Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged... | NCT02787109

NCT02787109

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Imperial College London	OTHER

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CTH522-CAF01	Biological	CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration	CTH522-CAF01

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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 -

Name	Affiliation	Role
Sonya Abraham	Imperial College London	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital		London		W12 0HS	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31416692	Derived	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.