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

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

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

1.  Primary:

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

2.  Primary:

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

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. ]

4.  Primary:

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

5.  Primary:

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

6.  Primary:

Number of Subjects With Medically Significant Conditions.   [ Time Frame: Up to Month 7. ]

7.  Primary:

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

8.  Primary:

Number of Subjects With Medically Significant Conditions.   [ Time Frame: Up to Month 12. ]

9.  Primary:

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

10.  Primary:

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

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 ]

12.  Primary:

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

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. ]

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. ]

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. ]

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 ]

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. ]

18.  Primary:

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

19.  Primary:

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

20.  Primary:

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

21.  Primary:

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

22.  Primary:

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

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. ]

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 ]

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 ]

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 ]

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 ]

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 ]

29.  Primary:

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