TrachomaPhase 1CHLM-02NCT03926728

Safety and Immunogenicity of a Chlamydia Vaccine CTH522

A Phase 1 study testing CTH522-CAF01 IM, CTH522-CAF09b IM and CTH522 ID in people with Trachoma, run by Statens Serum Institut at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Trachoma
What is being tested?: CTH522-CAF01 IM, CTH522-CAF09b IM and CTH522 ID
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteUnited Kingdom
Study dates: 17 Feb 2020to 22 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

NIHR Imperial Center for Translational and Experimental Medicine
London, W12

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

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

It was planned to randomize 66 subjects but only 65 subjects were randomized. Cohorts A-D investigated CTH522-CAF01 administered IM in two doses (85 mcg and 15 mcg). Cohort E investigated CTH522-CAF09b administered IM in one dose (85 mcg). Cohort F was the placebo group. The enrolled subjects were to complete 12 trial visits. All subjects in the active cohorts (cohort A-E) were to receive three IM injections of the adjuvanted CTH522 and some (cohort B and C) were to 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 cohorts were to receive TO administration as a boost at Day 140 of either the non-adjuvanted CTH522 (12 mcg in each eye) or placebo.

Cohort A received three IM vaccination of 85 mcg CTH522-CAF01. This cohort was divided into two groups: A1 received ID placebo at Day 28 and Day 112, and TO placebo at Day 140, while A2 received TO placebo at Day 28 and Day 112, and non-adjuvanted TO CTH522 boost at Day 140.
Cohort B received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140. The two additional TO doses of CTH522 (12 mcg in each eye) were administered in each eye. The rationale for this schedule was to investigate the impact of simultaneous TO administration of the antigen on the immunogenicity results.
Cohort C received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: C1 received ID vaccination of the non-adjuvanted 24 mcg CTH522 at Day 28 and 112 and TO placebo at Day 140, while C2 received the same for Day 28 and 112, but TO 12 mcg CTH522 boost in each eye at Day 140. The rationale for this schedule was to investigate the impact of simultaneous ID administration of the antigen on the immunogenicity results.
Cohort D received three IM vaccinations of 15 mcg CTH522-CAF01. The rationale for the A and D cohorts was to investigate the impact of the two IM CTH522 doses on the immunogenicity results.
Cohort E received three IM vaccinations of 85 mcg CTH522-CAF09b. The rationale for the A and E cohorts was to investigate the impact of the adjuvant on the immunogenicity results.
Cohort F received placebo in the form of 0.9% NaCl saline (IM, ID and TO).

Conditions: Trachoma
Being tested: CTH522-CAF01 IM, CTH522-CAF09b IM, CTH522 ID, CTH522 TO, Placebo (Saline)
Keywords: CTH522, Chlamydia, C. Trachomatis
Medical subject headings: Trachoma, Chlamydia Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTH522-CAF01 IMBiological
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.
CTH522-CAF09b IMBiological
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.
CTH522 IDBiological
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.
CTH522 TOBiological
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 (Saline)Biological
Placebo only given as IM, ID and TO.

Study groups in NCT03926728
Study group	Role	What they receive
Cohort A 85 mcg CTH522-CAF01	Experimental	Cohort 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. Receives: Biological: CTH522-CAF01 IM; Biological: CTH522 TO; Biological: Placebo (Saline)
Cohort B 85 mcg CTH522-CAF01 + TO CTH522	Experimental	Cohort 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. Receives: Biological: CTH522-CAF01 IM; Biological: CTH522 TO; Biological: Placebo (Saline)
Cohort C 85 mcg CTH522-CAF01 + ID CTH522	Experimental	Cohort 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. Receives: Biological: CTH522-CAF01 IM; Biological: CTH522 ID; Biological: CTH522 TO; Biological: Placebo (Saline)
Cohort D 15 mcg CTH522-CAF01	Experimental	Cohort 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. Receives: Biological: CTH522-CAF01 IM; Biological: CTH522 TO; Biological: Placebo (Saline)
Cohort E 85 mcg CTH522-CAF09b	Experimental	Cohort 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. Receives: Biological: CTH522-CAF09b IM; Biological: CTH522 TO; Biological: Placebo (Saline)
Cohort F Placebo	Placebo comparator	Cohort 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. Receives: Biological: Placebo (Saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 7 (Day 112) plus 14 Days

Secondary outcomes (2)

Immunogenicity (4-fold Increase From Baseline)
Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Measured: Day 14, 28, 42, 56, 112, 126, 140, 154, 238
Immunogenicity (10-fold Increase From Baseline)
Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Measured: Day 14, 28, 42, 56, 112, 126, 140, 154, 238

