Advertisement
Advertise here Publish your press releases here Sponsor BioPortfolio
Follow us on Twitter Sign up for daily news and research emails Contributors wanted

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

23:45 EDT 23rd April 2014 | BioPortfolio

Summary

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).

The protocol posting has been updated following Protocol update in April 2010. The section impacted is eligibility criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Human Papillomavirus Infection

Intervention

Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, GSK Biologicals' HPV vaccine 580299

Location

GSK Investigational Site
Khon Kaen
Thailand
40002

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.

A live attenuated virus vaccine of duck embryo or human diploid cell tissue culture origin, used for routine immunization of children and for immunization of nonpregnant adolescent and adult females of childbearing age who are unimmunized and do not have serum antibodies to rubella. Children are usually immunized with measles-mumps-rubella combination vaccine. (Dorland, 28th ed)

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.

Clinical Trials [2251 Associated Clinical Trials listed on BioPortfolio]

Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

The primary study hypothesis is that a two-dose human papillomavirus (HPV) vaccine regimen would offer similar immunogenicity and protection as that of a three-dose regimen to girls agains...

Immunogenicity of GSK Bio's HPV Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age

HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine which targets the 2 most common oncogenic HPV typ...

An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects

To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.

Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells. PURPOSE: This phase II trial is studying the side effects and ho...

Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents

Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined dipht...

PubMed Articles [11777 Associated PubMed Articles listed on BioPortfolio]

Effectiveness of the Quadrivalent Human Papillomavirus Vaccine Against Cervical Dysplasia in Manitoba, Canada.

Effectiveness of the quadrivalent human papillomavirus (QHPV) vaccine against cervical dysplasia has not been estimated using population-based individual level data. We assessed the vaccine effectiven...

HPV Vaccine Works against Nine Viral Types.

In a phase III study, Merck's V503 human papillomavirus (HPV) vaccine prevented 97% of high-grade, precancerous vaginal, vulvar, and cervical disease caused by HPV types 31, 33, 45, 52, and 58. The ne...

Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Women.

Background. HIV-infected women are disproportionately affected by human papillomavirus (HPV)-related anogenital disease, particularly with increased immunosuppression. A5240 was a trial of 319 HIV-i...

Prevaccine era human papillomavirus types 6, 11, 16 and 18 seropositivity in the USA, National Health and Nutrition Examination Surveys, 2003-2006.

A vaccine is available to prevent human papillomavirus (HPV) 6, 11, 16 and 18; in the prevaccine era, seropositivity to vaccine types is a measure of natural exposure.

Physicians' human papillomavirus vaccine recommendations, 2009 and 2011.

Physician recommendation is a key predictor of human papillomavirus (HPV) vaccine uptake. Understanding factors associated with recommendation is important for efforts to increase current suboptimal v...

More From BioPortfolio on "Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females"

Search BioPortfolio:
Advertisement
Advertisement

Searches Linking to this Trial