About this trial
The purpose of this study is to elucidate the molecular mechanism by which novel adjuvants enhance the immunogenicity of Respiratory Syncytial Virus (RSV) vaccines by regulating antigen-specific B cell affinity maturation and T cell memory formation.
Eligibility criteria
Qualifiers
Participants must be 20 years of age or older as determined by the investigator at enrollment.
Participants must be able to understand study procedures, risks, and benefits, provide voluntary agreement to participate in the study, and sign the informed consent form (ICF).
Participants must be willing and able to attend all scheduled follow-up visits and comply with all requirements specified in the study protocol.
Females of childbearing potential must use highly effective contraception from 1 month prior to vaccination through 12 months following vaccination.
Disqualifiers
Axillary body temperature ≥ 37.3 °C.
History of respiratory syncytial virus (RSV) infection within 6 months prior to enrollment.
New-onset respiratory infection symptoms within 7 days prior to enrollment, including cough, expectoration, dyspnea, wheezing, fever, rhinorrhea, and nasal obstruction.
Presence of an acute illness or acute exacerbation of a chronic condition within 3 days prior to enrollment.
Trial design
Treatments tested in this trial
- Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
Treatment groups
Locations
Sponsors and collaborators
MAXVAX Biotechnology Limited Liability Company
Lead sponsor
Henan Center for Disease Control and Prevention
Collaborator