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

Statens Serum Institut

Status and phase: Completed; Phase 1

Conditions: Chlamydia Trachomatis

Treatments: Biological: Placebo; Biological: CTH522-Al(OH)3; Biological: CTH522-CAF01

Study type: Interventional

Funder types: Other

Identifiers

NCT02787109

CHLM-01

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Is a healthy female between 18 and 45 years of age on the day of first trial vaccination

2. Has provided signed informed consent

3. Is willing and likely to comply with the trial procedures

4. Is prepared to grant authorised persons access to their medical record

5. 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

1. Has confirmed history of Pelvic Inflammatory Disease or significant gynaecological diseases
2. Is positive for C. trachomatis (PCR)
3. Is positive for gonorrhoea (urine), HIV, Hepatitis B/C, syphilis (blood)
4. Has a positive pregnancy test
5. Has a significant active disease - such as cardiac, liver, immunological, neurological, psychiatric; or clinically significant abnormality of haematological or biochemical parameters.
6. Has BMI of 35 kg/m2 or greater
7. Is currently participating in another clinical trial with an investigational or noninvestigational drug or device
8. 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
9. 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.)
10. Is using an intrauterine device
11. Has a condition which in the opinion of the investigator is not suitable for participation in the trial
12. Known or confirmed allergy to any of the vaccine constituents -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups, including a placebo group

CTH522-CAF01

Experimental group

Description:

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

Treatment:

Biological: CTH522-CAF01

CTH522-Al(OH)3

Experimental group

Description:

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

Treatment:

Biological: CTH522-Al(OH)3

Placebo

Placebo Comparator group

Description:

Saline for IM and In administrations

Treatment:

Biological: Placebo