Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00586339
First received: December 21, 2007
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
Results First Received: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: HPV-16/18 Infections
Cervical Neoplasia
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

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  
Number of Participants  
[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  
Gender  
[units: Subjects]
 		       
Female     61     59     30     150  
Male     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting Any Solicited Local Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination. ]
  Show Outcome Measure 1

2.  Primary:   Number of Subjects Reporting Severe (Grade 3) Solicited Local Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination. ]
  Show Outcome Measure 2

3.  Primary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination. ]
  Show Outcome Measure 3

4.  Primary:   Number of Subjects Reporting Any and Related Unsolicited Symptoms.   [ Time Frame: Within 30 days (Days 0-29) after vaccination. ]
  Show Outcome Measure 4

5.  Primary:   Number of Subjects Reporting Severe (Grade 3) Unsolicited Symptoms.   [ Time Frame: Within 30 days (Days 0-29) after vaccination. ]
  Show Outcome Measure 5

6.  Primary:   Number of Subjects With Medically Significant Conditions.   [ Time Frame: Up to Month 7. ]
  Show Outcome Measure 6

7.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: Up to Month 7. ]
  Show Outcome Measure 7

8.  Primary:   Number of Subjects With Medically Significant Conditions.   [ Time Frame: Up to Month 12. ]
  Show Outcome Measure 8

9.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: Up to Month 12. ]
  Show Outcome Measure 9

10.  Primary:   Number of Subjects With Pregnancies and Their Outcome.   [ Time Frame: Up to Month 12. ]
  Show Outcome Measure 10

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

12.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At month 10 and month12. ]
  Show Outcome Measure 12

13.  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. ]
  Show Outcome Measure 13

14.  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. ]
  Show Outcome Measure 14

15.  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. ]
  Show Outcome Measure 15

16.  Primary:   Number of CD4+ Cells Per Cubic Millimetre at Each Time Point in All HIV+ Subjects.   [ Time Frame: At Month 10 and Month 12 ]
  Show Outcome Measure 16

17.  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. ]
  Show Outcome Measure 17

18.  Primary:   HIV Viral Load at Each Time Point in All HIV+ Subjects.   [ Time Frame: At Month 10 and Month 12 ]
  Show Outcome Measure 18

19.  Primary:   Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Months 2 and 7 ]
  Show Outcome Measure 19

20.  Primary:   Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Month 12 ]
  Show Outcome Measure 20

21.  Primary:   Concentrations for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Months 0, 2 and 7. ]
  Show Outcome Measure 21

22.  Primary:   Concentrations for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Month 12. ]
  Show Outcome Measure 22

23.  Primary:   Cell Mediated Immune Response (CMI) (B-cell and 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. ]
  Show Outcome Measure 23

24.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, at Months 1, 2, 4, 6 and 7 ]
  Show Outcome Measure 24

25.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, at Months 1, 2, 4, 6 and 7 ]
  Show Outcome Measure 25

26.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, at Months 1, 2, 4, 6 and 7 ]
  Show Outcome Measure 26

27.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, at Months 1, 2, 4, 6 and 7 ]
  Show Outcome Measure 27

28.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, at Months 1, 2, 4, 6 and 7 ]
  Show Outcome Measure 28

29.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 10 and Month 12 ]
  Show Outcome Measure 29


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Serious adverse events were assessed up to Month 12. Systematically and non-systematically assessed frequent adverse events were assessed within the 7 day (Days 0-6) and 30 day (Days 0-29) post-vaccination period respectively.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    HIV+/Cervarix Group     HIV+/Aluminium Hydroxide Group     HIV-/Cervarix Group  
Total, other (not including serious) adverse events        
# participants affected / at risk     52/61     27/59     28/30  
Gastrointestinal disorders        
Diarrhoea *      
# participants affected / at risk     4/61 (6.56%)     6/59 (10.17%)     1/30 (3.33%)  
Dyspepsia *      
# participants affected / at risk     1/61 (1.64%)     1/59 (1.69%)     2/30 (6.67%)  
General disorders        
Injection site erythema *      
# participants affected / at risk     7/61 (11.48%)     1/59 (1.69%)     4/30 (13.33%)  
Injection site induration *      
# participants affected / at risk     4/61 (6.56%)     0/59 (0.00%)     4/30 (13.33%)  
Injection site pruritus *      
# participants affected / at risk     3/61 (4.92%)     0/59 (0.00%)     2/30 (6.67%)  
Pain †      
# participants affected / at risk     52/61 (85.25%)     27/59 (45.76%)     28/30 (93.33%)  
Swelling †      
# participants affected / at risk     19/61 (31.15%)     2/59 (3.39%)     12/30 (40.00%)  
Arthralgia †      
# participants affected / at risk     4/61 (6.56%)     4/59 (6.78%)     2/30 (6.67%)  
Fatigue †      
# participants affected / at risk     18/61 (29.51%)     16/59 (27.12%)     8/30 (26.67%)  
Fever †      
# participants affected / at risk     2/61 (3.28%)     3/59 (5.08%)     2/30 (6.67%)  
Gastrointestinal †      
# participants affected / at risk     15/61 (24.59%)     11/59 (18.64%)     13/30 (43.33%)  
Headache †      
# participants affected / at risk     23/61 (37.70%)     26/59 (44.07%)     16/30 (53.33%)  
Myalgia †      
# participants affected / at risk     3/61 (4.92%)     3/59 (5.08%)     7/30 (23.33%)  
Infections and infestations        
Upper respiratory tract infection *      
# participants affected / at risk     10/61 (16.39%)     10/59 (16.95%)     7/30 (23.33%)  
Nasopharyngitis *      
# participants affected / at risk     3/61 (4.92%)     6/59 (10.17%)     3/30 (10.00%)  
Vulvovaginal candidiasis *      
# participants affected / at risk     5/61 (8.20%)     4/59 (6.78%)     0/30 (0.00%)  
Urinary tract infection *      
# participants affected / at risk     1/61 (1.64%)     2/59 (3.39%)     2/30 (6.67%)  
Musculoskeletal and connective tissue disorders        
Back pain *      
# participants affected / at risk     5/61 (8.20%)     4/59 (6.78%)     3/30 (10.00%)  
Nervous system disorders        
Headache *      
# participants affected / at risk     12/61 (19.67%)     14/59 (23.73%)     4/30 (13.33%)  
Dizziness *      
# participants affected / at risk     4/61 (6.56%)     4/59 (6.78%)     2/30 (6.67%)  
Respiratory, thoracic and mediastinal disorders        
Cough *      
# participants affected / at risk     8/61 (13.11%)     5/59 (8.47%)     4/30 (13.33%)  
Epistaxis *      
# participants affected / at risk     0/61 (0.00%)     3/59 (5.08%)     1/30 (3.33%)  
Skin and subcutaneous tissue disorders        
Rash *      
# participants affected / at risk     2/61 (3.28%)     0/59 (0.00%)     2/30 (6.67%)  
† Events were collected by systematic assessment
* Events were collected by non-systematic assessment



  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00586339     History of Changes
Other Study ID Numbers: 107863
Study First Received: December 21, 2007
Results First Received: February 16, 2012
Last Updated: July 19, 2012
Health Authority: South Africa: Medicines Control Council