Respiratory Syncytial Virus (RSV)
Conditions
Keywords
RSV vaccine, Acute Respiratory Infection, Lower Respiratory Track Disease
Brief summary
This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older
Detailed description
This is a single-center, randomized, blinded, placebo-controlled trial. A total of 128 trial participants aged 18 years and older will be enrolled: 64 trial participants aged 18-59 years and 64 trial participants aged 60 years and older. Each age stratum will be divided into four cohorts, for a total of eight cohorts: low-dose antigen cohorts, high-dose antigen cohorts , adjuvant-only cohorts, and low-dose antigen + adjuvant cohorts in the 18-59-year and 60-years-and-older strata. Eligible trial participants in each cohort will be randomized 3:1 on Day 0 to receive one dose of investigational vaccine (low-dose antigen, high-dose antigen, adjuvant, or low-dose antigen + adjuvant) or placebo. Enrollment will proceed in the order of adults (18-59 years) to older adults (60 years and older), low dose to high dose, and antigen to adjuvant to antigen + adjuvant. To ensure the safety of the study population, the first four trial participants enrolled in each cohort will be designated as sentinel trial participants and randomized 3:1 to investigational vaccine or placebo.
Interventions
BIOLOGICALRecombinant RSV Vaccine (CHO Cell)
0.4 mL per dose
BIOLOGICALAdjuvant Suspension
0.9 mL per dose
BIOLOGICALRecombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension
0.9 mL per dose
BIOLOGICALSaline solution
0.9 mL per dose
Sponsors
Yikang Biotech (Suzhou) Co., Ltd.
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults aged 18 years and older who reside in the local area and can provide legal proof of identity; sex is not restricted; 2. Trial participants understand the informed consent form and the vaccine to be administered, voluntarily agree to participate and sign the informed consent form, and are able to use a thermometer and ruler and complete the diary card and contact card as required. If a participant is unable to sign the informed consent form independently because of limited literacy, the informed consent process and signature may be completed with the assistance of an impartial witness; 3. Able to communicate effectively with the investigator and understand and comply with all trial requirements; 4. Women of childbearing potential (see Appendix 2 for the definition) must have used effective contraception for 2 weeks before enrollment, have a negative urine pregnancy test before investigational vaccine administration (women not of childbearing potential are exempt), and voluntarily agree to continue using at least one effective contraceptive method for 6 months after vaccination. Effective contraception includes oral contraceptives, injectable or implantable contraception, long-acting local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, male condoms, diaphragms, cervical caps, etc. Male trial participants must agree to use effective contraception with female partners of reproductive potential from the screening visit until 6 months after immunization.
Exclusion criteria
Trial participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of immediate adverse events | Within 30 minutes after vaccination | Incidence of all adverse events within 30 minutes after vaccination |
| Incidence of solicited AEs | Within 0-14 days after vaccination | Incidence of solicited (local and systemic) adverse events within 14 days after vaccination |
| Incidence of unsolicited AEs | Within 30 days after vaccination | Incidence of unsolicited adverse events within 30 days after vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically significant abnormalities in clinical laboratory tests | 4 days after vaccination | Incidence of clinically significant abnormal laboratory test results on Day 4 after vaccination |
| Incidence of clinically significant abnormal findings on 12-lead electrocardiograms | 4 days, 14 days, 30 days after vaccination | Incidence of clinically significant abnormal findings on 12-lead electrocardiograms on Days 4, 14, and 30 after vaccination |
| Occurrence of serious adverse events (SAEs) | Within 24 months after vaccination | Occurrence of serious adverse events (SAEs) within 24 months after vaccination |
| Occurrence of adverse events of special interest (AESIs) | Within 12 months after vaccination | Occurrence of adverse events of special interest (AESIs) within 12 months after vaccination |
| GMT of Neutralizing Antibody against RSV serotype A and B | 30 days after vaccination | Measured by plaque reduction neutralization test (PRNT) |
| GMFR of Neutralizing Antibody against RSV serotype A and B | 30 days after vaccination | Measured by plaque reduction neutralization test (PRNT) |
| SCR of Neutralizing Antibody against RSV serotype A and B | 30 days after vaccination | Measured by plaque reduction neutralization test (PRNT) |
| GMC of pre-F protein-binding antibodies | 30 days after vaccination | Measured by enzyme-linked immunosorbent assay(ELISA) |
| GMFR of pre-F protein-binding antibodies | 30 days after vaccination | Measured by enzyme-linked immunosorbent assay(ELISA) |
| SCR of pre-F protein-binding antibodies | 30 days after vaccination | Measured by enzyme-linked immunosorbent assay(ELISA) |
| The frequencies of antigen-specific T cells secreting IL-2 and IFN-γ | 14 days, 30 days after vaccination | Measured by ELISpot assay |
| The frequencies of antigen-specific CD4+ and CD8+ T cells expressing IL-2 and IFN-γ | 14 days, 30 days after vaccination. | Measured by ICS assay |
Countries
China
Contacts
CONTACTXuqin Yang, Master
Outcome results
None listed