The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.
A total of 522 subjects in the phase 1/2 study will be enrolled. The study will be conducted in 2 parts (phase 1 for dose escalation and phase 2 for expansion), with first evaluation of safety of 2 two dose levels of Recombinant RSV vaccine(CHO cells) in healthy participants aged 18-59 and ≥60 in phase 1 before preceding with vaccination of the participants aged 50-59 and ≥60 in phase 2. To ensure the safety of the study participants, phase 1 will follow a staggered enrolment with 3 steps. All subjects in each age group in phase 1 will be randomly receive the investigational vaccine(half or full dose) and the placebo in a 2:1 ratio, while all subjects in each age group in phase 2 will be randomly receive the half dose vaccine, the full dose vaccine and the placebo in a 1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
522
Liangyuan District Center for Disease Prevention and Control
Shangqiu, Henan, China
Incidence, Intensity and Causality of adverse events(AE)
An AE includes any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not related to the investigational product.
Time frame: Within 30 days after vaccination
Incidence, Intensity and Causality of solicited AEs
Solicited AEs include solicited local and general symptoms; Assessed solicited local AEs at injection site are pain, erythema, swelling, induration and itching; Assessed solicited general symptoms include fever, fatigue, headache, myalgia, nausea, vomiting, diarrhea, arthralgia and hypersensitivity.
Time frame: Within 14 days after vaccination
Incidence, Intensity and Causality of unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 30 days after vaccination
Incidence, Intensity and Causality of Severe adverse events(SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability/incapacity or are congenital anomaly/birth defect.
Time frame: Within 30 days after vaccination
Incidence, Intensity and Causality of Adverse events of special interest(AESI)
Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.
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Time frame: Within 30 days after vaccination
Incidence of abnormal and clinically significant laboratory test results - only for phase 1
Laboratory test includes hematology, blood biochemistry, coagulation test, urine analysis and Electrocardiograph.
Time frame: The 3rd day after vaccination
Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A
Measured by Virus Neutralization Test.
Time frame: 30 days after vaccination
GMT of Neutralizing Antibody against RSV-serotype B
Measured by Virus Neutralization Test.
Time frame: 30 days after vaccination
Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A
Compared with the baseline Titer(Day 0).
Time frame: 30 days after vaccination
GMFR of Neutralizing Antibody against RSV-serotype B
Compared with the baseline Titer(Day 0).
Time frame: 30 days after vaccination
Geometric Mean Concentration (GMC) of RSV-Prefusion F protein(RSV-PreF) specific Immunoglobulin G (IgG) Antibody against RSV-serotype A
Measured by ELISA.
Time frame: 30 days after vaccination
GMC of RSV-PreF specific IgG Antibody against RSV-serotype B
Measured by ELISA.
Time frame: 30 days after vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A
Compared with the baseline concentration(Day 0).
Time frame: 30 days after vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B
Compared with the baseline concentration(Day 0).
Time frame: 30 days after vaccination
Incidence, Intensity and Causality of SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability/incapacity or are congenital anomaly/birth defect.
Time frame: Up to 12 months post vaccination
Incidence, Intensity and Causality of AESI
Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.
Time frame: Up to 12 months post vaccination
GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Measured by Virus Neutralization Test.
Time frame: 14 days post vaccination-only for phase 1
GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline Titer(Day 0).
Time frame: 14 days post vaccination-only for phase 1
GMC of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Measured by ELISA.
Time frame: 14 days post vaccination-only for phase 1
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline concentration(Day 0).
Time frame: 14 days post vaccination-only for phase 1
GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Measured by Virus Neutralization Test.
Time frame: At 6, 12, and 24 months post vaccination
GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline Titer(Day 0).
Time frame: At 6, 12, and 24 months post vaccination
GMC of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Measured by ELISA.
Time frame: At 6, 12, and 24 months post vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline concentration(Day 0).
Time frame: At 6, 12, and 24 months post vaccination
The Frequency of RSV-PreF Specific Cluster of Differentiation 4+ (CD4+) T Cells or Cluster of Differentiation 8+ (CD8+) T cells Expressing at Least 2 Markers - only for phase 2
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.
Time frame: 30 days post vaccination