Measuring Responses to Sublingual Antigens

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00949572
• Date of registration: 29/07/2009
• Prospective Registration: Yes
• Primary sponsor: St George's, University of London
• Public title: Measuring Responses to Sublingual Antigens
• Scientific title: Characterisation of Human Disseminated Cellular and Humoral Immune Responses Following Sublingual or Intramuscular Deposition of Antigens
• Date of first enrolment: September 2009
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00949572
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: David JM Lewis, MD
• Affiliation: St George's, University of London

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Sexually Transmitted Diseases, Viral

Intervention(s)

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

Primary Outcome(s)

Concentration and isotype profile of antigen-specific antibody in cervico-vaginal secretions measured by ELISA and/or LUMINEX assay [Time Frame: 0, 1, 4 and 5 months after first immunization]

Secondary Outcome(s)

Profile of cytokine secretion by peripheral blood mononuclear cells in response to in vitro antigen stimulation measured by ELISA [Time Frame: 0 and 4 weeks after each immunization]

Concentration and isotype profile of antigen-specific antibody in serum measured by ELISA and/or LUMINEX assay [Time Frame: 0, 1, 4 & 5 months after first immunization]

Frequency and isotype profile of antigen-specific antibody secreting cells in blood [Time Frame: 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 [Time Frame: 0 and 4 weeks after each immunization]

Secondary ID(s)

SG09-EN01

REC number: 09/80803/77

EC grant number 201038

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Union