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

Primary Purpose

Chlamydia Trachomatis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
CTH522-CAF01
CTH522-Al(OH)3
Placebo
Sponsored by
Statens Serum Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chlamydia Trachomatis focused on measuring Safety, Immunogenicity, Phase I

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CTH522-CAF01

CTH522-Al(OH)3

Placebo

Arm Description

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

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

Saline for IM and In administrations

Outcomes

Primary Outcome Measures

Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine
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

Serum immunoglobulin G antibody responses after vaccination with CTH522
Percentage of subjects achieving seroconversion for anti-CTH522 immunoglobulin G antibody at any time points after IM vaccination(s)

Full Information

First Posted
May 23, 2016
Last Updated
August 8, 2017
Sponsor
Statens Serum Institut
Collaborators
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT02787109
Brief Title
Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Statens Serum Institut
Collaborators
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis
Keywords
Safety, Immunogenicity, Phase I

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTH522-CAF01
Arm Type
Experimental
Arm Description
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
Arm Title
CTH522-Al(OH)3
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline for IM and In administrations
Intervention Type
Biological
Intervention Name(s)
CTH522-CAF01
Intervention Description
CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration
Intervention Type
Biological
Intervention Name(s)
CTH522-Al(OH)3
Intervention Description
CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine
Description
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)
Time Frame
Through study completion (Day 0 to Day 168)
Secondary Outcome Measure Information:
Title
Serum immunoglobulin G antibody responses after vaccination with CTH522
Description
Percentage of subjects achieving seroconversion for anti-CTH522 immunoglobulin G antibody at any time points after IM vaccination(s)
Time Frame
At Days 0, 28, 112, 126, 140, 154 and 168

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is a healthy female between 18 and 45 years of age on the day of first trial vaccination Has provided signed informed consent Is willing and likely to comply with the trial procedures Is prepared to grant authorised persons access to their medical record 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: Has confirmed history of Pelvic Inflammatory Disease or significant gynaecological diseases Is positive for C. trachomatis (PCR) Is positive for gonorrhoea (urine), HIV, Hepatitis B/C, syphilis (blood) Has a positive pregnancy test Has a significant active disease - such as cardiac, liver, immunological, neurological, psychiatric; or clinically significant abnormality of haematological or biochemical parameters. Has BMI of 35 kg/m2 or greater Is currently participating in another clinical trial with an investigational or noninvestigational drug or device 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 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.) Is using an intrauterine device Has a condition which in the opinion of the investigator is not suitable for participation in the trial Known or confirmed allergy to any of the vaccine constituents -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonya Abraham
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31416692
Citation
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.
Results Reference
derived

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

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