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