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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06891417




Registration number
NCT06891417
Ethics application status
Date submitted
17/03/2025
Date registered
25/03/2025

Titles & IDs
Public title
Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
Scientific title
A Phase 1/2, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Immunogenicity, and Efficacy of a Chlamydia Trachomatis mRNA Vaccine Candidate in Adults Aged 18 to 29 Years
Secondary ID [1] 0 0
U1111-1308-7349
Secondary ID [2] 0 0
VAV00023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chlamydia Trachomatis Immunization 0 0
Condition category
Condition code
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Chlamydia mRNA Vaccine
Other interventions - Placebo

Experimental: Sentinel Cohort A Group 1: Chlamydia trachomatis Seronegative - Participants will receive three low dose injections of Chlamydia mRNA Vaccine

Experimental: Sentinel Cohort B Group 2: Chlamydia trachomatis Seronegative - Participants will receive three medium dose injections of Chlamydia mRNA Vaccine

Experimental: Sentinel Cohort C Group 3: Chlamydia trachomatis Seronegative - Participants will receive three high dose injections of Chlamydia mRNA Vaccine

Placebo comparator: Sentinel Cohort A, B and C Group 4: Chlamydia trachomatis Seronegative - Participants will receive three injections of Placebo

Experimental: Sentinel Cohort A Group 5: Chlamydia trachomatis Seropositive - Participants will receive three low dose injections of Chlamydia mRNA Vaccine

Experimental: Sentinel Cohort B Group 6: Chlamydia trachomatis Seropositive - Participants will receive three medium dose injections of Chlamydia mRNA Vaccine

Experimental: Sentinel Cohort C Group 7: Chlamydia trachomatis Seropositive - Participants will receive three medium dose injections of Chlamydia mRNA Vaccine

Placebo comparator: Sentinel Cohort A, B and C Group 8: Chlamydia trachomatis Seropositive - Participants will receive three injections of Placebo

Experimental: Main Cohort Group 9: Chlamydia trachomatis Seronegative - Participants will receive three low dose injections of Chlamydia mRNA Vaccine

Experimental: Main Cohort Group 10: Chlamydia trachomatis Seronegative - Participants will receive three medium dose injections of Chlamydia mRNA Vaccine

Experimental: Main Cohort Group 11: Chlamydia trachomatis Seronegative - Participants will receive three high dose injections of Chlamydia mRNA Vaccine

Placebo comparator: Main Cohort Group 12: Chlamydia trachomatis Seronegative - Participants will receive three injections of Placebo

Experimental: Main Cohort Group 13: Chlamydia trachomatis Seropositive - Participants will receive three low dose injections of Chlamydia mRNA Vaccine

Experimental: Main Cohort Group 14: Chlamydia trachomatis Seropositive - Participants will receive three medium dose injections of Chlamydia mRNA Vaccine

Experimental: Main Cohort Group 15: Chlamydia trachomatis Seropositive - Participants will receive three high dose injections of Chlamydia mRNA Vaccine

Placebo comparator: Main Cohort Group 16: Chlamydia trachomatis Seropositive - Participants will receive three injections of Placebo


Treatment: Other: Chlamydia mRNA Vaccine
Pharmaceutical Form: Suspension for injection

Route of Administration:

Intramuscular injection

Other interventions: Placebo
Pharmaceutical Form:

Solution for injection

Route of Administration:

Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of immediate unsolicited systemic adverse events (AEs)
Timepoint [1] 0 0
Within 30 minutes after each vaccine injection
Primary outcome [2] 0 0
Presence of solicited injection site and systemic reactions
Timepoint [2] 0 0
Up to 7 days after each vaccine injection
Primary outcome [3] 0 0
Presence of unsolicited AEs
Timepoint [3] 0 0
Up to 28 days after each vaccine injection.
Primary outcome [4] 0 0
Presence of medically attended adverse events (MAAEs)
Timepoint [4] 0 0
Up to 6 months after last vaccine injection
Primary outcome [5] 0 0
Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs)
Timepoint [5] 0 0
Up to 12 months after last vaccine injections
Primary outcome [6] 0 0
Presence of related SAEs, and fatal SAEs
Timepoint [6] 0 0
Throughout the study, appriximatley 18 months
Primary outcome [7] 0 0
Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort)
Timepoint [7] 0 0
Up to 7 days after each vaccination injections
Secondary outcome [1] 0 0
Assessment of serum binding antibodies to specific Chlamydia trachomatis antigens and whole bacteria in immunogenicity subset
Timepoint [1] 0 0
Before each vaccine injection through 1 month after each vaccine injection
Secondary outcome [2] 0 0
Geometric mean cell-mediated immune response of antigen-specific T helper type 1 (Th1) and T helper type 2 (Th2) cytokine-producing T cells by phenotype
Timepoint [2] 0 0
Before each vaccine injection through 1 month after each vaccine injection

Eligibility
Key inclusion criteria
* Aged 18 to 29 years on the day of inclusion
* New sex partner within the past 6 months, or more than one current sex partner, or partner with known previous or coexisting sexually transmitted infection (STI), or inconsistent condom use
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be surgically sterile.

OR

• Is of childbearing potential and agrees to use an effective contraceptive method from at least 4 weeks prior to study intervention administration until at least 4 weeks after the last study intervention administration.

* A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) at the screening visit and before each subsequent study intervention administration
Minimum age
18 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any screening laboratory parameter with laboratory abnormalities as per local reference range and that are greater than Grade 2 or deemed clinically significant in the opinion of the Investigator
* Participants who are Chlamydia trachomatis (CT) and/or Neisseria gonorrhea (NG) NAAT positive at screening visit
* Self-reported or documented seropositivity for HIV antigen and/or antibodies (Abs), hepatitis B virus surface antigen (HBsAg), hepatitis B core antibodies (HBcAbs), or hepatitis C virus (HCV) Abs infection at screening visit
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s) used in the study or to a product containing any of the same substances
* Previous history of myocarditis, pericarditis, and/or myopericarditis
* Known history of previous history of Guillain-Barre syndrome and other immune mediated demyelinating conditions that include but are not limited to Multiple Sclerosis (MS), Neuromyelitis Optica (NMO), acute disseminated encephalomyelitis (ADEM), Transverse myelitis
* Screening electrocardiogram (ECG) value that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or screening ECG that demonstrates clinically relevant abnormalities, per investigator, that may affect participant safety or study results
* Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Moderate or severe acute febrile illness (temperature = 38.0°C [= 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
* Receipt of any mRNA vaccine/product in the 2 months preceding study enrollment or planned receipt of any mRNA vaccine/product within the 2 months following any study intervention administration
* Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration, except influenza which may be received at least 2 weeks before or 2 weeks after any study vaccination
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/01/2028
Actual
Sample size
Target
1560
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Albion
Recruitment postcode(s) [1] 0 0
4010 - Albion

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06891417