Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAb&B Bio-tech Co., Ltd.JS
About this trial
The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females aged 18 years and older at the time of enrollment (aged 18 years and older for the phase I part; aged 60 years and older for the phase II part), who are able to provide legal proof of identity.
Voluntarily agree to participate in the trial, able to fully understand and sign the informed consent form.
Able to attend all scheduled follow-up visits and comply with the requirements of the clinical trial protocol to complete the study.
Female participants must meet the following criteria: In the phase I part, women of childbearing potential* must have a negative pregnancy test prior to enrollment and be willing to use effective contraceptive measures for 12 months after receiving the investigational vaccine; in the phase II part, only women of non-childbearing potential will be enrolled.
Disqualifiers
Clinically significant laboratory abnormalities that, in the investigator's comprehensive judgment, preclude enrollment (applicable only to the phase I part).
Pregnant or breastfeeding women.
A clear diagnosis of RSV infection or a history of RSV infection-related respiratory disease within 6 months prior to vaccination.
Use of immunoglobulins or/and any blood products or plasma derivatives within 3 months prior to vaccination, or planned use during the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted)
Biological/VaccineThe vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)
Biological/VaccineThe vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant)
Biological/VaccineThe vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted)
Biological/VaccineThe vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)
Biological/VaccineThe vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Normal Saline
Biological/VaccineThe vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant)
Biological/VaccineThe vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Treatment groups
470 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Investigational Vaccine 1 (Low Dose) GroupExperimental treatment 1 intervention
Group B: Investigational Vaccine 2 (Low Dose) GroupExperimental treatment 1 intervention
Group C: Investigational Vaccine 1 GroupExperimental treatment 1 intervention
Group D: Investigational Vaccine 2 GroupExperimental treatment 1 intervention
Group E: Investigational Vaccine 3 GroupExperimental treatment 1 intervention
Group F: Adjuvant Control GroupPlacebo comparator 1 intervention
Group G: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination.
Time frame
Within 14 days post-vaccination.2
Incidence of unsolicited AEs within 30 days post-vaccination.
Time frame
Within 30 days post-vaccination.3
Incidence of clinically significant laboratory abnormalities(blood biochemistry, blood routine, coagulation function, urinalysis) on Day 3 post-vaccination, and incidence of clinically significant ECG abnormalities on Days 3, 14, and 30 post-vaccination.
Applicable to Phase I only
Time frame
On Days 3, 14, and 30 post-vaccination4
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post-vaccination.
Time frame
Within 12 months post-vaccination.Secondary outcomes
1
At 1 month post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Time frame
At 1 month post-vaccination2
At 1 month post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Time frame
At 1 month post-vaccination3
At 1 month post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Time frame
At 1 month post-vaccination4
At 1 month post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase I only
Time frame
At 1 month post-vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ab&B Bio-tech Co., Ltd.JS
Lead sponsor
Yither Biotech Co., Ltd
Collaborator
Source ClinicalTrials.gov