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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 29
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Australia
Investigational Site Number : 0360001
RECRUITING
Albion
Investigational Site Number : 0360002
RECRUITING
Bruce
Investigational Site Number : 0360006
RECRUITING
Maroubra
Investigational Site Number : 0360010
RECRUITING
Melbourne
Investigational Site Number : 0360004
RECRUITING
Morayfield
Investigational Site Number : 0360003
RECRUITING
Southport
Investigational Site Number : 0360005
RECRUITING
Sydney
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date:2025-03-27
Estimated Completion Date:2028-01-03
Participants
Target number of participants:1560
Treatments
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