Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Immune System Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Virus Diseases

Syndrome

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Slow Virus Diseases

Genital Diseases

Urogenital Diseases

All Drugs and Chemicals

Vaccines

Immunologic Factors

HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

GSK Biologicals' HPV vaccine 580299

Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)

GSK Clinical Trials

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix or Gardasil) according to a three-dose schedule (Day 0, Week 6, Month 6).

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females

IPD for this study will be made available via the Clinical Study Data Request site.

Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, rash, temperature \[defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.

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 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.

SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.

Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.

Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.

Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophilis \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\], haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\], monocytes \[MONO\], neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.

HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.

HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \[WHO, 2009\].

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects.

Between-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline).

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects.

Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).

Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophils \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Among assessed haematological parameters were: haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\] and monocytes \[MONO\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Among assessed haematological parameters were: neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], for HIV- subjects.

Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).

Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.

Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.

B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).

The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).

GlaxoSmithKline

HIV+/Cervarix Group

HIV+/Gardasil Group

HIV-/Cervarix Group

HIV-/Gardasil Group

Total

Age, Continuous

Sex: Female, Male

African Heritage/African American

Asian - Central/South Asian Heritage

Asian - East Asian Heritage

Asian - Japanese Heritage

Asian - South East Asian Heritage

White - Arabic/North African Heritage

White - Caucasian/European Heritage

Unspecified

Race/Ethnicity, Customized

GSK Response Center

Any Pain, Dose 1

Grade 3 Pain, Dose 1

Any Redness, Dose 1

Grade 3 Redness, Dose 1

Any Swelling, Dose 1

Grade 3 Swelling, Dose 1

Any Pain, Dose 2

Grade 3 Pain, Dose 2

Any Redness, Dose 2

Grade 3 Redness, Dose 2

Any Swelling, Dose 2

Grade 3 Swelling, Dose 2

Any Pain, Dose 3

Grade 3 Pain, Dose 3

Any Redness, Dose 3

Grade 3 Redness, Dose 3

Any Swelling, Dose 3

Grade 3 Swelling, Dose 3

Any Pain, Across Doses

Grade 3 Pain, Across Doses

Any Redness, Across Doses

Grade 3 Redness, Across Doses

Any Swelling, Across Doses

Grade 3 Swelling, Across Doses

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.

Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms

Any Arthralgia, Dose 1

Grade 3 Arthralgia, Dose 1

Related Arthralgia, Dose 1

Any Fatigue, Dose 1

Grade 3 Fatigue, Dose 1

Related Fatigue, Dose 1

Any Gastrointestinal, Dose 1

Grade 3 Gastrointestinal, Dose 1

Related Gastrointestinal, Dose 1

Any Headache, Dose 1

Grade 3 Headache, Dose 1

Related Headache, Dose 1

Any Myalgia, Dose 1

Grade 3 Myalgia, Dose 1

Related Myalgia, Dose 1

Any Rash, Dose 1

Grade 3 Rash, Dose 1

Related Rash, Dose 1

Any Temperature, Dose 1

Grade 3 Temperature, Dose 1

Related Temperature, Dose 1

Any Urticaria, Dose 1

Grade 3 Urticaria, Dose 1

Related Urticaria, Dose 1

Any Arthralgia, Dose 2

Grade 3 Arthralgia, Dose 2

Related Arthralgia, Dose 2

Any Fatigue, Dose 2

Grade 3 Fatigue, Dose 2

Related Fatigue, Dose 2

Any Gastrointestinal, Dose 2

Grade 3 Gastrointestinal, Dose 2

Related Gastrointestinal, Dose 2

Any Headache, Dose 2

Grade 3 Headache, Dose 2

Related Headache, Dose 2

Any Myalgia, Dose 2

Grade 3 Myalgia, Dose 2

Related Myalgia, Dose 2

Any Rash, Dose 2

Grade 3 Rash, Dose 2

Related Rash, Dose 2

Any Temperature, Dose 2

Grade 3 Temperature, Dose 2

Related Temperature, Dose 2

Any Urticaria, Dose 2

Grade 3 Urticaria, Dose 2

Related Urticaria, Dose 2

Any Arthralgia, Dose 3

Grade 3 Arthralgia, Dose 3

Related Arthralgia, Dose 3

Any Fatigue, Dose 3

Grade 3 Fatigue, Dose 3

Related Fatigue, Dose 3

Any Gastrointestinal, Dose 3

Grade 3 Gastrointestinal, Dose 3

Related Gastrointestinal, Dose 3

Any Headache, Dose 3

Grade 3 Headache, Dose 3

Related Headache, Dose 3

Any Myalgia, Dose 3

Grade 3 Myalgia, Dose 3

Related Myalgia, Dose 3

Any Rash, Dose 3

Grade 3 Rash, Dose 3

Related Rash, Dose 3

Any Temperature, Dose 3

Grade 3 Temperature, Dose 3

Related Temperature, Dose 3

Any Urticaria, Dose 3

Grade 3 Urticaria, Dose 3

Related Urticaria, Dose 3

Any Arthralgia, Across Doses

Grade 3 Arthralgia, Across Doses

Related Arthralgia, Across Doses

Any Fatigue, Across Doses

Grade 3 Fatigue, Across Doses

Related Fatigue, Across Doses

Any Gastrointestinal, Across Doses

Grade 3 Gastrointestinal, Across Doses

Related Gastrointestinal, Across Doses

Any Headache, Across Doses

Grade 3 Headache, Across Doses

Related Headache, Across Doses

Any Myalgia, Across Doses

Grade 3 Myalgia, Across Doses

Related Myalgia, Across Doses

Any Rash, Across Doses

Grade 3 Rash, Across Doses

Related Rash, Across Doses

Any Temperature, Across Doses

Grade 3 Temperature, Across Doses

Related Temperature, Across Doses

Any Urticaria, Across Doses

Grade 3 Urticaria, Across Doses

Related Urticaria, Across Doses

Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms

Any AE(s)

Grade 3 AE(s)

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Spots Global Cancer Trial Database for Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial