Safety and Immunogenicity of the Recombinant Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 18 Years and Older

NCT06904222 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: LYB005/CT-CHN-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study in China will evaluate the safety and immunogenicity of the the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in adults aged 18 years and older.

Conditions

Respiratory Syncytial Virus Infection

Keywords

Respiratory Syncytial Virus; Acute Respiratory Infection; Lower Respiratory Track Disease

Outcome Measures

Primary Outcomes (5)

• Occurrence of immediate adverse events

  The incidence and severity of any adverse events (AEs) within 30 minutes after vaccination

  Within 30 minutes after vaccination

• Incidence of solicited AE

  Occurrence and severity of solicited local injection site reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., pain, redness, swelling). Occurrence and severity of solicited systemic reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., myalgia, fatigue, headache, chills, fever).

  Within 0-7 days after vaccination

• Incidence of unsolicited AEs

  The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Days 0\~28 after the vaccination.

  Within 28 days after vaccination

• Incidence of clinically significant abnormalities in clinical laboratory tests

  The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, coagulation function, and urinalysis) on Day 3 after vaccination.

  3 days after vaccination

• Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)

  The incidence of any SAEs and AESIs from the first vaccination up to 12 months after vaccination.

  12 months after vaccination

Secondary Outcomes (4)

• The geometric mean titer (GMT) of Neutralizing Antibodies Against RSV A and RSV B

  14 days, 28 days, 3 months, 6 months and 12 months after vaccination

• Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B

  14 days, 28 days, 3 months, 6 months and 12 months after vaccination

• The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies

  14 days, 28 days, 3 months, 6 months and 12 months after vaccination

• Number of Pre-fusion Protein Specific Interferon-gamma and Interleukin-4 spot-forming cells

  28 days after vaccination

Study Arms (7)

Low dose antigen of LYB005 without A01B adjuvant

EXPERIMENTAL

Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen without A01B adjuvant) at Day 0.

Biological: Low dose antigen of LYB005 without A01B adjuvant

Low dose antigen of LYB005 with A01B adjuvant

EXPERIMENTAL

Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen with A01B adjuvant) at Day 0.

Biological: Low dose antigen of LYB005 with A01B adjuvant

Middle dose antigen of LYB005 without A01B adjuvant

EXPERIMENTAL

Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen without A01B adjuvant) at Day 0.

Biological: Middle dose antigen of LYB005 without A01B adjuvant

Middle dose antigen of LYB005 with A01B adjuvant

EXPERIMENTAL

Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen with A01B adjuvant) at Day 0.

Biological: Middle dose antigen of LYB005 with A01B adjuvant

High dose antigen of LYB005 without A01B adjuvant

EXPERIMENTAL

Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen without A01B adjuvant) at Day 0.

Biological: High dose antigen of LYB005 without A01B adjuvant

High dose antigen of LYB005 with A01B adjuvant

EXPERIMENTAL

Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen with A01B adjuvant) at Day 0.

Biological: High dose antigen of LYB005 with A01B adjuvant

Placebo

PLACEBO COMPARATOR

Subjects aged 18 years and older will be vaccinated with 1 dose of placebo at Day 0.

Biological: Placebo

Interventions

Low dose antigen of LYB005 without A01B adjuvant BIOLOGICAL

0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.

Low dose antigen of LYB005 without A01B adjuvant

Low dose antigen of LYB005 with A01B adjuvant BIOLOGICAL

0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.

Low dose antigen of LYB005 with A01B adjuvant

Middle dose antigen of LYB005 without A01B adjuvant BIOLOGICAL

0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.

Middle dose antigen of LYB005 without A01B adjuvant

Middle dose antigen of LYB005 with A01B adjuvant BIOLOGICAL

0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.

Middle dose antigen of LYB005 with A01B adjuvant

High dose antigen of LYB005 without A01B adjuvant BIOLOGICAL

0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.

High dose antigen of LYB005 without A01B adjuvant

High dose antigen of LYB005 with A01B adjuvant BIOLOGICAL

0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.

High dose antigen of LYB005 with A01B adjuvant

Placebo BIOLOGICAL

0.5 mL 0.9% sodium chloride (normal saline) injection per dose

Placebo

Eligibility Criteria

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

You may qualify if:

• Residents aged 18 years and older (at the time of screening), regardless of gender;
• Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form, and are able to attend all planned follow-up visits and comply with the protocol requirements;
• Axillary temperature \< 37.3°C on the day of enrollment;
• Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential (excluding those who have undergone tubal ligation, bilateral oophorectomy, or hysterectomy) and male participants should practice effective contraception and avoid pregnancy plans, as well as sperm or egg donation plans from the time of enrollment until 6 months after the full course of vaccination. Effective contraceptive methods include oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.

You may not qualify if:

• Allergy to the investigational vaccine or its excipients, or a history of anaphylactic shock or other serious adverse reactions to other vaccines;
• Previous vaccination against Respiratory Syncytial Virus;
• A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment;
• Has taken antipyretics, analgesics or anti-allergy drugs within 24 hours before enrollment;
• Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
• Has received blood or blood-related products, including immunoglobulin, within 3 months prior to enrollment; or plan to use them during the study period;
• Individual with the following diseases:
• Has acute diseases or are in the acute exacerbation period of chronic diseases within 3 days before vaccination;
• Diagnosed with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
• History of congenital or acquired immunodeficiency or autoimmune diseases;
• Chronic administration (≥14 consecutive days) of corticosteroids (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (\<14 consecutive days) of oral corticosteroids;
• Neurological diseases or family history (seizures, epilepsy, encephalopathy, etc.); history of psychiatric disorders or family history;
• Asplenia or functional asplenia;
• Severe or uncontrolled or hospitalization-required cardiovascular diseases, diabetes, blood and lymphatic system diseases, immune system diseases, liver and kidney diseases, respiratory system diseases, metabolic and skeletal system diseases, or malignant tumors;
• Contraindications for intramuscular injection and blood drawing, such as coagulation disorders, thrombosis or hemorrhagic diseases, or situations requiring continuous use of anticoagulants;

Sponsors & Collaborators

• Guangzhou Patronus Biotech Co., Ltd.: lead

Study Sites (1)

Dangyang City Center for Disease Control and Prevention

Dangyang, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Beifang Yang

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will be enrolled in one of six cohorts, including Cohort 1 (18-59 years, low dose, n=15), Cohort 2 (18-59 years, middle dose, n=15), Cohort 3 (≥60 years, low dose, n=15), Cohort 4 (18-59 years, high dose, n=15), Cohort 5 (≥60 years, middle dose, n=15), and Cohort 6 (≥60 years, high dose, n=15). In each cohort, five sentinels were set up, and they were randomly vaccinated with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo in a 2:2:1 ratio. The remaining participants were randomly vaccinated in a 2:2:1 ratio with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo. For both sentinels and remaining participants, the investigational vaccine group and the control group (placebo) are enrolled parallelly.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 1, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)