Upstate Active Clinical Trials
Study Title:
A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of AgeWhat is the purpose of the study? (in Layman's terms, please describe the study)
The purpose of this Phase 3 study is to evaluate this vaccine efficacy against primary cytomegalovirus (CMV) infection in healthy CMV -seronegative women 16-40 years of age, and to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1647 in CMV -seronegative and CMV -seropositive participants.Upstate Institutional Review Board (IRB) Number:
1997938Study/Protocol ID:
mRNA-1647-P301Study Phase:
Phase IIIPatient Age Group:
Adults and ChildrenPrincipal Investigator:
Joseph B DomachowskeWho is eligible?
- Is a female and 16-40 years of age, at time of consent.- According to the assessment of the Investigator, is capable of complying with study procedures.
- For female participants aged > 20 years, has or anticipates having direct exposure within 7 months after the planned first dose (in the home, socially, or occupationally) to at least 1 child < 5 years of age. Direct exposure is defined as either a) participant is the parent, or b) participant has close contact (feeding, diaper changes, childcare/supervision)) for at least 8 hours a week.
- For the CMV-seronegative cohorts: at the screening visit, is CMV IgG-negative and CMV IgM-negative.
- For the CMV-seropositive Cohorts: at the screening visit, is CMV IgG-positive and CMV IgM-negative, or CMV IgG-Positive and CMV IgM-positive. Participants with an isolated positive result for CMV IgM (ie, CMV IgG-negative and CMV IgM- positive) will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV Screening. A participant with a CMV IgG-positive result and an IgM-indeterminate result at Screening will not require the IgM sampling to be repeated in order to consider the participant seropositive.
- Participant (and parent/LAR, if applicable) provides written informed consent/assent. Participants under age of majority (i.e., under legal age) at the time of of enrollment must provide written informed consent at the next study visit once turning the age of majority.
- Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/LAR(s), as applicable, understands and is willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30-month study period.
- Female participants of childbearing potential: urine pregnancy test is negative at screening and negative on the day of the first injection (day 1). Note: urine pregnancy test at screening or day 1 is not required for female participants of nonchildbearing potential.
- Female participants of childbearing potential: if the participant is sexually active with men, all of the following criteria must be met. a) has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1). b) Agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257). Adequate contraception is defined as consistent ands correct use of an approved contraceptive method in accordance with the product label, or sterilization of a monogamous male partner prior to study enrollment.
What is involved if I participate?
- How long is the study?
30 months - Is transportation provided or reimbursed?
Yes - Is parking provided or reimbursed?
Yes - What tests and procedures are involved?
a blood test and urine test will be performed at each in person visit
Where will the study take place?
Crouse Physicians Office Building725 Irving Ave. Suite 401
Syracuse, NY 13210
Other Information:
N/AWho can I contact for more information?
Name: Nishat Anwar, MD,MPH
Phone: 315-464-7505
Email: [email protected]