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1 Clinical Trial Details (PDF Generation Date :- Wed, 27 Mar :50:17 GMT) CTRI Number CTRI/2009/091/ [Registered on: 15/10/2010] - Last Modified On 11/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Vaccine Biological Preventive Randomized, Parallel Group, Multiple Arm Trial Evaluation of safety and immunogenicity of a Human Papillomavirus (HPV) vaccine in human immunodeficiency virus (HIV) infected females A phase IV, observer-blind, randomized, controlled, multicentric study to assess the safety and immunogenicity of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine (CervarixTM) administered intramuscularly according to a three-dose schedule (Day 0, Week 6, Month 6) in human immunodeficiency virus-infected (HIV+) female subjects aged years, as compared to Mercks HPV-6/11/16/18 vaccine (Gardasil ). Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Amendment 7 Final Protocol (19 December 2013) Protocol Number EudraCT NCT Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Dr Shailesh Mehta Vice President GlaxoSmithKline Phone Fax Designation Affiliation Dr. Annie Besant Road shailesh.i.mehta@gsk.com Details Contact Person (Scientific Query) Dr Shailesh Mehta Vice President GlaxoSmithKline Phone Fax Designation Affiliation Dr. Annie Besant Road shailesh.i.mehta@gsk.com Details Contact Person (Public Query) Dr Shailesh Mehta Vice President GlaxoSmithKline page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Phone Fax > NIL Type of Sponsor NIL List of Countries Brazil Estonia Thailand of Principal Investigator Partha Basu Dattatray Saple Smita Joshi Nagalingeshwaran Kumarasamy Dr. Annie Besant Road Source of Monetary or Material Support Primary Sponsor Details GlaxoSmithKline Biologicals 89, Rue de linstitut 1330, Rixensart, Belgium. Pharmaceutical industry-global of Site Site Phone/Fax/ Chittaranjan National Cancer Institute, Kolkata, Clinical Ethics Forum,, Jehangir Clinical Development Centre, Pune, Y. R. G Care, Chennai, 37, S.P.Mukherjee Road, Kolkata Kolkata WEST BENGAL Hindu Colony 3rd Lane, Near Bhagini Samaj, Dadar East No.88, , 32, Sasson Road, Pune , Pune Tidal Park road, V.H.S Hospital, Chennai Chennai TAMIL NADU basupartha@hotmail.co m clinicaltrial@drsaple.co m smitanjoshi@gmail.com kumarasamy@yrgcare. org of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee - Snehal Hospital, Thane Institutional Ethics Committee, CNCI, Kolkata, Approved 23/02/2014 Yes Approved 17/04/2014 No Institutional Review Approved 22/03/2014 No page 2 / 6

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Board, YRG Care Medical Centre, Chennai, Jehangir Clinical Development Centre, Medical Research Insitute, Pune, Status Approved 18/02/2014 No Date Approved/Obtained 16/12/2014 Health Type Healthy Human Volunteers Condition Infections, Papillomavirus Type Details Intervention Intervention GSK Biologicals HPV vaccine Merck s Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil) Comparator Agent NIL NIL Age From Age To Gender Details Year(s) Year(s) Female Inclusion Criteria Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule Subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol. A female between, and including, 15 and 25 years of age at the time of the first vaccination. Written informed consent obtained from the subject and/or from the subject s parent or LAR. Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV infection status. For HIV seropositive subjects: - Subjects must be HIV seropositive according to World Health Organization (WHO) case definition. - Subject must be asymptomatic (or only have persistent generalized lymphadenopathy). - Subjects should have a CD4 cell count > 350 cells/mm3. - If currently taking antiretrovirals (ARVs), subjects must be on compliant to triple therapy (highly active ART) and have undetectable viral load on two previous clinical visits within the six months prior to study entry. For HIV seronegative subjects: - Subjects confirmed as HIV seronegative at the screening visit. For non-virgin female subjects: - Subjects must have no history of abnormal cytology or CIN 1/2/3. - Subjects must have had no more than six life-time sexual partners prior to enrollment. Subjects must have no history of congenital malformations of the uterine cervix, or history of cauterization or surgical procedures page 3 / 6

