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

NCT02787109 | Completed Phase 1 DMC

• 1 other identifier: CHLM-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Chlamydia Trachomatis

Keywords

Safety; Immunogenicity; Phase I

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum immunoglobulin G antibody responses after vaccination with CTH522

  At Days 0, 28, 112, 126, 140, 154 and 168

Study Arms (3)

CTH522-CAF01

EXPERIMENTAL

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

CTH522-Al(OH)3

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Saline for IM and In administrations

Biological: Placebo

Interventions

CTH522-CAF01 BIOLOGICAL

CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration

CTH522-CAF01

CTH522-Al(OH)3 BIOLOGICAL

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

CTH522-Al(OH)3

Placebo BIOLOGICAL

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Statens Serum Institut: lead
• Imperial College London: collaborator

Study Sites (1)

NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31416692 DERIVED

Study Officials

• Sonya Abraham

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: July 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)