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 202022 Feb 2022

First posted24 Apr 2019
Study start17 Feb 2020
Primary completion22 Feb 2022
Study completion22 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TrachomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03926728
Sponsor's protocol ID: CHLM-02
Acronym: CHLM-02
Status last verified: Mar 2024
First submitted: 15 Apr 2019
Last updated: 22 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38615673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03926728
Acronym / sponsor ID: CHLM-02 / CHLM-02
Conditions: Trachoma
Keywords: CTH522, Chlamydia, C. Trachomatis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Statens Serum InstitutUniversity, hospital or other
Collaborators: Imperial College London
Study start: 17 Feb 2020 (actual)
Primary completion: 22 Feb 2022 (actual)
Study completion: 22 Feb 2022 (actual)
First posted: 24 Apr 2019 (actual)
Results: Posted 22 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Cohort A received three IM vaccination of 85 mcg CTH522-CAF01. This cohort was divided into two groups: A1 received ID placebo at Day 28 and Day 112, and TO placebo at Day 140, while A2 received TO placebo at Day 28 and Day 112, and non-adjuvanted TO CTH522 boost at Day 140.
Cohort B received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140. The two additional TO doses of CTH522 (12 mcg in each eye) were administered in each eye. The rationale for this schedule was to investigate the impact of simultaneous TO administration of the antigen on the immunogenicity results.
Cohort C received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: C1 received ID vaccination of the non-adjuvanted 24 mcg CTH522 at Day 28 and 112 and TO placebo at Day 140, while C2 received the same for Day 28 and 112, but TO 12 mcg CTH522 boost in each eye at Day 140. The rationale for this schedule was to investigate the impact of simultaneous ID administration of the antigen on the immunogenicity results.
Cohort D received three IM vaccinations of 15 mcg CTH522-CAF01. The rationale for the A and D cohorts was to investigate the impact of the two IM CTH522 doses on the immunogenicity results.
Cohort E received three IM vaccinations of 85 mcg CTH522-CAF09b. The rationale for the A and E cohorts was to investigate the impact of the adjuvant on the immunogenicity results.
Cohort F received placebo in the form of 0.9% NaCl saline (IM, ID and TO).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Cohort A 85 mcg CTH522-CAF01	Experimental	Biological: CTH522-CAF01 IM, Biological: CTH522 TO, Biological: Placebo (Saline)Cohort 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	Experimental	Biological: CTH522-CAF01 IM, Biological: CTH522 TO, Biological: Placebo (Saline)Cohort 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	Experimental	Biological: CTH522-CAF01 IM, Biological: CTH522 ID, Biological: CTH522 TO, Biological: Placebo (Saline)Cohort 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	Experimental	Biological: CTH522-CAF01 IM, Biological: CTH522 TO, Biological: Placebo (Saline)Cohort 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	Experimental	Biological: CTH522-CAF09b IM, Biological: CTH522 TO, Biological: Placebo (Saline)Cohort 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 comparator	Biological: Placebo (Saline)Cohort 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.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CTH522-CAF01 IMOn-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.	Biological	Cohort A 85 mcg CTH522-CAF01, Cohort B 85 mcg CTH522-CAF01 + TO CTH522, Cohort C 85 mcg CTH522-CAF01 + ID CTH522, Cohort D 15 mcg CTH522-CAF01
CTH522-CAF09b IMOn-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.	Biological	Cohort E 85 mcg CTH522-CAF09b
CTH522 ID24 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.	Biological	Cohort C 85 mcg CTH522-CAF01 + ID CTH522
CTH522 TO24 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.	Biological	Cohort A 85 mcg CTH522-CAF01, Cohort B 85 mcg CTH522-CAF01 + TO CTH522, Cohort C 85 mcg CTH522-CAF01 + ID CTH522, Cohort D 15 mcg CTH522-CAF01, Cohort E 85 mcg CTH522-CAF09b
Placebo (Saline)Placebo only given as IM, ID and TO.	Biological	Cohort A 85 mcg CTH522-CAF01, Cohort B 85 mcg CTH522-CAF01 + TO CTH522, Cohort C 85 mcg CTH522-CAF01 + ID CTH522, Cohort D 15 mcg CTH522-CAF01, Cohort E 85 mcg CTH522-CAF09b, Cohort F Placebo

Primary outcome

Solicited Local Injection Site Reactions
Time frame: Visit 2 (Day 0) plus 14 Days
Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Solicited Local Injection Site Reactions
Time frame: Visit 4 (Day 28) plus 14 Days
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.
Solicited Local Injection Site Reactions
Time frame: Visit 7 (Day 112) plus 14 Days
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.
Solicited Local Ocular Reactions
Time frame: Visit 4 (Day 28) plus 14 Days
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.
Solicited Local Ocular Reactions
Time frame: Visit 7 (Day 112) plus 14 Days
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.
Solicited Local Ocular Reactions
Time frame: Visit 9 (Day 140) plus 14 Days
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.
Solicited Systemic Reactions
Time frame: Visit 2 (Day 0) plus 14 Days
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash.
Solicited Systemic Reactions
Time frame: Visit 4 (Day 28) plus 14 Days
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash.
Solicited Systemic Reactions
Time frame: Visit 7 (Day 112) plus 14 Days
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash.

