Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Human papillomavirus (HPV) Vaccine

Placebo

Long Xu, Ph.D.

Amber Leah, Dr.

This is a Phase I, first-in-human, randomized, observer-blinded, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and immunogenicity of BV601 (a HPV Vaccine) in healthy adult volunteers.

Phase I Clinical Trial of a Candidate HPV Vaccine

A Phase I, First-in-human, Randomized, Observer-blinded, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV601 in Healthy Adult Volunteers

Occurrence of solicited AEs of each subject

Occurrence of solicited systemic AEs of each subject

Percentage of participants with dose-limiting toxicity

Percentage of participants with unsolicited AEs

Frequency and severity of solicited and unsolicited AEs

GMT of anti-L2 immunoglobulin G (IgG) antibody responses

GMT of anti-HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and 73 type specific serum neutralizing antibody (NAb) response

Seroconversion rate of anti-L2 IgG antibody and anti-HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and 73 type-specific serum Nab

Shanghai BravoBio Co., Ltd.

Novotech (Australia) Pty Limited

Wuhan BravoVax Co., Ltd.

Neoplasms

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

5-minute video and information sheet with a list of suggested questions to ask the provider

Educational materials

Maureen Sanderson, PhD

The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.

In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.

An HPV Vaccine Provider Intervention in Safety Net Clinics

Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention

Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.

Cervical cancer screening is no longer recommended annually so the investigators measured receipt of a Pap smear as needed within a 12 month period.

Vanderbilt University

Matthew Walker Comprehensive Health Center

Memphis Health Center

Southside/Dodson Avenue Community Health Centers

Meharry Medical College

Immune System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Syndrome

Blood-Borne Infections

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Slow Virus Diseases

Gastrointestinal Agents

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Clinical Trial of a Candidate HPV Vaccine	NCT05672966	Human Papilloma...	Human papilloma... Placebo	18 Years - 35 Years	Wuhan BravoVax Co., Ltd.
An HPV Vaccine Provider Intervention in Safety Net Clinics	NCT02808832	Human Papilloma... Uterine Cervica...	Educational mat...	9 Years -	Meharry Medical College
Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females	NCT00586339	Infections, Pap...	Cervarix Placebo Control	18 Years - 25 Years	GlaxoSmithKline
Phase I Clinical Trial of a Candidate HPV Vaccine	NCT05672966	Human Papilloma...	Human papilloma... Placebo	18 Years - 35 Years	Wuhan BravoVax Co., Ltd.
Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs	NCT00541970	Infections, Pap...	Cervarix Placebo	9 Years - 25 Years	GlaxoSmithKline
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age	NCT00552279	Infections, Pap...	Cervarix TM Cervarix TM	15 Years - 25 Years	GlaxoSmithKline
Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs	NCT00541970	Infections, Pap...	Cervarix Placebo	9 Years - 25 Years	GlaxoSmithKline

Spots Global Cancer Trial Database for human papillomavirus (hpv) vaccine