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Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

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ClinicalTrials.gov Identifier: NCT02787109
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : August 10, 2017
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Statens Serum Institut

Brief Summary:

The present trial is a phase I first in human, double blind, parallel and placebo controlled trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in the United Kingdom.

Subjects are randomly assigned to one of the following three treatment groups in a ratio of 3:3:1.

This trial consisted of 10 visits and 5 telephonic interviews


Condition or disease Intervention/treatment Phase
Chlamydia Trachomatis Biological: CTH522-CAF01 Biological: CTH522-Al(OH)3 Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I First in Human, Double-blind, Parallel, Randomised and Placebo Controlled Clinical Trial of the Safety of SSI's Adjuvanted Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
Study Start Date : July 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CTH522-CAF01

CTH522-CAF01: CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration (preferably the non-dominant arm)

CTH522 chlamydia antigen diluted with Tris buffer for IN administration

Biological: CTH522-CAF01
CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration

Experimental: CTH522-Al(OH)3

CTH522-Al(OH)3: CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration (preferably the non-dominant arm)

CTH522 chlamydia antigen diluted with Tris buffer for IN administration

Biological: CTH522-Al(OH)3
CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration

Placebo Comparator: Placebo
Saline for IM and In administrations
Biological: Placebo
Saline




Primary Outcome Measures :
  1. Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine [ Time Frame: Through study completion (Day 0 to Day 168) ]
    Solicited local injection site reactions (recorded at any visit) after intramuscular (IM) administration (pain, erythema, tenderness, pruritus, warmth, stiffness and swelling) Solicited local reactions (recorded at any visit) after IN administration (discharge, including bleeding, congestion, discomfort, sneezing and cough) Solicited systemic reactions (recorded at any visit) after IM and IN administration (abnormally raised temperature, chills, myalgia, malaise, fatigue, rash, headache, nausea and vomiting, and clinically significant abnormal values among full blood count, liver function test and renal profile results)


Secondary Outcome Measures :
  1. Serum immunoglobulin G antibody responses after vaccination with CTH522 [ Time Frame: At Days 0, 28, 112, 126, 140, 154 and 168 ]
    Percentage of subjects achieving seroconversion for anti-CTH522 immunoglobulin G antibody at any time points after IM vaccination(s)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is a healthy female between 18 and 45 years of age on the day of first trial vaccination
  2. Has provided signed informed consent
  3. Is willing and likely to comply with the trial procedures
  4. Is prepared to grant authorised persons access to their medical record
  5. Willing to use acceptable contraceptive measures* during the trial (2 weeks before and 2 weeks after the trial)

    • Heterosexually active female capable of becoming pregnant must (in addition to requiring male partner to use condoms) agree to use hormonal contraception, or to complete abstinence, from at least 2 weeks before the first vaccination until at least 2 weeks after the last. (Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal and intrauterine device or intrauterine hormone releasing system and progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, are not acceptable methods of contraception)

Exclusion Criteria:

  1. Has confirmed history of Pelvic Inflammatory Disease or significant gynaecological diseases
  2. Is positive for C. trachomatis (PCR)
  3. Is positive for gonorrhoea (urine), HIV, Hepatitis B/C, syphilis (blood)
  4. Has a positive pregnancy test
  5. Has a significant active disease - such as cardiac, liver, immunological, neurological, psychiatric; or clinically significant abnormality of haematological or biochemical parameters.
  6. Has BMI of 35 kg/m2 or greater
  7. Is currently participating in another clinical trial with an investigational or noninvestigational drug or device
  8. Has received, or plans to receive, an active immunisation within 14 days of the start of the trial or any of the immunisation visits in this trial
  9. Is currently receiving treatment with immunosuppressive agents e.g. oral, inhaled, nasal or injected corticosteroids. (Topical steroids are allowed, unless applied to the IM injection site.)
  10. Is using an intrauterine device
  11. Has a condition which in the opinion of the investigator is not suitable for participation in the trial
  12. Known or confirmed allergy to any of the vaccine constituents -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787109


Locations
United Kingdom
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Statens Serum Institut
Imperial College London
Investigators
Principal Investigator: Sonya Abraham Imperial College London

Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT02787109     History of Changes
Other Study ID Numbers: CHLM-01
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Statens Serum Institut:
Safety
Immunogenicity
Phase I

Additional relevant MeSH terms:
Chlamydia Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Genital Diseases, Male
Genital Diseases, Female
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents