Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.

NCT07582796 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: aRSV-ZHSW-01
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus; Safety; RSV vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (10)

• Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination.

  Within 14 days post-vaccination.

• Incidence of unsolicited AEs within 30 days post-vaccination.

  Within 30 days post-vaccination.

• 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

  On Days 3, 14, and 30 post-vaccination

• Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post-vaccination.

  Within 12 months post-vaccination.

• At 1 month post-vaccination: geometric mean titer (GMT) of neutralizing antibodies against RSV-A and RSV-B.

  Applicable to Phase Ⅱ only

  At 1 month post-vaccination

• At 1 month post-vaccination: seroresponse rate (SRR) of neutralizing antibodies against RSV-A and RSV-B.

  Applicable to Phase Ⅱ only

  At 1 month post-vaccination

• At 1 month post-vaccination: geometric mean fold rise (GMFR) of neutralizing antibodies against RSV-A and RSV-B.

  Applicable to Phase Ⅱ only

  At 1 month post-vaccination

• At 1 month post-vaccination: geometric mean concentration (GMC) of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.

  Applicable to Phase Ⅱ only

  At 1 month post-vaccination

• At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.

  Applicable to Phase Ⅱ only

  At 1 month post-vaccination

• At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.

  Applicable to Phase Ⅱ only

  At 1 month post-vaccination

Secondary Outcomes (13)

• At 1 month post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.

  At 1 month post-vaccination

• At 1 month post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.

  At 1 month post-vaccination

• At 1 month post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.

  At 1 month post-vaccination

• At 1 month post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.

  At 1 month post-vaccination

• At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.

  At 1 month post-vaccination

Study Arms (7)

Investigational Vaccine 1 (Low Dose) Group

EXPERIMENTAL

Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted)

Investigational Vaccine 2 (Low Dose) Group

EXPERIMENTAL

Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)

Investigational Vaccine 1 Group

EXPERIMENTAL

Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted)

Investigational Vaccine 2 Group

EXPERIMENTAL

Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)

Investigational Vaccine 3 Group

EXPERIMENTAL

Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant)

Adjuvant Control Group

PLACEBO COMPARATOR

Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant)

Placebo Group

PLACEBO COMPARATOR

Biological: Normal Saline

Interventions

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted) BIOLOGICAL

The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

Investigational Vaccine 1 (Low Dose) Group

Normal Saline BIOLOGICAL

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

Placebo Group

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant) BIOLOGICAL

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

Investigational Vaccine 3 Group

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant) BIOLOGICAL

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

Adjuvant Control Group

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted) BIOLOGICAL

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

Investigational Vaccine 1 Group

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) BIOLOGICAL

The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

Investigational Vaccine 2 (Low Dose) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Women of childbearing potential: Defined as females who have experienced menarche and have not yet entered menopause, unless permanently sterile, such as documented bilateral salpingectomy, bilateral oophorectomy, or hysterectomy; menopause is defined as amenorrhea for 12 consecutive months without other medical cause.
• \[Effective contraceptive measures include: oral contraceptives, injectable contraceptives, subdermal implants or hormonal patches, intrauterine device (IUD), sterilization surgery, abstinence (no sexual intercourse), male condoms, etc.; rhythm method, withdrawal, and emergency contraception are not considered effective contraceptive measures.\]
• Axillary body temperature ≤ 37.0°C measured on site prior to vaccination on the day of vaccination.

You may not qualify if:

• 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.
• Treatment with immunomodulators (including immunosuppressants and immunostimulants) within 6 months prior to vaccination (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent) (excluding inhaled, intra-articular, and topical steroids).
• Administration or planned use of long-acting immunomodulatory drugs (e.g., infliximab) at any time during the study.
• A history of severe allergic reactions (e.g., anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, Arthus reaction) following any previous vaccination or drug use, or a family history of severe allergies.
• Impaired immune function or a diagnosis of congenital or acquired immunodeficiency, or human immunodeficiency virus (HIV) infection.
• A personal or family history of convulsions, epilepsy, encephalopathy, psychiatric disorders, or neurological diseases (such as Guillain-Barré syndrome, Miller Fisher syndrome).
• A diagnosis of lymphoproliferative disease or malignant tumor within 5 years.
• Clinically significant electrocardiogram (ECG) abnormalities as determined by the investigator (applicable only to the phase I part).
• Previous vaccination with any licensed or investigational RSV vaccine prior to enrollment, or planned vaccination during the study.
• Receipt of any vaccine within 14 days prior to vaccination, or any live vaccine within 30 days prior to vaccination.
• An acute disease or an acute exacerbation of a chronic disease within 3 days prior to vaccination, or use of antipyretic, analgesic, or anti-allergy medications.
• Suspected or known alcohol abuse or alcohol dependence (referring to a drinking pattern that causes serious mental or physical health problems) or drug abuse.

Sponsors & Collaborators

• Ab&B Bio-tech Co., Ltd.JS: lead
• Yither Biotech Co., Ltd: collaborator

Study Sites (1)

Zigong Center for Disease Control and Prevention

Zigong, Sichuan, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Adjuvants, Pharmaceutic; Saline Solution

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Ting Huang, Bachelor

  Sichuan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Zhao, Master

CONTACT

18168168075; zhaoxue@abbbio.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): September 14, 2027
• Study Completion (Estimated): August 14, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)