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Trial record 2 of 91 for:    cervarix

Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®) (HPVXneutra001)

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ClinicalTrials.gov Identifier: NCT01914367
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 2, 2013
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

Six identical female twins aged 9-13 years will participate. One sib of each twin pair will be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood samples will be taken (the first prior to vaccine administration, the second and third 7 days after dose 2 and 3, respectively). The blood samples will be used to determine: 1) the magnitude the anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the cross-reactive pattern of these responses towards related, non-vaccine HPV strains (HPV-31 and -33, and HPV-45). 3) plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and eventually after the 2nd dose also) will be examined for for the usage of VDJ and VJ segments in the immunoglobulin heavy (VH) and light (VL) heavy and light chains. Gene useg in B cells induced by Cervarix and Gardasil will be compared. Finally the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light (VL) chains from single ASC isolated after the 3rd dose of a three-dose schedule of either Cervarix or Gardasil will be examined.

The duration of the study is approximately 187 days. Five study visits will take place, over a time period of 6.5 months, followed by a telephone call after 12 months.

The purpose of the study is to learn more about the molecular mechanisms underlying the cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).


Condition or disease Intervention/treatment Phase
Infection With Human Papillomavirus Biological: cervarix Biological: Gardasil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)
Study Start Date : September 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: Cervarix group
One sib of each twin pair will be given Cervarix according to the 0, 1, 6 month vaccination scheme.
Biological: cervarix
3 doses will be given, one on Day 0, one on Day 30 and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm
Other Name: GSK's commercially available bivalent HPV types 16 and 18 recombinant vaccine containing AS04 adjuvant (Cervarix®)

Active Comparator: Gardasil Group
One sib of each twin pair will be given Gardasil according to the 0, 1, 6 month vaccination scheme.
Biological: Gardasil
3 doses will be given, one on Day 0, one on Day 60 ± 2 days and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm
Other Name: Merck's commercially availably quadrivalent HPV(types 6, 11, 16, 18) recombinant vaccine containing amorphous aluminiumhydroxyphosphate sulphate adjuvant




Primary Outcome Measures :
  1. comparing of VDJ and VJ segments in the immunoglobulin heavy and light chains/plasmablasts [ Time Frame: at day 187 ]
  2. comparing the mutational diversity that occurs following vaccine-induced affinity maturation in plasmablasts [ Time Frame: at day 187 ]

Secondary Outcome Measures :
  1. evaluation of the cross-reactive pattern of polyclonal serum antibodies [ Time Frame: at day 187 ]
  2. comparing of VDJ and VJ segment usage and affinity maturation in HPV-specific antibodies [ Time Frame: at day 187 ]
  3. comparing of the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light (VL) chains from single ASC [ Time Frame: at day 187 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Six homozygous twins in good health, without preceding sexual activity (virgin). Subjects have a negative pregnancy test on the day of vaccination and have agreed to continue abstinence during the entire study period and for two months after completion of the vaccination series.

Exclusion Criteria:

  • Subjects are not participating in any other clinical trials and have not been vaccinated previously against HPV and have not had an administration of MPL or AS04 in the past.

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): NCT01914367


Contacts
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Contact: Geert Leroux-Roels, MD, PhD +32 9 332 34 22 geert.lerouxroels@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Geert Leroux-Roels, MD, PhD    +32 9 332 34 22    geert.lerouxroels@ugent.be   
Principal Investigator: Geert Leroux-Roels, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Geert Leroux-Roels, MD, PhD University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01914367     History of Changes
Other Study ID Numbers: 2013/422
2013-002340-90 ( EudraCT Number )
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs