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Uterine Cervical Neoplasms

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Vaccines

Aluminum Hydroxide

Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.

Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Cervarix

Placebo Control

GSK Clinical Trials

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current study is designed to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV vaccine 580299 in HIV infected adult females living in the Republic of South Africa. The study is double blinded, randomized for HIV positive subjects and open for HIV negative subjects. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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

Evaluation of the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in Adult Human Immunodeficiency Virus (HIV) Infected Female Subjects

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Solicited local symptoms assessed were pain and swelling. Any = occurrence of any solicited local regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Solicited local symptoms were assessed as related to the study vaccination.

Solicited general symptoms assessed were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally 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 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.

MSCs were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Haematological laboratory parameters assessed were red blood cells (RBC) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were white blood cells (WBC) and neutrophils (NEU). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were haemoglobin (Hgb) and haematocrit (Hct). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological and biochemical laboratory parameters assessed were eosinophils (EOS), basophils (BAS) and creatinine (CREA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Biochemical laboratory parameter assessed was alanine aminotransferase (ALAT). By pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological and biochemical laboratory parameters assessed were alanine aminotransferase (ALAT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocrit (Hct), haemoglobin (Hgb), lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The number of CD4+ cells per cubic millimeter (mm\^3) in all HIV+ subjects at pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 is reported.

The number of CD4+ cells per cubic millimeter (mm\^3) in all HIV+ subjects at Month 10 and Month 12 is reported.

The viral load was calculated by estimating the amount of virus in blood samples and it was given in number of Ribonucleic acid copies per milliliter (in log10) \[RNA copies/mL (in log10)\].

The viral load was calculated by estimating the amount of virus in blood samples and was given in number of RNA copies/mL (in log 10).

CD4+ cell count categories, at baseline, assessed were (i) below (\<) 200 CD4+ cells per cubic millimeter (mm\^3), (ii) between 200 and 500 CD4+ cells/mm\^3 and (iii) above 500 CD4+ cells/mm\^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

CD4+ cell count categories, at baseline, assessed were: (i) below (\<) 200 CD4+ cells per cubic millimeter (mm\^3), (ii) between 200 and 500 CD4+ cells/mm\^3 and (iii) above (\>) 500 CD4+ cells/mm\^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 EL.U/mL and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the According-to-Protocol (ATP) cohort for immunogenicity regardless of baseline serostatus.

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.

Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (\>) 0 as measured by Flow cytometry.

The CMI response is the measure of the cytokines production \[i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)\] by HPV-antigen specific T lymphocytes and measured by Intracellular Cytokine Staining (ICS) assay. The results were expressed as a frequency of positive CD4 or CD8 T-cell producing at least 1 cytokine within the CD4 or CD8 T-cell sub-population. All doubles = T cell expressing at least 2 cytokines.

GlaxoSmithKline

HIV+/Cervarix Group

HIV+/Aluminium Hydroxide Group

HIV-/Cervarix Group

Total

Age, Continuous

Sex: Female, Male

African heritage/African American

Race/Ethnicity, Customized

GSK Response Center

Any Pain, Dose 1

Grade 3 Pain, Dose 1

Any Swelling, Dose 1

Grade 3 Swelling, Dose 1

Any Pain, Dose 2

Grade 3 Pain, Dose 2

Any Swelling, Dose 2

Grade 3 Swelling, Dose 2

Any Pain, Dose 3

Grade 3 Pain, Dose 3

Any Swelling, Dose 3

Grade 3 Swelling, Dose 3

Any Pain, Across doses

Grade 3 Pain, 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 who had their symptom sheet filled in and for whom data were available.

Number of Subjects Reporting 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 Fever, Dose 1

Grade 3 Fever, Dose 1

Related Fever, 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 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 Fever, Dose 2

Grade 3 Fever, Dose 2

Related Fever, 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 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 Fever, Dose 3

Grade 3 Fever, Dose 3

Related Fever, 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 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 Fever, Across doses

Grade 3 Fever, Across doses

Related Fever, 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 Urticaria, Across doses

Grade 3 Urticaria, Across doses

Related Urticaria, Across doses

Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms

Any unsolicited AE(s)

Grade 3 unsolicited AE(s)

Related unsolicited AE(s)

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

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms

Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7

Number of Subjects Reporting Serious Adverse Events (SAEs) From Day 0 up to Month 7

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported pregnancies and outcomes of reported pregnancies.

Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 7

Number of Subjects Reporting SAEs From Day 0 up to Month 12

Number of Subjects With MSCs From Day 0 up to Month 12

Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 12

RBC [pre-vacc Normal; post-vacc Normal] Day 7

RBC [pre-vacc Normal; post-vacc Below] Day 7

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7

Spots Global Cancer Trial Database for Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females

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