months
|
1.0%
2/200 • Number of events 2 • 1 year, 6 months
|
|
General disorders
Pain
|
7.9%
16/202 • Number of events 18 • 1 year, 6 months
|
2.5%
5/200 • Number of events 5 • 1 year, 6 months
|
|
Immune system disorders
Allergic reaction
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Immune system disorders
Immune system disorders - Other
|
0.99%
2/202 • Number of events 2 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
Lip infection
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
Sinusitis
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Infections and infestations
Urinary tract infection
|
3.5%
7/202 • Number of events 7 • 1 year, 6 months
|
6.0%
12/200 • Number of events 12 • 1 year, 6 months
|
|
Infections and infestations
Vaginal infection
|
8.9%
18/202 • Number of events 18 • 1 year, 6 months
|
8.0%
16/200 • Number of events 17 • 1 year, 6 months
|
|
Infections and infestations
Vulval infection
|
0.99%
2/202 • Number of events 2 • 1 year, 6 months
|
1.0%
2/200 • Number of events 2 • 1 year, 6 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
Burn
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
0.99%
2/202 • Number of events 2 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Investigations
Weight loss
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Nervous system disorders
Dizziness
|
3.0%
6/202 • Number of events 6 • 1 year, 6 months
|
2.0%
4/200 • Number of events 4 • 1 year, 6 months
|
|
Nervous system disorders
Headache
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
2.5%
5/200 • Number of events 5 • 1 year, 6 months
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Nervous system disorders
Lethargy
|
2.0%
4/202 • Number of events 4 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.50%
1/202 • Number of events 2 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.99%
2/202 • Number of events 2 • 1 year, 6 months
|
1.0%
2/200 • Number of events 2 • 1 year, 6 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
1.5%
3/200 • Number of events 3 • 1 year, 6 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.5%
3/202 • Number of events 3 • 1 year, 6 months
|
2.5%
5/200 • Number of events 5 • 1 year, 6 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.50%
1/202 • Number of events 2 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/202 • 1 year, 6 months
|
1.0%
2/200 • Number of events 3 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/202 • 1 year, 6 months
|
1.5%
3/200 • Number of events 3 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/202 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
1.0%
2/200 • Number of events 2 • 1 year, 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.50%
1/200 • Number of events 1 • 1 year, 6 months
|
|
Vascular disorders
Hypertension
|
0.50%
1/202 • Number of events 1 • 1 year, 6 months
|
0.00%
0/200 • 1 year, 6 months
|
Additional Information
Anna R. Giuliano, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-6820
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place