Clinical trial NCT02787109: Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chlamydia Trachomatis
Keywords: Safety
Immunogenicity
Phase I
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2016-06-01
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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 -

Primary outcomes:
measure: Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine
timeFrame: Through study completion (Day 0 to Day 168)
Secondary outcomes:
measure: Serum immunoglobulin G antibody responses after vaccination with CTH522
timeFrame: At Days 0, 28, 112, 126, 140, 154 and 168
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital
Study officials:
affiliation: Imperial College London
name: Sonya Abraham
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abraham S, Juel HB, Bang P, Cheeseman HM, Dohn RB, Cole T, Kristiansen MP, Korsholm KS, Lewis D, Olsen AW, McFarlane LR, Day S, Knudsen S, Moen K, Ruhwald M, Kromann I, Andersen P, Shattock RJ, Follmann F. Safety and immunogenicity of the chlamydia vaccine candidate CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2019 Oct;19(10):1091-1100. doi: 10.1016/S1473-3099(19)30279-8. Epub 2019 Aug 12.