Chlamydia TrachomatisPhase 1NCT02787109
Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
A Phase 1 study testing CTH522-CAF01 and CTH522-Al(OH)3 in people with Chlamydia Trachomatis, run by Statens Serum Institut at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis
- What is being tested?
- CTH522-CAF01 and CTH522-Al(OH)3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 31 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital
London, W12 0HS
About this study
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
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
- Being tested
- CTH522-CAF01, CTH522-Al(OH)3, Placebo
- Keywords
- Safety, Immunogenicity, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTH522-CAF01Biological
CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration
CTH522-Al(OH)3Biological
CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration
PlaceboBiological
Saline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: CTH522-Al(OH)3 |
| Placebo | Placebo comparator | Saline for IM and In administrations Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion (Day 0 to Day 168)
Secondary outcomes (1)
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)
Measured: At Days 0, 28, 112, 126, 140, 154 and 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chlamydia TrachomatisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Sonya Abraham, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787109
- Sponsor's protocol ID
- CHLM-01
- Status last verified
- Aug 2017
- First submitted
- 23 May 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Olsen AW, Rosenkrands I, Jacobsen CS, Cheeseman HM, Kristiansen MP, Dietrich J, Shattock RJ, Follmann F. Immune signature of Chlamydia vaccine CTH522/CAF(R)01 translates from mouse-to-human and induces durable protection in mice. Nat Commun. 2024 Feb 23;15(1):1665. doi: 10.1038/s41467-024-45526-2.
PubMed 38396019Abraham 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.
PubMed 31416692
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02787109
- Acronym / sponsor ID
- CHLM-01
- Conditions
- Chlamydia Trachomatis
- Keywords
- Safety, Immunogenicity, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Jul 2016
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTH522-CAF01 | Experimental | Biological: CTH522-CAF01CTH522-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 |
| CTH522-Al(OH)3 | Experimental | Biological: CTH522-Al(OH)3CTH522-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 |
| Placebo | Placebo comparator | Biological: PlaceboSaline for IM and In administrations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTH522-CAF01CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration | Biological | CTH522-CAF01 |
| CTH522-Al(OH)3CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration | Biological | CTH522-Al(OH)3 |
| PlaceboSaline | Biological | Placebo |
Primary outcome
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)
1 secondary outcome
Serum immunoglobulin G antibody responses after vaccination with CTH522
Time frame: At Days 0, 28, 112, 126, 140, 154 and 168
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Derived from this study: PubMed 38396019Olsen AW, Rosenkrands I, Jacobsen CS, Cheeseman HM, Kristiansen MP, Dietrich J, Shattock RJ, Follmann F. Immune signature of Chlamydia vaccine CTH522/CAF(R)01 translates from mouse-to-human and induces durable protection in mice. Nat Commun. 2024 Feb 23;15(1):1665. doi: 10.1038/s41467-024-45526-2.
- Derived from this study: PubMed 31416692Abraham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonya Abraham principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTH522-CAF01 and CTH522-Al(OH)3 in people with Chlamydia Trachomatis, run by Statens Serum Institut at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of adverse events/reactions and laboratory safety of adjuvanted chlamydia vaccine (time frame: Through study completion (Day 0 to Day 168)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02787109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.