AzTrials
AzTrials

Sexually Transmitted Diseases, ViralNCT00949572

Measuring Responses to Sublingual Antigens

A study testing Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads in people with Sexually Transmitted Diseases, Viral, run by St George's, University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sexually Transmitted Diseases, Viral
What is being tested?
Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2009to Jan 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

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

    London, England, SW17 0RE

Other trials in United Kingdom

About this study

Official title: Characterisation of Human Disseminated Cellular and Humoral Immune Responses Following Sublingual or Intramuscular Deposition of Antigens

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.

Read the detailed description

Animal studies have shown that this "sublingual" surface can take up antigens and stimulate immune responses, which may have a different character to responses induced by injecting the same antigens. In previous studies of nasal and oral delivery, we used licensed vaccine preparations as pure and well-characterised model antigens safe for use in humans. We will use a licensed "HPV" vaccine as the source of antigens in this study. The quantity and character of responses (lymphocyte number and pattern of surface proteins, concentration and type of antibodies in fluids) will be measured in detail in various anatomical sites (blood, vaginal secretions) before and after delivery of antigens on three occasions. As well as using established immune assays to characterise the responses, we will develop new research assays to detect populations of lymphocytes and antibodies present in secretions. To ensure we have positive samples to include in our assays and validate new techniques, we will recruit some subjects to receive a standard intramuscular injection, as this is known to be nearly 100% reliable in inducing measurable immune responses. As this is a preliminary study we will recruit enough subjects (based on our previous experience with nasal, oral and injected delivery) to ensure we generate sufficient responses we can measure. We may be able to draw some tentative conclusions about differences in character of immune responses following sublingual or injected delivery, but it is not the intention of this initial study to formally compare these two routes. If we observe that sublingual delivery in humans can induce immune responses, we can select assays to test any differences more formally in subsequent bigger and more focused studies.

Being tested
Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads
Keywords
mucosal immunity, immunization, sublingual
Medical subject headings
Sexually Transmitted Diseases, Viral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum adsBiological

    Also called Gardasil

    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

  • Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum adsBiological

    Also called Gardasil

    1 sublingual application on month 0, 1 and 4 of 0.5 ml 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

Study groups in NCT00949572
Study groupRoleWhat they receive
Intramuscular administrationExperimentalIntramuscular injection of HPV vaccine proteins
Receives: Biological: Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads
Sublingual administrationExperimentalSublingual administration of HPV vaccine proteins
Receives: Biological: Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 0, 1, 4 and 5 months after first immunization

Secondary outcomes (4)

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

    Measured: 0, 1, 4 & 5 months after first immunization

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

    Measured: 0 and 1 week after each immunization

  3. 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

    Measured: 0 and 4 weeks after each immunization

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

    Measured: 0 and 4 weeks after each immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949572
Sponsor's protocol ID
SG09-EN01
Other IDs
REC number: 09/80803/77, EC grant number 201038
Status last verified
Jan 2010
First submitted
29 Jul 2009
Last updated
27 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22438987

Questions about this trial

What is this clinical trial studying?

A study testing Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads in people with Sexually Transmitted Diseases, Viral, run by St George's, University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00949572, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in