Phase 1 N=65 Randomized Quadruple-blind Prevention

Safety and Immunogenicity of a Chlamydia Vaccine CTH522

Trachoma

Bottom Line

View on ClinicalTrials.gov: NCT03926728 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Solicited Local Injection Site Reactions — 2; 8; 3; 9 Participants — p=1

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: CTH522-CAF01 IM (Biological); CTH522-CAF09b IM (Biological); CTH522 ID (Biological); CTH522 TO (Biological); Placebo (Saline) (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Statens Serum Institut
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Solicited Local Injection Site Reactions	1; 6; 2; 8; 2; 8	—
PRIMARY Solicited Local Injection Site Reactions	1; 6; 2; 8; 2; 8	—
PRIMARY Solicited Local Injection Site Reactions	1; 6; 2; 8; 2; 8	—
PRIMARY Solicited Local Ocular Reactions	0; 2; 0; 3; 0; 1	—
PRIMARY Solicited Local Ocular Reactions	0; 2; 0; 3; 0; 1	—
PRIMARY Solicited Local Ocular Reactions	0; 2; 0; 3; 0; 1	—
PRIMARY Solicited Systemic Reactions	0; 1; 0; 1; 1; 2	—
PRIMARY Solicited Systemic Reactions	0; 1; 0; 1; 1; 2	—
PRIMARY Solicited Systemic Reactions	0; 1; 0; 1; 1; 2	—
SECONDARY Immunogenicity (4-fold Increase From Baseline)	0; 6; 2; 7; 2; 7	—
SECONDARY Immunogenicity (10-fold Increase From Baseline)	0; 5; 1; 5; 2; 3	—

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.

Eligibility 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 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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03926728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.