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.
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.
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.
Single group
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
Biological/Vaccine0.5 mL per dose
Neutralizing Antibodies against both the RSV-A and RSV-B subtypes.
Measured by Virus Neutralization Test.
Specific IgG Antibodies to RSV pre-F of both RSV-A and RSV-B subtypes.
Measured by ELISA.
The Frequency of RSV pre-F Specific Cluster of Differentiation 4+ (CD4+) T Cells or Cluster of Differentiation 8+ (CD8+) T cells Expressing.
Among markers expressed were interleukin-2 (IL-2), cluster of 40 ligand (CD40L), tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSV-PreF peptide preparations. Measured by Intracellular Cytokine Staining (ICS).
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MAXVAX Biotechnology Limited Liability Company
Lead sponsor
Henan Center for Disease Control and Prevention
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
