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Completed

NCT Number: NCT02787109

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

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

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Key information

Conditions

Chlamydia Trachomatis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital

London, W12 0HS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

CTH522-CAF01

Biological

CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration

CTH522-Al(OH)3

Biological

CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration

Placebo

Biological

Saline

Primary outcomes

  1. Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine

    Time frame: Through study completion (Day 0 to Day 168)

    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)

Secondary outcomes

  1. Serum immunoglobulin G antibody responses after vaccination with CTH522

    Time frame: At Days 0, 28, 112, 126, 140, 154 and 168

    Percentage of subjects achieving seroconversion for anti-CTH522 immunoglobulin G antibody at any time points after IM vaccination(s)

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Collaborators

  • Imperial College London

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2016
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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