4 involving damage to the transformation zone of the cervix or stenosis. Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series. Exclusion Criteria Details Exclusion Criteria Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 24). ART not compliant with the National Guidelines. Active tuberculosis (TB) visit (criteria mandatory only for HIV+ subjects). Current TB therapy. Hemoglobin Creatinine > 1.5-fold the upper limit of normal (ULN) at the screening visit. Alanine aminotransferase (ALT)> 2.5-fold ULN at the screening visit. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period (Day 0 to Month 24). Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs (with the exception of ART) within six months prior to the first vaccine dose. Administration of a vaccine not foreseen by the study protocol within 30 days (Days 0-29) before the first dose of study vaccine/control. Enrollment 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 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 and/or fever at the time of enrollment. 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 (i.e., up to Month 8). Concurrently participating in another clinical study, at any time during the study period (Day 0 to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product. Any medically diagnosed or suspected immunodeficient condition page 4 / 6

5 (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. Enrollment will be postponed until the subject is outside the specified window. Administration of trimethoprim/sulphamethoxazole within seven days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within seven days after the first dose of study vaccine/control. Current drugs or alcohol abuse. Child in care. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Occurrence, intensity and relationship to vaccination of solicited and unsolicited symptoms in HIV+ subjects Occurrence of SAEs, medically significant conditions and clinically relevant abnormalities in hematological and biochemical parameters; CD4 cell count, HIV viral load, and HIV clinical staging; and occurrence and outcome of pregnancies in HIV+ subjects HPV-16 /18 antibody titers by PBNA in HIV+ subjects During the 7-day (Days 0 6) and 30-day (Days 0 29) follow-up period after each vaccination, respectively Throughout the active phase of the study (up to Month 7) At Month 7 Secondary Outcome Outcome Timepoints Occurrence and intensity of solicited local symptoms in HIV- subjects Occurrence, intensity and relationship to vaccination of solicited general symptoms in HIV- subjects Occurrence, intensity and relationship to vaccination of unsolicited symptoms in HIVsubjects Occurrence of SAEs up to 30 days after the last dose of vaccine in HIV- subjects During the 7-day (Days 0 to 6) follow-up period after each and any vaccination During the 7-day (Days 0 to 6) follow-up period after each and any vaccination During the 30-day (Days 0 to 29) follow-up period after any vaccination Throughout the active phase of the study (up to Month 7) Occurrence of medically significant conditions (including pimds) up to 30 days after the last dose of vaccine in HIV- subjects Throughout the active phase of the study (up to Month 7) Occurrence and outcome of pregnancies in all subjects Occurrence of clinically relevant abnormalities in hematological and biochemical parameters in all subjects Throughout the entire study (up to Month 24) At Months 12, 18 and 24 Occurrence of SAEs in all subjects Throughout the entire study (up to Month 24) Occurrence of medically significant conditions Up to 12 months after the last vaccine dose (up page 5 / 6

6 Powered by TCPDF ( Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary (including pimds) in all subjects to Month 18) CD4 cell count, HIV viral load and HIV clinical staging in HIV+ subjects HPV-16 and HPV-18 antibody titers by Pseudovirion-Based Neutralization Assay (PBNA) in HIV- subjects At Months 12, 18 and 24 At Month 7 HPV-16 and HPV-18 antibody titers and total At Day 0, Week 6, Week 10, Months 7, 12, 18 Immunoglobulin G (IgG) titers by Enzyme-Linked and 24 ImmunoSorbent Assay in serum in all subjects HPV-16 and HPV-18 antibody titers and total At Day 0, Week 6, Week 10, Months 7, 12 and Immunoglobulin G (IgG) titers by Enzyme-Linked 24 ImmunoSorbent Assay in cervicovaginal secretion (CVS) in post-menarcheal subjects who volunteer for this procedure Frequencies of HPV-16 and HPV-18 specific B cells and T cells in subset of approximately 100 subjects (50 HIV+ and 50 HIV-) Total Sample Size=708 Sample Size from =300 26/10/ /10/2010 Years=4 Months=3 Days=2 Closed to Recruitment of Participants Closed to Recruitment of Participants None yet At Day 0, Week 6, Week 10, Months 7 and 12 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 CervarixTM 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 CervarixTM or Gardasil ) according to a three-dose schedule (Day 0, Week 6, Month 6). It is planned to enrol 708 subjects in the study of which 300 subjects are planned to be recruited in. The study is planned to start in on 15 Oct page 6 / 6