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

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ClinicalTrials.gov Identifier: NCT03926728
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : March 6, 2020
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.

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.

It is planned to randomly assign 66 subjects into six cohorts. Cohorts A-D investigate CTH522-CAF01 administered IM in two doses (85 μg and 15 μg). Cohort E investigates CTH522-CAF09b administered IM in one dose (85 μg). Cohort F is the placebo group. The enrolled subjects will complete 12 trial visits. All subjects in the active groups (cohort A-E) will receive three IM injections of the adjuvanted CTH522 and some (cohort B and C) will receive the non-adjuvanted CTH522 via the TO or ID route (given at the same time as the 2nd and 3rd IM vaccinations). All active groups will receive TO administration as a boost at Day 140 of either the non-adjuvanted CTH522 (12 μg in each eye) or placebo.

  • Cohort A will receive three IM vaccination of 85μg CTH522-CAF01. This cohort is divided into two groups: A1 will receive ID placebo at Day 28 + Day 112, and TO placebo at Day 140, while A2 will receive TO placebo at Day 28 + Day 112, and non-adjuvanted TO CTH522 boost at Day 140.
  • Cohort B will receive three IM vaccinations 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 and 112 and TO placebo at Day 140, while B2 will receive the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140. The two additional TO doses of CTH522 (12 μg in each eye) are administered in each eye. The rationale for this schedule is to investigate the impact of simultaneous TO administration of the antigen on the immunogenicity results.
  • Cohort C will receive three IM vaccinations of 85 μg CTH522-CAF01. This cohort is divided into two groups: C1 will receive ID vaccination of the non-adjuvanted 24 μg CTH522 at Day 28 and 112 and TO placebo at Day 140, while C2 will receive the same for Day 28 and 112, but TO 12 μg CTH522 boost in each eye at Day 140. The rationale for this schedule is to investigate the impact of simultaneous ID administration of the antigen on the immunogenicity results.
  • Cohort D will receive three IM vaccinations of 15 μg CTH522-CAF01. The rationale for the A and D cohorts is to investigate the impact of the two IM CTH522 doses on the immunogenicity results.
  • Cohort E will receive three IM vaccinations of 85 μg CTH522-CAF09b. The rationale for the A and E cohorts is to investigate the impact of the adjuvant on the immunogenicity results.
  • Cohort F will receive only placebo in the form of 0.9% NaCl saline (IM, ID and TO).

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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
Actual Study Start Date : February 17, 2020
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); except for Visit 3 (Day 14) for ocular strip ]

    Systemic and ocular antibodies: cell-mediated immune response, antibody responses measured by T- and B-cell Elispot, serum neutralising antibodies against serovars D-G.

    Isolation and characterisation of CTH522-antigen-specific memory B-cells in the systemic compartments (dependent on the elicited specific memory T- and B-cell numbers)




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:

IC1: Healthy males and females between 18-45 years old on the day of the first vaccination IC2: Has been properly informed about the trial and signed the consent form IC3: Is willing and likely to comply with trial procedures IC4: Is prepared to grant authorised persons access to his/her trial-related medical record IC5: Is 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 agree to use hormonal contraception, intrauterine device, intrauterine hormonereleasing system, or to complete abstinence from at least two weeks before the first vaccination until at least two weeks after the last. Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the subject. 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:

EX1: Is positive for C. trachomatis via urine PCR or has a known history of C. trachomatis EX2: Is positive for gonorrhoea via urine PCR test, or HIV, hepatitis B/C, syphilis via blood tests EX3: Has a significant active disease such as cardiac, liver, immunological, neurological, psychiatric or clinically significant abnormality of haematological or biochemical parameters EX4: Has BMI ≥ 35 kg/m2 EX5: Is currently participating in another clinical trial with an investigational or noninvestigational drug or device, or was treated with an investigational drug within 28 days before the first vaccination EX6: Has received, or plans to receive, any immunisation within 14 days of the start of the trial or during the trial immunisations EX7: Is currently receiving treatment with systemic immunosuppressive agents. Topical steroids are allowed unless applied to the IM or ID injection site EX8: Has a condition which in the opinion of the investigator is not suitable for participation in the trial EX9: Is known or confirmed to have an allergy to any of the vaccine constituents EX10: Is unable to refrain from the use of contact lenses. Contact lenses should be avoided two days before TO administration and for seven days later (longer if any ongoing local eye AE) EX11: Has any evident ocular disease upon ophthalmoscopic exam at screening or any medical history of ocular disease that, in the opinion of the investigator, may impact the subject's participation in the trial EX12: Is pregnant (positive pregnancy test) or breastfeeding or not willing to use contraception during the trial EX13: Has confirmed a 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
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Contact: Peter Bang +4532688191 PBA@ssi.dk
Contact: Lina Stoey +4532683193 LSST@ssi.dk

Locations
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United Kingdom
NIHR Imperial Center for Translational and Experimental Medicine Recruiting
London, United Kingdom, W12
Contact: Tom Cole, PhD    0203 313 6198      
Principal Investigator: Katrina Pollock, MD         
Sponsors and Collaborators
Statens Serum Institut
Imperial College London
Investigators
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Study Director: Alvaro Borges, MD Statens Serum Institut
Principal Investigator: Katrina Pollock, MD Imperial Clinical Tesearch Facility Hammersmith Hospital
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Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT03926728    
Other Study ID Numbers: CHLM-02
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
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
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Eye Infections
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases