Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years… (NCT06642558) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above
China522 participantsStarted 2024-11-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A male or female, in the opinion of the investigator, aged 18 and older for phase 1 and aged 50 and older for phase 2 at the time of the enrollment;
. Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and signed an informed consent;
. Be able to participate in all scheduled visits and comply with the protocol requirements;
. Women of childbearing potential are willing to use effective contraception (e.g. oral contraceptives, injectable progestogen, implants of levonorgestrel, percutaneous contraceptive patches, intrauterine device (IUD), female and male sterilization, abstinence, condoms, or diaphragms), and the rhythm method, withdrawal and emergency contraception pills are not acceptable;
. Subjects with stable conditions considered by the investigator.
Exclusion criteria
. Axillary temperature\>37.0℃;
. History of RSV infection within 6 months before enrollment;
. New onset of respiratory tract infection symptoms like cough, sputum, shortness of breath, wheezing, fever, runny nose or nasal congestion within 7 days before enrollment;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, Intensity and Causality of adverse events(AE)
Timeframe: Within 30 days after vaccination
2
Incidence, Intensity and Causality of solicited AEs
Timeframe: Within 14 days after vaccination
3
Incidence, Intensity and Causality of unsolicited AEs
Timeframe: Within 30 days after vaccination
4
Incidence, Intensity and Causality of Severe adverse events(SAEs)
Timeframe: Within 30 days after vaccination
5
Incidence, Intensity and Causality of Adverse events of special interest(AESI)
Timeframe: Within 30 days after vaccination
6
Incidence of abnormal and clinically significant laboratory test results - only for phase 1
Timeframe: The 3rd day after vaccination
7
Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A
Timeframe: 30 days after vaccination
Trial details
NCT IDNCT06642558
SponsorMAXVAX Biotechnology Limited Liability Company
. Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
. A known allergy to any components of the study vaccine, or history of severe allergy (e.g. anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, severe urticaria) or serious adverse reactions to any previous vaccination or drug use;
. Pregnant (urine pregnancy test was positive) or lactating female, or planned pregnancy within 12 months after vaccination;
. Any confirmed or suspected immunosuppressive or immunodeficient condition due to diseases or immunosuppressive therapy, based on medical history and physical examination;
. Serious or unstable chronic illness, including but not limit to cardiovascular diseases (such as uncontrolled hypertension, coronary heart disease, myocarditis, pericarditis), metabolic diseases (such as poorly controlled diabetes), hematological diseases (such as severe anemia, hemophilia), liver and kidney diseases, digestive diseases, respiratory diseases (such as chronic obstructive pulmonary disease, active tuberculosis, other severe respiratory diseases ), malignant tumor, major functional organ transplantation history;
8
GMT of Neutralizing Antibody against RSV-serotype B
Timeframe: 30 days after vaccination
9
Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A
Timeframe: 30 days after vaccination
10
GMFR of Neutralizing Antibody against RSV-serotype B
Timeframe: 30 days after vaccination
11
Geometric Mean Concentration (GMC) of RSV-Prefusion F protein(RSV-PreF) specific Immunoglobulin G (IgG) Antibody against RSV-serotype A
Timeframe: 30 days after vaccination
12
GMC of RSV-PreF specific IgG Antibody against RSV-serotype B
Timeframe: 30 days after vaccination
13
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A
Timeframe: 30 days after vaccination
14
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B