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

NCT ID: NCT00586339

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-17
• Study Completion Date: 2011-07-18

Brief Summary

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.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

HIV+/Cervarix Group

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.

Group Type: EXPERIMENTAL

Cervarix

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

HIV+/Aluminium Hydroxide Group

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.

Group Type: ACTIVE_COMPARATOR

Placebo Control

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

HIV-/Cervarix Group

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.

Group Type: EXPERIMENTAL

Cervarix

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

Cervarix

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Placebo Control

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol
• A female between, and including, 18 and 25 years of age at the time of the first vaccination.
• Written, signed or thumb-printed informed consent obtained from the subject prior to enrolment.
• Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV status.
• Subjects willing to provide place of residence and be visited at home.
• HIV seropositive subjects:

1. Subjects must be HIV seropositive according to WHO case definition

2. Subjects with WHO Clinical Stage 1 HIV-associated disease

3. Subjects currently on antiretroviral therapy (ART) must be compliant to ART and have undetectable viral load

• HIV seronegative subjects: Subjects confirmed as HIV seronegative at the screening visit are eligible to participate in the HIV-/HPV group of the study.
• Non-virgin subjects must have a normal colposcopy at the screening visit.
• Non-virgin subjects must have a normal cervical cytology (Pap smear) or no greater than atypical squamous cells of undetermined significance (ASC-US) at the screening visit.
• All subjects must have a negative urine pregnancy test at the screening visit and at visit 1 (Day 0).
• Subjects must be of non-childbearing potential or, if of childbearing potential, must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
• Subjects must have had no more than 6 life-time sexual partners prior to enrolment.
• Subjects must have one single intact cervix

Exclusion Criteria

• Active tuberculosis (TB)
• Current TB prophylaxis or therapy.
• Anemia at the screening visit.
• increased creatinine at the screening visit.
• Increased hepatic enzym (ALT) at the screening visit
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine/control, or planned use during the entire study period (up to Month 12).
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
• Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine/control. Enrolment will be postponed until the subject is outside the specified window.
• Planned administration of a vaccine not foreseen by the study protocol within 30 days before or 30 days after (i.e., Days 0-29) any dose of study vaccine.
• Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Month 0 to Month 12).
• previous administration of components of the investigational vaccine
• Cancer or autoimmune disease under treatment.
• Hypersensitivity to latex.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
• History of any neurological disorders or seizures.
• Pregnant or breastfeeding female.
• A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
• Concurrently participating in another clinical study, at any time during the study period (up to Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine/control or planned administration during the study period. Enrolment will be postponed until the subject is outside the specified window.
• Administration of trimethoprim/sulphamethoxazole within 7 days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within 7 days after the first dose of study vaccine/control.
• Current drugs or alcohol abuse.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Khayelitsha, , South Africa

Countries

South Africa

References

Denny L, Hendricks B, Gordon C, Thomas F, Hezareh M, Dobbelaere K, Durand C, Herve C, Descamps D. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-positive women in South Africa: a partially-blind randomised placebo-controlled study. Vaccine. 2013 Nov 19;31(48):5745-53. doi: 10.1016/j.vaccine.2013.09.032. Epub 2013 Oct 1.

Reference Type: BACKGROUND

PMID: 24091311 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

107863

Identifier Type: -

Identifier Source: org_study_id