Safety and Immunogenicity of a Chlamydia Vaccine CTH522

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Brief Title

Safety and Immunogenicity of a Chlamydia Vaccine CTH522

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

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.
    

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).
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Local injection reactions

Secondary Outcome

 Secondary - immunogenicity

Condition

Trachoma

Intervention

CTH522-CAF01 IM

Study Arms / Comparison Groups

 Cohort A - 85µg CTH522-CAF01
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

66

Start Date

February 17, 2020

Completion Date

March 2022

Primary Completion Date

January 2022

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 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
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Alvaro Borges, MD, +4532683193, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03926728

Organization ID

CHLM-02


Responsible Party

Sponsor

Study Sponsor

Statens Serum Institut

Collaborators

 Imperial College London

Study Sponsor

Alvaro Borges, MD, Study Director, Statens Serum Institut


Verification Date

March 2021