2 secondary outcomes

Immunogenicity (4-fold Increase From Baseline)
Time frame: Day 14, 28, 42, 56, 112, 126, 140, 154, 238
Immunogenicity (10-fold Increase From Baseline)
Time frame: Day 14, 28, 42, 56, 112, 126, 140, 154, 238

Results and safety

Results posted to the registry on 22 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo	2	2
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522	9	8
Cohort B1 85 mcg IM CTH522-CAF01+ TO CTH522 + TO Placebo	3	2
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522	9	9
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo	3	3
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522	9	8
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo	3	2
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522	9	9
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo	3	3
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522	9	8
Cohort F1 IM Placebo + TO Placebo	3	3
Cohort F2 IM Placebo + ID Placebo + TO Placebo	3	3

Primary outcome: Solicited Local Injection Site Reactions

Time frame: Visit 2 (Day 0) plus 14 Days. Count of participants. Unit: Participants

Measure	Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo n = 2	Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 n = 9	Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo n = 3	Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 n = 9	Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo n = 3	Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 n = 9	Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo n = 3	Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 n = 9	Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo n = 3	Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 n = 9	Cohort F2 IM Placebo + ID Placebo + TO Placebo n = 3
Injection site pain	2	8	3	9	2	9	3	9	3	9	1
Injection site warmth	0	1	2	3	1	4	0	2	1	2	1
Injection site swelling	0	1	0	0	0	1	1	0	0	3	0
Injection site erythema	0	1	0	0	0	1	0	0	1	1	0
Injection site pruritus	0	0	0	0	2	1	0	0	0	1	0

Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo vs Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 vs Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo vs Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 vs Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo vs Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 vs Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo vs Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522: p = 1, Fisher Exact
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo vs Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 vs Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo vs Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 vs Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo vs Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 vs Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo vs Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522: p = 1, Fisher Exact
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo vs Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 vs Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo vs Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 vs Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo vs Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 vs Cohort F1 IM Placebo + TO Placebo vs Cohort F2 IM Placebo + ID Placebo + TO Placebo: p = 0.0007, Fisher Exact

Primary outcome: Solicited Local Injection Site Reactions

Time frame: Visit 4 (Day 28) plus 14 Days. Count of participants. Unit: Participants

Measure	Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo n = 2	Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 n = 9	Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo n = 2	Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 n = 9	Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo n = 3	Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 n = 9	Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo n = 3	Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 n = 9	Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo n = 3	Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 n = 9	Cohort F1 IM Placebo + TO Placebo n = 3	Cohort F2 IM Placebo + ID Placebo + TO Placebo n = 3
Injection site pain	2	8	2	9	3	9	2	9	3	6	1	2
Injection site warmth	0	3	1	3	0	2	0	2	0	1	1	1
Injection site erythema	0	0	0	0	3	4	0	0	0	2	0	1
Injection site pruritus	0	0	0	0	1	2	0	2	0	1	0	0
Injection site swelling	0	0	0	0	2	0	0	0	0	3	0	1

Primary outcome: Solicited Local Injection Site Reactions

Time frame: Visit 7 (Day 112) plus 14 Days. Count of participants. Unit: Participants

Measure	Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo n = 2	Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 n = 8	Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo n = 2	Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 n = 9	Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo n = 3	Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 n = 9	Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo n = 2	Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 n = 9	Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo n = 3	Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 n = 8	Cohort F1 IM Placebo + TO Placebo n = 3	Cohort F2 IM Placebo + ID Placebo + TO Placebo n = 3
Injection site pain	1	6	2	8	2	8	1	7	2	8	2	0
Injection site erythema	0	0	0	2	3	6	0	1	1	3	1	0
Injection site warmth	0	2	1	1	1	5	0	2	0	3	1	1
Injection site swelling	0	1	1	0	2	3	1	1	0	3	0	0
Injection site pruritus	0	1	0	2	1	3	0	0	0	1	0	0

Primary outcome: Solicited Local Ocular Reactions

Time frame: Visit 4 (Day 28) plus 14 Days. Count of participants. Unit: Participants

Measure	Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 n = 9	Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 n = 9	Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo n = 3	Cohort F1 IM Placebo + TO Placebo n = 3	Cohort F2 IM Placebo + ID Placebo + TO Placebo n = 3
Ocular discomfort	1	1	1	1	1
Lacrimation increased	0	1	1	1	0
Ocular hyperaemia	0	1	1	0	0
Swelling of eyelid	0	0	1	0	0

Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 vs Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo vs Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522: p = 1, Fisher Exact
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo vs Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 vs Cohort F1 IM Placebo + TO Placebo: p = 0.3956, Fisher Exact

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 238 days after first vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Cohort F1 IM Placebo + TO Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort F2 IM Placebo + ID Placebo + TO Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Limitations and caveats (from the sponsor): Screening and recruitment activities had to be paused during the trial due to the Covid-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38615673Pollock 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alvaro Borges, MD study director

Statens Serum Institut

Katrina Pollock, MD principal investigator

Imperial Clinical Research Facility Hammersmith Hospital

Lina S Stoey, MPH study chair

Statens Serum Institut

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CTH522-CAF01 IM, CTH522-CAF09b IM and CTH522 ID in people with Trachoma, run by Statens Serum Institut at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited Local Injection Site Reactions (time frame: Visit 2 (Day 0) plus 14 Days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.