Safety and Immunogenicity of a Chlamydia Vaccine CTH522
Condition: Trachoma
MeSH terms: Chlamydia Infections; Trachoma
Study type: Interventional
Phase: Phase 1

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.
    

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).
    

Intervention name(s): CTH522-CAF01 IM; CTH522-CAF09b IM; CTH522 ID; CTH522 TO; Placebo (Saline)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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.; 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.; 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.; 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.; Placebo only given as IM, ID and TO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: CTH522; Chlamydia; C. Trachomatis