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 range18 Years

SexALL

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;
✕. 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;

What they're measuring

Incidence, Intensity and Causality of adverse events(AE)

Timeframe: Within 30 days after vaccination

Incidence, Intensity and Causality of solicited AEs

Timeframe: Within 14 days after vaccination

Incidence, Intensity and Causality of unsolicited AEs

Timeframe: Within 30 days after vaccination

Incidence, Intensity and Causality of Severe adverse events(SAEs)

Timeframe: Within 30 days after vaccination

Incidence, Intensity and Causality of Adverse events of special interest(AESI)

Timeframe: Within 30 days after vaccination

Incidence of abnormal and clinically significant laboratory test results - only for phase 1

Timeframe: The 3rd day after vaccination

Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A

Timeframe: 30 days after vaccination

GMT of Neutralizing Antibody against RSV-serotype B

Trial details

NCT IDNCT06642558

SponsorMAXVAX Biotechnology Limited Liability Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Respiratory Syncytial Virus (RSV) trials

Who can participate

Age range18 Years

SexALL

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;
✕. 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;

What they're measuring

Incidence, Intensity and Causality of adverse events(AE)

Timeframe: Within 30 days after vaccination

Incidence, Intensity and Causality of solicited AEs

Timeframe: Within 14 days after vaccination

Incidence, Intensity and Causality of unsolicited AEs

Timeframe: Within 30 days after vaccination

Incidence, Intensity and Causality of Severe adverse events(SAEs)

Timeframe: Within 30 days after vaccination

Incidence, Intensity and Causality of Adverse events of special interest(AESI)

Timeframe: Within 30 days after vaccination

Incidence of abnormal and clinically significant laboratory test results - only for phase 1

Timeframe: The 3rd day after vaccination

Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A

Timeframe: 30 days after vaccination

GMT of Neutralizing Antibody against RSV-serotype B