NCT00949572

Brief Summary

This study is a preliminary investigation of immune responses, in the blood and in cervical \& vaginal secretions, to proteins ("antigens") taken up across the undersurface of the tongue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2010

Enrollment Period

9 months

First QC Date

July 29, 2009

Last Update Submit

January 26, 2011

Conditions

Sexually Transmitted Diseases, Viral

Keywords

mucosal immunityimmunizationsublingual

Outcome Measures

Primary Outcomes (1)

  • Concentration and isotype profile of antigen-specific antibody in cervico-vaginal secretions measured by ELISA and/or LUMINEX assay

    0, 1, 4 and 5 months after first immunization

Secondary Outcomes (4)

  • Concentration and isotype profile of antigen-specific antibody in serum measured by ELISA and/or LUMINEX assay

    0, 1, 4 & 5 months after first immunization

  • Frequency and isotype profile of antigen-specific antibody secreting cells in blood

    0 and 1 week after each immunization

  • Frequency and expression profile of mucosa-associated homing, memory and regulatory markers on antigen-specific T cells in blood in response to in vitro antigen stimulation

    0 and 4 weeks after each immunization

  • Profile of cytokine secretion by peripheral blood mononuclear cells in response to in vitro antigen stimulation measured by ELISA

    0 and 4 weeks after each immunization

Study Arms (2)

Intramuscular administration

EXPERIMENTAL

Intramuscular injection of HPV vaccine proteins

Biological: Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads

Sublingual administration

EXPERIMENTAL

Sublingual administration of HPV vaccine proteins

Biological: Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads

Interventions

Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum adsBIOLOGICAL

1 intramuscular dose (0.5 ml) on month 0, 1 and 4 containing approximately: Human Papillomavirus Type 6 L1 protein 20 micrograms Human Papillomavirus Type 11 L1 protein 40 micrograms Human Papillomavirus Type 16 L1 protein 40 micrograms Human Papillomavirus Type 18 L1 protein 20 micrograms

Also known as: Gardasil
Intramuscular administration

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A female adult volunteer aged between 18 and 35 years old.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Provide written informed consent following a detailed written explanation of participation in the protocol.
  • They are in good health as determined by medical history, physical examination, haematology testing, and clinical judgement before entering into the study.
  • They are available for the whole duration of the study.
  • If of childbearing potential, must have a negative pregnancy test before each immunisation.
  • They have not donated blood during 3 months prior to study entry and agree to not donate for 3 months after the end of their participation in the study.
  • They are eligible for free medical treatment

You may not qualify if:

  • They have already been vaccinated with an HPV vaccine
  • They have participated in a clinical trial in the last 6 months in which they have been exposed to an investigational product (pharmaceutical product or placebo or device) or concurrent participation in another clinical research study at the time of enrolment.
  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of challenge agent, or planned use during the study period.
  • They are pregnant or breast-feeding.
  • They have a known or suspected ongoing cervico-vaginal disease, malignancy or abnormality discovered at time of screening.
  • They present in the samples obtained at the screening visit: positive results for HIV, HBs Ag, anti-HBc and anti-HCV antibody, a clinically significant abnormality in haematology. Normal ranges will be defined by the pathology laboratory undertaking assays.
  • They have a clinically significant acute or chronic pulmonary, cardiovascular, hepatic or renal functional abnormality, blood or neurological disorders, immune dysfunction, autoimmune diseases, diabetes (excluding history of gestational diabetes), or malignancy at the time of enrolment, as determined by medical history, physical examination or laboratory screening tests.
  • They have received any form of immunosuppressive therapy in the past 6 months.
  • They are receiving any medications via vaginal route (as this may interfere with collection of samples).
  • They have any tongue or frenulum piercings or oral jewellery that may interfere with sublingual delivery.
  • They have received blood products or immunoglobulins 120 days prior to enrolment.
  • They have thrombocytopaenia or any coagulation disorder (because bleeding may occur following an intramuscular administration in these individuals).
  • Any other medical, psychiatric or social condition, drug treatment, occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contradiction to adherence to the study protocol or ability to give informed consent.
  • Individuals who cannot read or speak fluent English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's Vaccine Institute, St George's University of London

London, England, SW17 0RE, United Kingdom

Location

Related Publications (1)

  • Huo Z, Bissett SL, Giemza R, Beddows S, Oeser C, Lewis DJ. Systemic and mucosal immune responses to sublingual or intramuscular human papilloma virus antigens in healthy female volunteers. PLoS One. 2012;7(3):e33736. doi: 10.1371/journal.pone.0033736. Epub 2012 Mar 16.

    PMID: 22438987DERIVED

Related Links

MeSH Terms

Conditions

Sexually Transmitted Diseases, Viral

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted DiseasesCommunicable DiseasesInfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Officials

  • David JM Lewis, MD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

January 1, 2011

Last Updated

January 27, 2011

Record last verified: 2010-01

Locations

GB(1)