Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Long Term Immunity Following HPV Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276521
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : September 23, 2015
Sponsor:
Collaborators:
Department of Foregin Affairs and Trade, Australia
Ministry of Health, Fiji
The Royal Women Hospital
Colonial War Memorial Hospital
Information provided by (Responsible Party):
Murdoch Childrens Research Institute

Brief Summary:
In Fiji, cervical cancer is the second most frequent cancer and the highest cause of cancer mortality in women. In 2008/9, the Ministry of Health in Fiji accepted a donation of 110,000 doses of quadrivalent HPV vaccine, Gardasil® based on the high cervical cancer disease burden. There was enough vaccine to vaccinate all girls aged 9-12 years (30,338 girls) with a three-dose schedule, but not all girls received three doses of the vaccine. This means those girls that received reduced doses may not be fully protected against the HPV genotypes present in the Gardasil®. While HPV vaccines are highly immunogenic and efficacious in the licensed three-dose schedule, there is limited information about the effectiveness of reduced dose schedules in terms of immunogenicity and memory. There is growing evidence from other studies that two doses of HPV vaccine may be sufficient for protection. Reduced schedules would be of benefit in Fiji due to improved costs and logistics. This study will examine whether one or two doses of HPV vaccine provide similar immunological evidence of long-term protection to the standard three-dose schedule in terms of antibody titres to the genotypes present in the Gardasil®. To compare immunological memory responses between dosage groups, a dose of Cervarix ® will be administered to all girls so that the magnitude of the memory responses can be measured.

Condition or disease Intervention/treatment
Cervical Cancer Anogenital Warts Biological: Cervarix®

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Long-term Immunological Responses Following Reduced Dose Quadrivalent Human Papillomavirus (HPV) Vaccine Schedules: A Phase II/III Clinical Trial
Study Start Date : February 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Group/Cohort Intervention/treatment
Zero dose group
Participants that did not received any HPV vaccine previously.
Biological: Cervarix®
All groups will received one dose of Cervarix® vaccine

One dose group
Participants that received one dose of Gardasil® vaccine 5-6 years ago from a vaccination campaign.
Biological: Cervarix®
All groups will received one dose of Cervarix® vaccine

Two dose group
Participants that received two dose of Gardasil® vaccine 5-6 years ago from a vaccination campaign.
Biological: Cervarix®
All groups will received one dose of Cervarix® vaccine

Three dose group
Participants that received three dose of Gardasil® vaccine 5-6 years ago from a vaccination campaign.
Biological: Cervarix®
All groups will received one dose of Cervarix® vaccine




Primary Outcome Measures :
  1. GMCs of HPV- specific antibody titres against HPV 6, 11, 16 and 18 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. GMCs of HPV- specific antibody titres against HPV 6, 11, 16 and 18 one month post Cervarix® [ Time Frame: 6 months ]
  2. Number of HPV- specific memory B- and T- cells against HPV 6, 11, 16 and 18 pre and one month post Cervarix® [ Time Frame: 11 months ]
  3. Fold change in the gene expression profiles in immune cells both pre- and one month post Cervarix® [ Time Frame: 11 months ]

Biospecimen Retention:   Samples With DNA
We will be collecting blood from the participants, which include the plasma and peripheral blood mononuclear cells.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In 2008/9, the MoH in Fiji accepted a one-off donation of 110,000 doses of Gardasil® vaccine, which was enough to vaccinate four birth cohorts of girls (30,338 girls aged 9-12 years) with a three-dose schedule via a school-based program. However, not all the girls received the full-recommended three-dose schedule, mainly due to absence from school on the day the school health team were visiting. The coverage following the initial and the subsequent mop-up campaign was: 62%, 56%, and 55% for doses one, two, and three respectively. The girls that received different doses of Gardasil® vaccine in Suva area who are potentially contactable in this study are 676 (three doses), 204 (two doses) and 116 (one dose), demonstrating feasibility of recruitment.
Criteria

Inclusion Criteria:

  • Girls who live in Suva and were previously vaccinated with one, two or three Gardasil® doses or were eligible but did not receive Gardasil® vaccine in the 2008/9 campaign will be eligible for the study.

Exclusion Criteria:

  • Any participant who had anaphylaxis following a previous dose of the vaccine, anaphylaxis to any vaccine component, or possible pregnancy will be excluded from this study.
  • In addition, any participant whose dates of previous Gardasil® vaccination are uncertain, or has received Cervarix® vaccine previously, or has an axillary temperature greater than 38°C will be excluded from this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276521


Locations
Layout table for location information
Fiji
Colonial War Memorial Hospital
Suva, Fiji
Sponsors and Collaborators
Murdoch Childrens Research Institute
Department of Foregin Affairs and Trade, Australia
Ministry of Health, Fiji
The Royal Women Hospital
Colonial War Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Edward K Mulholland Murdoch Childrens Research Institute

Publications:
de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, Vallejos CS, de Ruiz PA, Lima MA, Guimera N, Clavero O, Alejo M, Llombart-Bosch A, Cheng-Yang C, Tatti SA, Kasamatsu E, Iljazovic E, Odida M, Prado R, Seoud M, Grce M, Usubutun A, Jain A, Suarez GA, Lombardi LE, Banjo A, Menéndez C, Domingo EJ, Velasco J, Nessa A, Chichareon SC, Qiao YL, Lerma E, Garland SM, Sasagawa T, Ferrera A, Hammouda D, Mariani L, Pelayo A, Steiner I, Oliva E, Meijer CJ, Al-Jassar WF, Cruz E, Wright TC, Puras A, Llave CL, Tzardi M, Agorastos T, Garcia-Barriola V, Clavel C, Ordi J, Andújar M, Castellsagué X, Sánchez GI, Nowakowski AM, Bornstein J, Muñoz N, Bosch FX; Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-56. doi: 10.1016/S1470-2045(10)70230-8. Epub 2010 Oct 15.

Layout table for additonal information
Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT02276521     History of Changes
Other Study ID Numbers: 2014.5.FNRERC.5.SU
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Diseases
Vaccines
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs