Trial Outcomes & Findings for Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women (NCT NCT00786409)

NCT ID: NCT00786409

Last Updated: 2018-02-15

Results Overview

Percent Seropositive

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2018-02-15

Participant Flow

Participant milestones

Measure	Gardasil Vaccine 0.5 ml Gardasil vaccine at months 0, 2, and 6
Overall Study STARTED	27
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Gardasil Vaccine 0.5 ml Gardasil vaccine at months 0, 2, and 6
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	2
Overall Study Pregnancy	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Baseline characteristics by cohort

Measure	Gardasil Vaccine n=27 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Age, Continuous	20.5 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

Percent Seropositive

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 6 Seroconversion	93.8 percentage of participants Interval 69.8 to 99.8

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 6 GMT	427.0 mMu/ml Interval 203.4 to 903.4

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

% Seropositive

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 11 Seroconversion	100 percentage of participants Interval 79.4 to 100.0

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 11 GMT	596.7 mMu/ml Interval 303.6 to 1173.2

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

% Seropositive

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 16 Seroconversion	100 percentage of participants Interval 79.4 to 100.0

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 16 GMT	2263.2 mMu/ml Interval 1019.3 to 5024.8

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

% Seropositive

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 18 Seroconversion	93.8 percentage of participants Interval 69.8 to 99.8

PRIMARY outcome

Timeframe: 7 months

Population: 4 patients did not have month 7 samples available for analysis

Geometric mean titre in milli-Merck units per ml (mMu/ml)

Outcome measures

Measure	Gardasil Vaccine n=16 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Anti-HPV 18 GMT	331.9 mMu/ml Interval 159.8 to 689.2

PRIMARY outcome

Timeframe: 7 months

Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.

Outcome measures

Measure	Gardasil Vaccine n=20 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
SLEDAI Change Score	-1.65 units on a scale Interval -2.85 to -0.44

SECONDARY outcome

Timeframe: 7 months

Population: 8 patients were negative for anti-RNP at entry

Outcome measures

Measure	Gardasil Vaccine n=8 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP	0 Participants

SECONDARY outcome

Timeframe: 7 months

Population: 13 patients were Smith negative at entry.

Outcome measures

Measure	Gardasil Vaccine n=13 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)	0 Participants

SECONDARY outcome

Timeframe: 7 months

Population: 17 patients were Lupus anticoagulant negative at entry.

Outcome measures

Measure	Gardasil Vaccine n=17 Participants 0.5 ml Gardasil vaccine at months 0, 2, and 6
Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)	2 Participants

Adverse Events

Gardasil Vaccine

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gardasil Vaccine n=27 participants at risk 0.5 ml Gardasil vaccine at months 0, 2, and 6
Renal and urinary disorders Progression of Class IV Nephritis to Renal Failure	7.4% 2/27 • 18 months

Other adverse events

Measure	Gardasil Vaccine n=27 participants at risk 0.5 ml Gardasil vaccine at months 0, 2, and 6
Musculoskeletal and connective tissue disorders Arthralgia	18.5% 5/27 • 18 months
Skin and subcutaneous tissue disorders Rash	14.8% 4/27 • 18 months
Respiratory, thoracic and mediastinal disorders Pleurisy	7.4% 2/27 • 18 months
Gastrointestinal disorders Constipation	3.7% 1/27 • 18 months
Nervous system disorders Peripheral neuropathy	3.7% 1/27 • 18 months
Renal and urinary disorders Urinary tract infection	3.7% 1/27 • 18 months

Additional Information

Linda Wagner-Weinter, MD

University of Chicago

Phone: 773-702-2245

Email: lww@uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place