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�)
Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection With Human Papillomavirus
Intervention: cervarix (Biological); Gardasil (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s): Geert Leroux-Roels, MD, PhD, Principal Investigator, Affiliation: Ghent University Hospital
Overall contact: Geert Leroux-Roels, MD, PhD, Phone: +32 9 332 34 22, Email: geert.lerouxroels@ugent.be
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®).
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: comparing of VDJ and VJ segments in the immunoglobulin heavy and light chains/plasmablastscomparing the mutational diversity that occurs following vaccine-induced affinity maturation in plasmablasts
Secondary outcome: evaluation of the cross-reactive pattern of polyclonal serum antibodiescomparing of VDJ and VJ segment usage and affinity maturation in HPV-specific antibodies 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
Eligibility
Minimum age: 9 Years.
Maximum age: 13 Years.
Gender(s): Female.
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.
Locations and Contacts
Geert Leroux-Roels, MD, PhD, Phone: +32 9 332 34 22, Email: geert.lerouxroels@ugent.be
Ghent University Hospital, Ghent, Oost-Vlaanderen 9000, Belgium; Recruiting Geert Leroux-Roels, MD, PhD, Phone: +32 9 332 34 22, Email: geert.lerouxroels@ugent.be Geert Leroux-Roels, MD, PhD, Principal Investigator
Additional Information
Starting date: September 2013
Last updated: June 2, 2015
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