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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

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date August 10, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02787109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chlamydia Trachomatis
Intervention  ICMJE
  • Biological: CTH522-CAF01
    CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration
  • Biological: CTH522-Al(OH)3
    CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration
  • Biological: Placebo
    Saline
Study Arms  ICMJE
  • 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

    Intervention: Biological: CTH522-CAF01
  • 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

    Intervention: Biological: CTH522-Al(OH)3
  • Placebo Comparator: Placebo
    Saline for IM and In administrations
    Intervention: Biological: Placebo
Publications * Abraham S, Juel HB, Bang P, Cheeseman HM, Dohn RB, Cole T, Kristiansen MP, Korsholm KS, Lewis D, Olsen AW, McFarlane LR, Day S, Knudsen S, Moen K, Ruhwald M, Kromann I, Andersen P, Shattock RJ, Follmann F. Safety and immunogenicity of the chlamydia vaccine candidate CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2019 Oct;19(10):1091-1100. doi: 10.1016/S1473-3099(19)30279-8. Epub 2019 Aug 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2016)
35
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787109
Other Study ID Numbers  ICMJE CHLM-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Statens Serum Institut
Study Sponsor  ICMJE Statens Serum Institut
Collaborators  ICMJE Imperial College London
Investigators  ICMJE
Principal Investigator: Sonya Abraham Imperial College London
PRS Account Statens Serum Institut
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP