Safety and Immunogenicity of a Chlamydia Vaccine CTH522
CHLM-02
A Phase I, Double-blind, Parallel, Randomised and Placebo-controlled Trial Investigating the Safety and Immunogenicity of a Chlamydia Vaccine, CTH522, in Healthy Adults
1 other identifier
interventional
65
1 country
1
Brief Summary
CHLM-02 was a phase I, double-blind, randomized, placebo-controlled trial of the chlamydia vaccine CTH522. 65 trial participants were randomized into 12 groups and six cohorts (A1 to F2). Cohorts A to E received three intramuscular (IM) injections of CTH522 (Day 0, 28, and 112). Cohorts A to D received CTH522 adjuvanted with Cationic Adjuvant Formulation (CAF®) 01 IM in two doses (85µg \[A to C\] or 15µg \[D\]). Cohort E received 85µg CTH522 adjuvanted with CAF®09b. Cohorts B and C received unadjuvanted CTH522 boost via the topic ocular (TO) or intradermal (ID) route, respectively, jointly with the second and third IM vaccinations. Cohort F received placebo. The effect of mucosal recall on eye immunity with TO CTH522 or placebo was assessed Day 140.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 24, 2019
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2022
CompletedResults Posted
Study results publicly available
August 22, 2024
CompletedAugust 22, 2024
March 1, 2024
2 years
April 15, 2019
August 2, 2023
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Visit 2 (Day 0) plus 14 Days
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Visit 4 (Day 28) plus 14 Days
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Visit 7 (Day 112) plus 14 Days
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Visit 4 (Day 28) plus 14 Days
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Visit 7 (Day 112) plus 14 Days
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Visit 9 (Day 140) plus 14 Days
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Visit 2 (Day 0) plus 14 Days
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Visit 4 (Day 28) plus 14 Days
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Visit 7 (Day 112) plus 14 Days
Secondary Outcomes (2)
Immunogenicity (4-fold Increase From Baseline)
Day 14, 28, 42, 56, 112, 126, 140, 154, 238
Immunogenicity (10-fold Increase From Baseline)
Day 14, 28, 42, 56, 112, 126, 140, 154, 238
Study Arms (6)
Cohort A 85 mcg CTH522-CAF01
EXPERIMENTALCohort A received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort A1 receives placebo at Day 28, 112, and 140, while cohort A2 received placebo at Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140.
Cohort B 85 mcg CTH522-CAF01 + TO CTH522
EXPERIMENTALCohort B received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140.
Cohort C 85 mcg CTH522-CAF01 + ID CTH522
EXPERIMENTALCohort C received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort C1 received ID vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort C2 received the same for Day 28 and 112, but TO CTH522 boost at Day 140.
Cohort D 15 mcg CTH522-CAF01
EXPERIMENTALCohort D received three IM vaccination of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort D1 received TO placebo given on Day 28, 112, and 140, while cohort D2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
Cohort E 85 mcg CTH522-CAF09b
EXPERIMENTALCohort E received three IM vaccination of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). This cohort was divided into two groups: Cohort E1 received TO placebo given on Day 28, 112, and 140, while cohort E2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
Cohort F Placebo
PLACEBO COMPARATORCohort F received three IM vaccinations of placebo in form of 0.9% NaCl saline (Day 0, 28, and 112).This cohort was divided into two groups: Cohort F1 received TO placebo given on Day 28, 112, and 140, while cohort F2 received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
Interventions
On-site reconstitution of IMPs is performed by mixing 85 mcg 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.
On-site reconstitution of IMPs is performed by mixing 85 mcg 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.
24 mcg 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.
24 mcg CTH522 (12 mcg 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.
Placebo only given as IM, ID and TO.
Eligibility Criteria
You may qualify if:
- 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 hormone releasing 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Statens Serum Institutlead
- Imperial College Londoncollaborator
Study Sites (1)
NIHR Imperial Center for Translational and Experimental Medicine
London, W12, United Kingdom
Related Publications (1)
Pollock KM, Borges AH, Cheeseman HM, Rosenkrands I, Schmidt KL, Sondergaard RE, Day S, Evans A, McFarlane LR, Joypooranachandran J, Amini F, Skallerup P, Dohn RB, Jensen CG, Olsen AW, Bang P, Cole T, Schronce J, Lemm NM, Kristiansen MP, Andersen PL, Dietrich J, Shattock RJ, Follmann F. An investigation of trachoma vaccine regimens by the chlamydia vaccine CTH522 administered with cationic liposomes in healthy adults (CHLM-02): a phase 1, double-blind trial. Lancet Infect Dis. 2024 Aug;24(8):829-844. doi: 10.1016/S1473-3099(24)00147-6. Epub 2024 Apr 11.
PMID: 38615673DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Screening and recruitment activities had to be paused during the trial due to the Covid-19 pandemic.
Results Point of Contact
- Title
- Per Skallerup
- Organization
- Statens Serum Institut
Study Officials
- STUDY DIRECTOR
Alvaro Borges, MD
Statens Serum Institut
- PRINCIPAL INVESTIGATOR
Katrina Pollock, MD
Imperial Clinical Research Facility Hammersmith Hospital
- STUDY CHAIR
Lina S Stoey, MPH
Statens Serum Institut
- STUDY CHAIR
Pernille N Tingskov, BS
Statens Serum Institut
- STUDY CHAIR
Rebecca B Dohn, Pharm
Statens Serum Institut
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 24, 2019
Study Start
February 17, 2020
Primary Completion
February 22, 2022
Study Completion
February 22, 2022
Last Updated
August 22, 2024
Results First Posted
August 22, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share