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Trial record 9 of 38 for:    Recruiting, Not yet recruiting, Available Studies | Chlamydia

Safety and Immunogenicity of a Chlamydia Vaccine CTH522 (CHLM-02)

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ClinicalTrials.gov Identifier: NCT03926728
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Statens Serum Institut

Brief Summary:
The present trial is a phase I, double-blind, parallel, randomised, and placebo-controlled trial of a chlamydia vaccine CTH522. Sixty-six subjects will be randomly assigned into six cohorts and are to receive four vaccination, in total of 12 trial visits. Cohorts A-D investigates CTH522-CAF01 administered IM in two doses (85 µg and 15 µg). Cohort E investigate CTH522-CAF09b also administered IM in one dose (85 µg). Cohort E is the placebo group. All subjects will receive a TO administration as a boost at Day 140 (4th vaccination). The TO boost will be non-adjuvanted CTH522 (12µg in each eye) or placebo. Nine subjects in each of cohorts A-E will receive the active boost (i.e. CTH522), three subjects will receive the placebo. The three placebo

Condition or disease Intervention/treatment Phase
Trachoma Biological: CTH522-CAF01 IM Biological: CTH522-CAF09b IM Biological: CTH522 ID Biological: CTH522 TO Biological: Placebo (Saline) Phase 1

Detailed Description:

This trial is a phase I, double-blind, parallel, randomised, and placebo-controlled trial of the chlamydia vaccine CTH522 in healthy adults.

Sixty-six subjects will be randomly assigned into six cohorts and are to receive four vaccination, in total of 12 trial visits (Table 3). Cohorts A-D investigates CTH522-CAF01 administered IM in two doses (85 µg and 15 µg). Cohort E investigate CTH522-CAF09b also administered IM in one dose (85 µg). Cohort E is the placebo group. All subjects will receive a TO administration as a boost at Day 140 (4th vaccination). The TO boost will be non-adjuvanted CTH522 (12µg in each eye) or placebo. Nine subjects in each of cohorts A-E will receive the active boost (i.e. CTH522), three subjects will receive the placebo. The three placebo subjects from each cohort will be grouped and will serve as control for the active boost.

  • Cohorts A will receive three IM vaccination of 85µg CTH522-CAF01. This cohort is divided into two groups: A1 will receive placebo at DAY 28 + Day 112 + Day 140, while A2 will receives placebo at Day 28 + Day 112, but non-adjuvanted TO CTH522 boost at Day 140.
  • Cohort B will receive three IM vaccination of 85 µg CTH522-CAF01. This cohort is divided into two groups: B1 will receive TO vaccination of the non-adjuvanted CTH522 at Day 28 + Day 112 and TO placebo at Day 140, while B2 will receive the same for Day 28 + Day 112, but non-adjuvanted TO CTH522 boost at Day 140. The two additional doses TO CTH522 (12µg) is administered in each eye. The rationale for this cohort is to investigate the impact of simultaneous TO administration of the antigen on the immunogenicity results obtained.
  • Cohort C will receive three IM vaccination of 85 µg CTH522-CAF01. This cohort is divided into two groups: C1 will receive ID vaccination of the non-adjuvanted CTH522 at Day 28 + Day 12 and TO placebo at Day 140, while C2 will receive the same for Day 28 + Day 112, but TO CTH522 boost at Day 140. The two additional doses of non-adjuvanted CTH522 (24µg) is administered ID. The rationale for this cohort is to investigate the impact of simultaneous ID administration of the antigen on the immunogenicity results obtained.
  • Cohort D is the same as cohort A except that the dose for CTH522-CAF01 is 15µg.
  • Cohort E is the same as cohort A except that the adjuvant is CAF09b and not CAF01. The rationale for the A, D and E cohorts is to investigate the impact of the CTH522 dose and adjuvant on the immunogenicity results.
  • Cohort F will receive only placebo in the form of 0.9% NaCl saline.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I, Double-blind, Parallel, Randomised and Placebo-controlled Trial Investigating the Safety and Immunogenicity of a Chlamydia Vaccine CTH522 in Healthy Adults
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A - 85µg CTH522-CAF01
Cohorts A will receive three IM vaccination of 85µg CTH522-CAF01. This cohort is divided into two groups: A1 will receive placebo at DAY 28 + Day 112 + Day 140, while A2 will receives placebo at Day 28 + Day 112, but non-adjuvanted TO CTH522 boost at Day 140.
Biological: CTH522-CAF01 IM
On-site reconstitution of IMPs is performed by mixing 85 microgram CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 ml polypropylene Luer-Lok™ syringe via 23-25-gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: CTH522 TO
24 microgram CTH522 (12 microgram in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: Placebo (Saline)
Placebo only given as IM, ID and TO

Experimental: Cohort B - 85µg CTH522-CAF01+ TO CTH522
Cohort B will receive three IM vaccination of 85 µg CTH522-CAF01. This cohort is divided into two groups: B1 will receive TO vaccination of the non-adjuvanted CTH522 at Day 28 + Day 112 and TO placebo at Day 140, while B2 will receive the same for Day 28 + Day 112, but non-adjuvanted TO CTH522 boost at Day 140. The two additional doses TO CTH522 (12µg) is administered in each eye. The rationale for this cohort is to investigate the impact of simultaneous TO administration of the antigen on the immunogenicity results obtained.
Biological: CTH522-CAF01 IM
On-site reconstitution of IMPs is performed by mixing 85 microgram CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 ml polypropylene Luer-Lok™ syringe via 23-25-gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: CTH522 TO
24 microgram CTH522 (12 microgram in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: Placebo (Saline)
Placebo only given as IM, ID and TO

Experimental: Cohort C - 85µg CTH522-CAF01+ID CTH522
Cohort C will receive three IM vaccination of 85 µg CTH522-CAF01. This cohort is divided into two groups: C1 will receive ID vaccination of the non-adjuvanted CTH522 at Day 28 + Day 12 and TO placebo at Day 140, while C2 will receive the same for Day 28 + Day 112, but TO CTH522 boost at Day 140. The two additional doses of non-adjuvanted CTH522 (24µg) is administered ID. The rationale for this cohort is to investigate the impact of simultaneous ID administration of the antigen on the immunogenicity results obtained.
Biological: CTH522-CAF01 IM
On-site reconstitution of IMPs is performed by mixing 85 microgram CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 ml polypropylene Luer-Lok™ syringe via 23-25-gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: CTH522 ID
24 microgram CTH522 given ID is in the non-dominant deltoid muscle. ID with a 1 ml syringe via a 26-28 gauge needle using a NanoPass device or similar. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: Placebo (Saline)
Placebo only given as IM, ID and TO

Experimental: Cohort D - 15µg CTH522-CAF01
Cohort D is the same as cohort A except that the dose for CTH522-CAF01 is 15µg.
Biological: CTH522-CAF01 IM
On-site reconstitution of IMPs is performed by mixing 85 microgram CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 ml polypropylene Luer-Lok™ syringe via 23-25-gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: CTH522 TO
24 microgram CTH522 (12 microgram in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: Placebo (Saline)
Placebo only given as IM, ID and TO

Experimental: Cohort E - 85µg CTH522-CAF09b
Cohort E is the same as cohort A except that the adjuvant is CAF09b and not CAF01. The rationale for the A, D and E cohorts is to investigate the impact of the CTH522 dose and adjuvant on the immunogenicity results.
Biological: CTH522-CAF09b IM
On-site reconstitution of IMPs is performed by mixing 85 microgram CTH522 with CAF09b. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 ml polypropylene Luer-Lok™ syringe via 23-25-gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

Biological: Placebo (Saline)
Placebo only given as IM, ID and TO

Placebo Comparator: Cohort F - Placebo
Cohort F will receive only placebo in form of 0.9% NaCl saline.
Biological: Placebo (Saline)
Placebo only given as IM, ID and TO




Primary Outcome Measures :
  1. Local injection reactions [ Time Frame: Visit 2 (Day 0) to Visit 12 (Day 238) ]
    Local injection site reactions after intramuscular and intradermal vaccination

  2. Local ocular reactions [ Time Frame: Visit 2 (Day 0) to Visit 12 (Day 238) ]
    Local ocular reactions after topical ocular vaccination

  3. Systemic reactions [ Time Frame: Visit 2 (Day 0) to Visit 12 (Day 238) ]
    Systemic reactions after vaccinations


Secondary Outcome Measures :
  1. Secondary - immunogenicity [ Time Frame: Visit 2 (Day 0) to Visit 12 (Day 238); except for Visit 10 (Day 143) ]
    Seroconversion for anti-CTH522 IgG at any time points after vaccinations of CTH522


Other Outcome Measures:
  1. Exploratory - immunogenicity [ Time Frame: Visit 2 (Day 0) to Visit 12 (Day 238) ]

    Systemic, and ocular antibodies; Cell-mediated immune response; Antibody responses measured by B-cell

    o Serum neutralising antibodies against serovars D-G




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Healthy males and females between 18-45 years old on the day of the first vaccination
  • Has been properly informed about the trial and signed the consent form
  • Is willing and likely to comply with the trial procedures
  • Is prepared to grant an authorised person access to their trial-related medical record
  • Willing to use acceptable contraceptive measures during the trial (two weeks before and two weeks after the trial). Heterosexually active female capable of becoming pregnant must (in addition to requiring a male partner to use condoms) agrees to use hormonal contraception, an intrauterine device, intrauterine hormone-releasing system, or to complete abstinence, from at least two weeks before the first vaccination until at least two weeks after the last. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), withdrawal 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:

  • Is positive for C. trachomatis via urine PCR or has a known history of C. trachomatis
  • Is positive for gonorrhoea via a urine PCR test, or HIV, Hepatitis B/C, syphilis via blood tests
  • Has a significant active disease such as cardiac, liver, immunological, neurological, psychiatric or any ocular diseases, or clinically significant abnormality of haematological or biochemical parameters
  • Has body mass index of ≥ 35 kg/m2
  • Is currently participating in another clinical trial with an investigational or non-investigational drug or device
  • Has received, or plans to receive, any immunisation within 14 days of the start of the trial or any of the immunisation visits during the 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 or ID injection site
  • 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
  • Unable to refrain from use of contact lenses. Contact lenses should be avoided two days before TO administration and for three days later (longer if any ongoing local eye AE).
  • Any evident ocular disease upon ophthalmoscopic exam at screening
  • Is pregnant (positive pregnancy test) or breastfeeding or not willing to use contraception during the trial
  • Has confirmed history of pelvic inflammatory disease or significant gynaecological diseases

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): NCT03926728


Contacts
Layout table for location contacts
Contact: Peter Bang +4532688191 PBA@ssi.dk
Contact: Lina Stoey +4532683193 LSST@ssi.dk

Sponsors and Collaborators
Statens Serum Institut
Imperial College London
Investigators
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Study Director: Ingrid Kromann Statens Serum Institut
Principal Investigator: Frederica Borghese, MD Imperial Clinical Tesearch Facility Hammersmith Hospital

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Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT03926728     History of Changes
Other Study ID Numbers: CHLM-02
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Statens Serum Institut:
CTH522
Chlamydia
C. Trachomatis

Additional relevant MeSH terms:
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Chlamydia Infections
Trachoma
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Eye Infections
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs