Respiratory Syncytial Virus (RSV)
Conditions
Brief summary
This study will evaluate the efficacy of the Recombinant RSV vaccine(CHO cell) vaccine in preventing lower respiratory tract diseases(LRTD) caused by RSV in adults≥ 60 years of following a single dose of the RSV vaccine(CHO cell) vaccine .This study will also assess if the vaccine is safe and induces an immune response.
Detailed description
A total of 25000 adults aged 60 years and above will be enrolled, stratified into 60-69 and ≥70 years of age. All Participants will randomly receive investigational vaccine or placebo at a ratio of 1:1. Efficacy and safety will be assessed in all Participants, while immunogenicity will be assessed in a subset of 1200 Participants in a selected trial site.
Interventions
BIOLOGICALRecombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
0.5 mL per dose
BIOLOGICALPlacebo (Saline solution)
0.5 mL per dose
Sponsors
Henan Center for Disease Control and Prevention
Hunan Provincial Center for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Shaanxi Provincial Center for Disease Control and Prevention
Guangdong Center for Disease Prevention and Control
Shandong Province Centers for Disease Control and Prevention
Sichuan Center for Disease Control and Prevention
Hebei CDC ,China
MAXVAX Biotechnology Limited Liability Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. A male or female can provide legal identification at the time of enrollment, and is 60 years of age or older (women are required to be infertile). (Note: Women with infertility include those who have been menopausal or have undergone sterilization (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.) 2. Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and sign an informed consent. 3. Be able to participate in all scheduled visits and comply with the protocol requirements 4. Participants with stable health conditions considered by the investigator. Stable health conditions refer to patients with chronic diseases whose conditions are stable (regardless of whether they have received specific treatment or not), such as diabetes, hypertension, chronic obstructive pulmonary disease, asthma, etc. If the researcher determines that the condition is stable, they may be allowed to participate in this trial.
Exclusion criteria
Participants who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The first-time incidence rate per person-year of Lower Respiratory Tract Disease (LRTD). | From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months. | A case caused by RSV-A and/or RSV-B as confirmed by Reverse Transcription-Polymerase Chain Reaction（RT-PCR）. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The first-time incidence rate per person-year of Acute Respiratory Illness (ARI). | From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months. | A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR. |
| The first-time incidence rate per person-year of Severe Lower Respiratory Tract Disease (sLRTD). | From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months. | A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR. |
| The first-time incidence rate per person-year of LRTD. | After vaccination, during the second RSV epidemic season,assessed up to 12 months. | A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR. |
| The first-time incidence rate per person-year of ARI. | After vaccination, during the second RSV epidemic season,assessed up to 12 months. | A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR. |
| The first-time incidence rate per person-year of sLRTD. | After vaccination, during the second RSV epidemic season,assessed up to 12 months. | A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR. |
| Geometric Mean Titers (GMT) of Neutralizing Antibody against RSV-serotype A and RSV-serotype B. | At 14 days,1,12,24 and 36 months after vaccination | Measured by Virus Neutralization Test. |
| Incidence and Causality of Adverse event of special interest (AESI) | Up to 12 months post vaccination | Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation. |
| Geometric Mean Concentrations (GMC) of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B | At 14 days,1,12,24 and 36 months after vaccination | Measured by ELISA. |
| GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B | At 14 days,1,12,24 and 36 months after vaccination | Measured by ELISA. |
| Incidence, Intensity and Causality of adverse events(AEs) | Within 30 days after vaccination | An AE includes any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Incidence, Intensity and Causality of solicited AEs | Within 7 days after vaccination | 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. |
| Incidence, Intensity and Causality of unsolicited AEs | Within 30 days after vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation participants 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. |
| Incidence and Causality of Severe adverse events(SAEs) | Up to 12 months post vaccination | 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. |
| Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A and RSV-serotype B | At 14 days,1,12,24 and 36 months after vaccination | Measured by Virus Neutralization Test. |
Countries
China
Contacts
Primary ContactLiangHao Zhang
Outcome results
None listed