Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

Study Overview
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Brief Summary
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The present trial is a phase I first in human, double blind, parallel and placebo controlled trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in the United Kingdom. Subjects are randomly assigned to one of the following three treatment groups in a ratio of 3:3:1. This trial consisted of 10 visits and 5 telephonic interviews

Official Title
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A Phase I First in Human, Double-blind, Parallel, Randomised and Placebo Controlled Clinical Trial of the Safety of SSI's Adjuvanted Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

Conditions
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Chlamydia Trachomatis

Intervention / Treatment
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* Biological: CTH522-CAF01
* Biological: CTH522-Al(OH)3
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a healthy female between 18 and 45 years of age on the day of first trial vaccination Has provided signed informed consent Is willing and likely to comply with the trial procedures Is prepared to grant authorised persons access to their medical record Willing to use acceptable contraceptive measures* during the trial (2 weeks before and 2 weeks after the trial) Heterosexually active female capable of becoming pregnant must (in addition to requiring male partner to use condoms) agree to use hormonal contraception, or to complete abstinence, from at least 2 weeks before the first vaccination until at least 2 weeks after the last. (Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal and intrauterine device or intrauterine hormone releasing system 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: Has confirmed history of Pelvic Inflammatory Disease or significant gynaecological diseases Is positive for C. trachomatis (PCR) Is positive for gonorrhoea (urine), HIV, Hepatitis B/C, syphilis (blood) Has a positive pregnancy test Has a significant active disease - such as cardiac, liver, immunological, neurological, psychiatric; or clinically significant abnormality of haematological or biochemical parameters. Has BMI of 35 kg/m2 or greater Is currently participating in another clinical trial with an investigational or noninvestigational drug or device Has received, or plans to receive, an active immunisation within 14 days of the start of the trial or any of the immunisation visits in this trial Is currently receiving treatment with immunosuppressive agents e.g. oral, inhaled, nasal or injected corticosteroids. (Topical steroids are allowed, unless applied to the IM injection site.) Is using an intrauterine device Has a condition which in the opinion of the investigator is not suitable for participation in the trial Known or confirmed allergy to any of the vaccine constituents -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTH522-CAF01<br>CTH522-CAF01: CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration (preferably the non-dominant arm) CTH522 chlamydia antigen diluted with Tris buffer for IN administration | Biological: CTH522-CAF01<br>* CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration<br>|
| Experimental: CTH522-Al(OH)3<br>CTH522-Al(OH)3: CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration (preferably the non-dominant arm) CTH522 chlamydia antigen diluted with Tris buffer for IN administration | Biological: CTH522-Al(OH)3<br>* CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration<br>|
| Placebo Comparator: Placebo<br>Saline for IM and In administrations | Biological: Placebo<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine | Solicited local injection site reactions (recorded at any visit) after intramuscular (IM) administration (pain, erythema, tenderness, pruritus, warmth, stiffness and swelling) Solicited local reactions (recorded at any visit) after IN administration (discharge, including bleeding, congestion, discomfort, sneezing and cough) Solicited systemic reactions (recorded at any visit) after IM and IN administration (abnormally raised temperature, chills, myalgia, malaise, fatigue, rash, headache, nausea and vomiting, and clinically significant abnormal values among full blood count, liver function test and renal profile results) | Through study completion (Day 0 to Day 168) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum immunoglobulin G antibody responses after vaccination with CTH522 | Percentage of subjects achieving seroconversion for anti-CTH522 immunoglobulin G antibody at any time points after IM vaccination(s) | At Days 0, 28, 112, 126, 140, 154 and 168 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Immunogenicity, Phase I