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Cervicovaginal Immune Responses to 3 Deltoid or Thigh Intramuscular (IM) TicoVac (CRC306)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01710189
First received: October 16, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

Many viral infections of global importance, including HIV, are transmitted across the mucosal surface of the genital tract. As immunity against these infections is likely to be primarily mediated by antibodies in mucosal secretions, developing techniques to increase the levels and persistence of antiviral antibody on mucosal surfaces may enhance the protection against a number of important infections. Preclinical studies have anatomically targeted vaccine antigens to sites where genital tract immunity is induced. This response is likely due to the ability of regional lymph Preclinical studies have anatomically targeted vaccine antigens to sites where genital tract immunity is induced. This response is likely due to the ability of regional lymph nodes to "pattern" the cell surface markers of responding vaccine specific lymphocytes with homing markers. In contrast, injecting a distant muscle (such as in the arm) which shares no anatomical relationship with the vagina, may not pattern cells with homing markers for the genital tract. Direct injection of inguinal lymph nodes is impractical in humans but intramuscular injection into the thigh will target antigens to the deep inguinal lymph nodes shared in common with the cervix/vagina.

This study will be a Phase IV randomised, single centre, open label, laboratory assessment blinded exploratory trial to assess mucosal immunogenicity following three targeted intramuscular immunisations with TicoVac vaccine. 20 subjects will be randomised to each of2 groups immunised in right deltoid or right anterolateral thigh.

Following an initial screening visit subjects will be immunised at 0, 1 and 6 months. There will be follow up visits 5 days after each immunisation and a final visit at 7 months. Blood samples and cervicovaginal secretions will be taken prior to each immunisation for immunological measures. In addition, blood samples will be taken at each immunisation and follow up visit for measurement of peripheral blood mononuclear cells.

The study is funded by ADITEC, which is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.


Condition Intervention Phase
Tick-Borne Encephalitis
Drug: TicoVac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Clinical Trial of Cervico-vaginal Immune Responses Following Three Right Deltoid or Right Thigh Intramuscular Immunisations With TicoVac (Tick Borne Encephalitis Virus [TBEV]) Vaccine in Adult Female Participants

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Primary: Proportion of subjects with a 15-fold or greater increase from pre-immunisation levels of anti-TBEV IgG in cervico-vaginal secretions at 28 days after final immunisation. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    To determine whether immunisations in the anterolateral right thigh increases the proportion of subjects with a 15-fold or greater increase from pre-immunisation levels of anti-TBEV IgG in cervico-vaginal secretions at 28 days after final immunisation when compared with immunisations in the right arm


Secondary Outcome Measures:
  • Secondary: Proportion of subjects with a 2-fold or greater increase from pre-immunisation levels of anti-TBEV IgA in cervico-vaginal secretions at 28 days after final immunisation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    To determine whether immunisations in the anterolateral right thigh increases the proportion of subjects with a 2-fold or greater increase from pre-immunisation levels of anti-TBEV IgA in cervico-vaginal secretions at 28 days after final immunisation when compared with immunisations in the right arm


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TicoVac immunisation
IM immunisation right deltoid muscle
Drug: TicoVac
Intramuscular immunisation to right deltoid muscle (Group 1) or right upper anterolateral thigh muscle (Group 2).
Experimental: TicoVac immunisation
IM: right upper anterolateral thigh
Drug: TicoVac
Intramuscular immunisation to right deltoid muscle (Group 1) or right upper anterolateral thigh muscle (Group 2).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Women aged between 18 and 49 years on the day of screening.
  • Available for follow-up for the duration of the study.
  • Willing and able to give written informed consent.
  • Agree to abstain from donating blood during and for three months after the end of their participation in the trial, or longer if necessary.
  • Willing to abstain from vaginal intercourse for 12 hours prior to cervico-vaginal secretions sampling.

Exclusion criteria

  • Previous immunisation with a TBEV vaccine or history of TBEV infection.
  • Previous immunisation with a Yellow Fever or Japanese B encephalitis vaccine, or history of infection with Yellow fever, Japanese B encephalitis, hepatitis C and dengue infection (as antibodies against these viruses cross react with TBE). Immunisation with Yellow Fever or Japanese B encephalitis vaccine or diagnosis of any of these infections during the study period will exclude the subject.
  • Intention to travel to an area requiring immunisation against Japanese B encephalitis within 40 days and yellow fever within 10 days of the expected last visit(as Japanese B encephalitis vaccine requires two immunisations 28 days apart and must be completed within 10 days of departure. Yellow Fever vaccination becomes effective 10 days after a single immunisation)
  • Any Intra Uterine Contraceptive Device (as this contraindicates with use of the Softcup).
  • Pregnant or lactating at time of screening or immunisations.
  • Known hypersensitivity to the vaccine active substance, any of the excipients, or the production residues (formaldehyde, neomycin, gentamicin, protamine sulphate).
  • Latex allergy.
  • Severe hypersensitivity to egg and chick proteins ("severe" means anaphylactic reaction after oral ingestion of egg protein - other reactions are not exclusions).
  • Clinically relevant abnormality on history including uncontrolled infection; autoimmune disease, immunodeficiency, or pre-existing cerebral disorders.
  • Any drugs and categories of drugs listed in Appendix 1, by the routes indicated, and at any time during the study period, or for the period preceding screening indicated in Appendix 1.

Any medications that are not listed in Appendix 1,or any over-the-counter treatments are not excluded.

Receipt of vaccines other than TBEV vaccines is not excluded. If other injectable vaccines are to be given during the study period, administration should preferably be into different limbs from the study vaccine.

  • Receipt of blood products or immunoglobin within 3 months of screening.
  • Participation in another trial of a medicinal product, completed less than 90 days prior to visit 2.
  • Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
  • Unlikely to comply with protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710189

Locations
United Kingdom
Surrey CRC, Egerton Road
Guildford, Surrey, United Kingdom, GU2 7XP
Sponsors and Collaborators
University of Surrey
  More Information

Additional Information:
No publications provided

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01710189     History of Changes
Other Study ID Numbers: CRC306
Study First Received: October 16, 2012
Last Updated: June 5, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Surrey:
Tick-Borne Encephalitis Virus

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Tick-Borne Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014