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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1308-7349 | Other Identifier | WHO ICTRP |
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The purpose of this study is to evaluate the safety, efficacy, and immunogenicity of different dose levels (low, medium, and high) of Chlamydia messenger ribonucleic acid (mRNA) Vaccine candidate in adult participants aged 18 to 29 years.
This study will consist of 3 Sentinel Cohorts and a Main Cohort, with the Sentinel Cohorts assessing the safety of the different dose levels in a stepwise manner.
All participants will be followed up to 12 months after the last study intervention administration. Thus, the expected duration of the participant's involvement will be 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Cohort A Group 1: Chlamydia trachomatis Seronegative | Experimental | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
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| Sentinel Cohort B Group 2: Chlamydia trachomatis Seronegative | Experimental | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
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| Sentinel Cohort C Group 3: Chlamydia trachomatis Seronegative | Experimental | Participants will receive three high dose injections of Chlamydia mRNA Vaccine |
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| Sentinel Cohort A, B and C Group 4: Chlamydia trachomatis Seronegative | Placebo Comparator | Participants will receive three injections of Placebo |
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| Sentinel Cohort A Group 5: Chlamydia trachomatis Seropositive | Experimental | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlamydia mRNA Vaccine | Biological | Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of immediate unsolicited systemic adverse events (AEs) | Number of participants with immediate unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccine injection. | Within 30 minutes after each vaccine injection |
| Presence of solicited injection site and systemic reactions | Number of participants with solicited injection site and systemic reactions occurring up to 7 days after each vaccine injection. | Up to 7 days after each vaccine injection |
| Presence of unsolicited AEs | Participants with unsolicited AEs reported up to 28 days after each vaccine injection. | Up to 28 days after each vaccine injection. |
| Presence of medically attended adverse events (MAAEs) | Number of participants with MAAEs reported after each vaccine injection and up to 6 months after last vaccine injection. | Up to 6 months after last vaccine injection |
| Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs) | Number of participants with SAEs and all AESIs reported after each vaccine injection and up to 12 months after last vaccine injection | Up to 12 months after last vaccine injections |
| Presence of related SAEs, and fatal SAEs | Number of participants with related SAEs, and fatal SAEs throughout the study | Throughout the study, appriximatley 18 months |
| Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of serum binding antibodies to specific Chlamydia trachomatis antigens and whole bacteria in immunogenicity subset | Binding Immunoglobulin (Ig) will be measured using a multiplex electrochemiluminescent (ECL) based binding assay | Before each vaccine injection through 1 month after each vaccine injection |
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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:
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.
Exclusion Criteria:
Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 0360002 | Recruiting | Bruce | Australian Capital Territory | 2617 | Australia | |
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| Label | URL |
|---|---|
| VAV00023 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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Sequential (Phase 1) / parallel (Phase 2), dose finding, multi center
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Sentinel Cohorts: modified double-blind
| Sentinel Cohort B Group 6: Chlamydia trachomatis Seropositive | Experimental | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
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| Sentinel Cohort C Group 7: Chlamydia trachomatis Seropositive | Experimental | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
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| Sentinel Cohort A, B and C Group 8: Chlamydia trachomatis Seropositive | Placebo Comparator | Participants will receive three injections of Placebo |
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| Main Cohort Group 9: Chlamydia trachomatis Seronegative | Experimental | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
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| Main Cohort Group 10: Chlamydia trachomatis Seronegative | Experimental | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
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| Main Cohort Group 11: Chlamydia trachomatis Seronegative | Experimental | Participants will receive three high dose injections of Chlamydia mRNA Vaccine |
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| Main Cohort Group 12: Chlamydia trachomatis Seronegative | Placebo Comparator | Participants will receive three injections of Placebo |
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| Main Cohort Group 13: Chlamydia trachomatis Seropositive | Experimental | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
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| Main Cohort Group 14: Chlamydia trachomatis Seropositive | Experimental | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
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| Main Cohort Group 15: Chlamydia trachomatis Seropositive | Experimental | Participants will receive three high dose injections of Chlamydia mRNA Vaccine |
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| Main Cohort Group 16: Chlamydia trachomatis Seropositive | Placebo Comparator | Participants will receive three injections of Placebo |
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| Placebo | Other | Pharmaceutical Form: Solution for injection Route of Administration: Intramuscular injection |
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Number of participants with out-of-range biological test results up to 7 days after each vaccine injection |
| Up to 7 days after each vaccination injections |
| 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 |
Geometric mean cell-mediated immune responses will be measured by an intracellular cytokine staining assay over time |
| Before each vaccine injection through 1 month after each vaccine injection |
| Investigational Site Number : 0360006 |
| Recruiting |
| Maroubra |
| New South Wales |
| 2035 |
| Australia |
| Investigational Site Number : 0360005 | Recruiting | Sydney | New South Wales | 2010 | Australia |
| Investigational Site Number : 0360001 | Recruiting | Albion | Queensland | 4010 | Australia |
| Investigational Site Number : 0360004 | Recruiting | Morayfield | Queensland | 4506 | Australia |
| Investigational Site Number : 0360003 | Recruiting | Southport | Queensland | 4222 | Australia |
| Investigational Site Number : 0360010 | Recruiting | Melbourne | Victoria | 3000 | Australia |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |