We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix TM) in HIV Infected Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586339
First Posted: January 4, 2008
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Interventions: Biological: Cervarix TM
Biological: Placebo Control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HIV+ subjects were randomised to receive either Cervarix or Aluminium Hydroxide vaccines; HIV- subjects were not randomised and all received Cervarix vaccine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolment was staggered as follows: 1) Enrolment of Human immunodeficiency virus positive (HIV+) subjects with cluster of differentiation 4 (CD4+) cell count >200 cells per cubic millimeter (cells/mm^3) and HIV negative (HIV-) subjects (up to 30 subjects) for blinded safety evaluation; 2) Enrolment of remaining HIV+/HIV- subjects.

Reporting Groups
  Description
HIV+/Cervarix Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV+/Aluminium Hydroxide Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV-/Cervarix Group Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.

Participant Flow:   Overall Study
    HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group
STARTED   61   59   30 
COMPLETED   54   52   24 
NOT COMPLETED   7   7   6 
Lost to Follow-up                6                4                5 
Withdrawal by Subject                1                3                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
HIV+/Cervarix Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV+/Aluminium Hydroxide Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV-/Cervarix Group Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Total Total of all reporting groups

Baseline Measures
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   59   30   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.6  (2.21)   22.7  (1.70)   21.3  (1.65)   21.9  (1.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      61 100.0%      59 100.0%      30 100.0%      150 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
African heritage/African American   61   59   30   150 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms   [ Time Frame: Within 7 days (Days 0-6) after each dose and across doses ]

2.  Primary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms   [ Time Frame: Within 7 days (Days 0-6) after each dose and across doses ]

3.  Primary:   Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms   [ Time Frame: Within 30 days (Days 0-29) after vaccination ]
  Hide Outcome Measure 3

Measure Type Primary
Measure Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms
Measure Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Within 30 days (Days 0-29) after vaccination  

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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV+/Aluminium Hydroxide Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV-/Cervarix Group Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms 
[Units: Participants]
Count of Participants
     
Any unsolicited AE(s)   53   46   26 
Grade 3 unsolicited AE(s)   1   1   0 
Related unsolicited AE(s)   16   3   7 

No statistical analysis provided for Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms



4.  Primary:   Number of Subjects With Medically Significant Conditions (MSCs)   [ Time Frame: From Day 0 up to Month 7 ]

5.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 up to Month 7 ]

6.  Primary:   Number of Subjects With Medically Significant Conditions   [ Time Frame: From Day 0 up to Month 12 ]

7.  Primary:   Number of Subjects Reporting Serious Adverse Events   [ Time Frame: From Day 0 up to Month 12 ]

8.  Primary:   Number of Subjects With Pregnancies and Their Outcome   [ Time Frame: From Day 0 up to Month 12 ]

9.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

10.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

11.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

12.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

13.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

14.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

15.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 10 and Month 12 ]

16.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 10 and Month 12 ]

17.  Primary:   Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.   [ Time Frame: At Months 1, 2, 4, 6 and 7 ]

18.  Primary:   Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.   [ Time Frame: At Month 10 and Month 12 ]

19.  Primary:   Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects   [ Time Frame: At pre-vaccination and at Months 1, 2, 4, 6 and 7 ]

20.  Primary:   Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects   [ Time Frame: At Month 10 and Month 12 ]

21.  Primary:   HIV Viral Load at Each Time Point in All HIV+ Subjects   [ Time Frame: At pre-vaccination and at Months 1, 2, 4, 6 and 7 ]

22.  Primary:   HIV Viral Load at Each Time Point in All HIV+ Subjects   [ Time Frame: At Month 10 and Month 12 ]

23.  Primary:   Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Months 2 and 7 ]

24.  Primary:   Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies   [ Time Frame: At Month 12 ]

25.  Primary:   Concentrations for HPV-16 and HPV-18 Antibodies   [ Time Frame: At Months 0, 2 and 7 ]

26.  Primary:   Concentrations for HPV-16 and HPV-18 Antibodies   [ Time Frame: At Month 12 ]

27.  Primary:   Cell Mediated Immune Response (CMI) (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS)   [ Time Frame: At Months 0, 2, 7 and 12 ]

28.  Primary:   Cell Mediated Immune Response (CMI) (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 0 ]

29.  Primary:   CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 2 ]

30.  Primary:   CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 7 ]

31.  Primary:   CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information