Chlamydia Trachomatis Immunization
Conditions
Keywords
Chlamydia
Brief summary
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.
Interventions
BIOLOGICALChlamydia mRNA Vaccine
Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular injection
OTHERPlacebo
Pharmaceutical Form: Solution for injection Route of Administration: Intramuscular injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Sentinel Cohorts: modified double-blind * Investigator, participants, and laboratory personnel will be blinded * Clinical site staff preparing / administering the study vaccines will be unblinded * Sponsor study staff involved in the early safety data review (ESDR) will be unblinded at the time of the ESDR Main Cohort: modified double-blind * Investigator, participants, laboratory personnel, and Sponsor study staff will be blinded * Only clinical site staff preparing / administering the study vaccines will be unblinded
Intervention model description
Sequential (Phase 1) / parallel (Phase 2), dose finding, multi center
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of immediate unsolicited systemic adverse events (AEs) | Within 30 minutes after each vaccine injection | Number of participants with immediate unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccine injection. |
| Presence of solicited injection site and systemic reactions | Up to 7 days after each vaccine injection | Number of participants with solicited injection site and systemic reactions occurring up to 7 days after each vaccine injection. |
| Presence of unsolicited AEs | Up to 28 days after each vaccine injection. | Participants with unsolicited AEs reported up to 28 days after each vaccine injection. |
| Presence of medically attended adverse events (MAAEs) | Up to 6 months after last vaccine injection | Number of participants with MAAEs reported after each vaccine injection and up to 6 months after last vaccine injection. |
| Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs) | Up to 12 months after last vaccine injections | Number of participants with SAEs and all AESIs reported after each vaccine injection and up to 12 months after last vaccine injection |
| Presence of related SAEs, and fatal SAEs | Throughout the study, appriximatley 18 months | Number of participants with related SAEs, and fatal SAEs throughout the study |
| Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort) | Up to 7 days after each vaccination injections | Number of participants with out-of-range biological test results up to 7 days after each vaccine injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of serum binding antibodies to specific Chlamydia trachomatis antigens and whole bacteria in immunogenicity subset | Before each vaccine injection through 1 month after each vaccine injection | Binding Immunoglobulin (Ig) will be measured using a multiplex electrochemiluminescent (ECL) based binding assay |
| 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 | Before each vaccine injection through 1 month after each vaccine injection | Geometric mean cell-mediated immune responses will be measured by an intracellular cytokine staining assay over time |
Countries
Australia
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed