Respiratory Syncytial VirusPhase 1/2NCT06754605
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine
A Phase 1/2 study testing SCTV02 in people with Respiratory Syncytial Virus, run by Sinocelltech Ltd. at 2 sites in China.
Trial summary
This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- SCTV02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 2 sitesChina
- Study dates
- 6 Feb 2025to 30 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the time of signing the ICF.
- Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.
- Be able to complete the diary card, contact card and diary/contact card by own or with the assistance of others.
- Phase I: healthy subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects who are healthy or have a stable underlying disease.
- Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after immunization; Pregnancy test results for women of childbearing age during the screening period were negative.
Who cannot join
- Acute illness and/or fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic, analgesic, or antiallergic drugs.
- Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.
- Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine/product at any time during the study.
- Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination.
- The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously received the experimental respiratory syncytial virus (RSV) vaccine or been infected with RSV within 1 year prior to receiving the investigational vaccine.
- History or family history of epilepsy and mental illness.
Show all 14Show fewer
- A family history of congenital or hereditary immunodeficiency, or a history and physical examination confirmed or suspected immunosuppression or immunodeficiency, or human immunodeficiency virus (HIV) infection, asplenia or functional asplenia.
- Have the following organ-specific or systemic autoimmune diseases: Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, and systemic sclerosis.
- Allergic to any component of the study vaccine, or any previous history of severe allergy to vaccine vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
- Severe chronic disease or active chronic disease, as assessed by the investigator, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, uncontrolled blood pressure after medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in subjects < 60 years of age; Hypertensive disease with systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg in subjects ≥60 years of age, diabetes mellitus with serious complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart diseases, respiratory diseases, liver and kidney diseases, and thyroid diseases.
- Pregnant women (positive pregnancy test) or breastfeeding women, or those with pregnancy plans during the study period, or less than 6 weeks after the end of pregnancy (including ectopic pregnancy).
- Plan to donate eggs or sperm during the study.
- Unable to follow the trial procedures, or plan to relocate or stay away for a long period of time during the study and cannot complete the trial follow-up.
- Any medical condition that makes intramuscular injection unsafe due to other abnormalities, conditions that may obfuscate the results of the study, or conditions that are not in the best interest of the subject, is determined by the investigator to be unsuitable for clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Hebei Zhongshiyou Central Hospital
Langfang, Hebei, 965000
Zhao Kexin, Doctor, 86-0316-2073657
- Not yet recruiting
Luzhou Center for Disease Control and Prevention
Luzhou, Sichuan, 646399
He Wenlin, Doctor, 86-0830-2584041
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults ≥18 Years of Age
This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.
Read the detailed description
Three dose-levels of SCTV02 will be evaluated in participants aged 18 years and older. Solicited adverse events within 7 days post study vaccination and unsolicited adverse events within 30 days post study vaccination will be collected. Immunogenicity including Neutralizing antibody against RSV-A and RSV-B will be tested 14, 30, 90, 180 and 365 days post study vaccination will be assessed. T cell response will be tested 30 days post study vaccination.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- SCTV02, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTV02Biological
Participants will receive a singe dose of SCTV02 on Day 0.
PlaceboBiological
Participants will receive a singe dose of Placebo on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| A: Low dose vaccine | Experimental | Low dose of SCTV02, injected on Day 0 Receives: Biological: SCTV02 |
| A: Low dose placebo | Placebo comparator | Placebo comparator of low dose, injected on Day 0 Receives: Biological: Placebo |
| B: Medium dose vaccine | Experimental | Medium dose of SCTV02, injected on Day 0 Receives: Biological: SCTV02 |
| B: Medium dose placebo | Placebo comparator | Placebo comparator of medium dose, injected on Day 0 Receives: Biological: Placebo |
| C: High dose vaccine | Experimental | High dose of SCTV02, injected on Day 0 Receives: Biological: SCTV02 |
| C: High dose placebo | Placebo comparator | Placebo comparator of high dose, injected on Day 0 Receives: Biological: Placebo |
| D: Low dose vaccine | Experimental | Low dose of SCTV02, injected on Day 0 Receives: Biological: SCTV02 |
| E: Medium dose vaccine | Experimental | Medium dose of SCTV02, injected on Day 0 Receives: Biological: SCTV02 |
| F: High dose vaccine | Experimental | High dose of SCTV02, injected on Day 0 Receives: Biological: SCTV02 |
| G: Placebo | Placebo comparator | Placebo comparator, injected on Day 0 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Measured: Day o to Day 7
Geometric mean titer (GMT) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days post vaccination
Geometric mean titer (GMT, Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days after study vaccination.
Measured: Day 30
Secondary outcomes (7)
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.Immunogenicity 14 days post vaccination
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.
Measured: Day 14
GMT of nAb against RSV-A and RSV-B subtypes 90 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 90 days after study vaccination.
Measured: Day 90
GMT of nAb against RSV-A and RSV-B subtypes 180 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 180 days after study vaccination.
Measured: Day 180
GMT of nAb against RSV-A and RSV-B subtypes 365 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 365 days after study vaccination.
Measured: Day 365
T cell response
Number of T cell subsets activated by interferon-γ (for Th1) and interleukin-4 (for Th2) 30 days after study vaccination.
Measured: Day 30
Incidence and severity of unsolicited adverse events within 30 days
Incidence and severity of unsolicited adverse events within 30 days after study vaccination.
Measured: Day to Day 30
Incidence and severity of Serious adverse events and adverse events of special interest within 365 days
Incidence and severity of Serious adverse events and adverse events of special interest within 365 days after study vaccination.
Measured: Day 0 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start6 Feb 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhao Kexin, Doctor, Principal investigator, Hebei Zhongshiyou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754605
- Sponsor's protocol ID
- SCTV02-X201
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults ≥18 Years of Age
- ClinicalTrials.gov ID
- NCT06754605
- Acronym / sponsor ID
- SCTV02-X201
- Conditions
- Respiratory Syncytial Virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.
Detailed description
Three dose-levels of SCTV02 will be evaluated in participants aged 18 years and older. Solicited adverse events within 7 days post study vaccination and unsolicited adverse events within 30 days post study vaccination will be collected. Immunogenicity including Neutralizing antibody against RSV-A and RSV-B will be tested 14, 30, 90, 180 and 365 days post study vaccination will be assessed. T cell response will be tested 30 days post study vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| A: Low dose vaccine | Experimental | Biological: SCTV02Low dose of SCTV02, injected on Day 0 |
| A: Low dose placebo | Placebo comparator | Biological: PlaceboPlacebo comparator of low dose, injected on Day 0 |
| B: Medium dose vaccine | Experimental | Biological: SCTV02Medium dose of SCTV02, injected on Day 0 |
| B: Medium dose placebo | Placebo comparator | Biological: PlaceboPlacebo comparator of medium dose, injected on Day 0 |
| C: High dose vaccine | Experimental | Biological: SCTV02High dose of SCTV02, injected on Day 0 |
| C: High dose placebo | Placebo comparator | Biological: PlaceboPlacebo comparator of high dose, injected on Day 0 |
| D: Low dose vaccine | Experimental | Biological: SCTV02Low dose of SCTV02, injected on Day 0 |
| E: Medium dose vaccine | Experimental | Biological: SCTV02Medium dose of SCTV02, injected on Day 0 |
| F: High dose vaccine | Experimental | Biological: SCTV02High dose of SCTV02, injected on Day 0 |
| G: Placebo | Placebo comparator | Biological: PlaceboPlacebo comparator, injected on Day 0 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the time of signing the ICF.
- Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.
- Be able to complete the diary card, contact card and diary/contact card by own or with the assistance of others.
- Phase I: healthy subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects who are healthy or have a stable underlying disease.
- Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after immunization; Pregnancy test results for women of childbearing age during the screening period were negative.
Key exclusion criteria (14 listed)
- Acute illness and/or fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic, analgesic, or antiallergic drugs.
- Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.
- Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine/product at any time during the study.
- Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination.
- The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously received the experimental respiratory syncytial virus (RSV) vaccine or been infected with RSV within 1 year prior to receiving the investigational vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTV02Participants will receive a singe dose of SCTV02 on Day 0. | Biological | A: Low dose vaccine, B: Medium dose vaccine, C: High dose vaccine, D: Low dose vaccine, E: Medium dose vaccine, F: High dose vaccine |
| PlaceboParticipants will receive a singe dose of Placebo on Day 0. | Biological | A: Low dose placebo, B: Medium dose placebo, C: High dose placebo, G: Placebo |
Primary outcome
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Time frame: Day o to Day 7
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Geometric mean titer (GMT) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days post vaccination
Time frame: Day 30
Geometric mean titer (GMT, Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days after study vaccination.
7 secondary outcomes
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.Immunogenicity 14 days post vaccination
Time frame: Day 14
GMT of nAb against RSV-A and RSV-B subtypes 90 days post vaccination
Time frame: Day 90
GMT of nAb against RSV-A and RSV-B subtypes 180 days post vaccination
Time frame: Day 180
GMT of nAb against RSV-A and RSV-B subtypes 365 days post vaccination
Time frame: Day 365
T cell response
Time frame: Day 30
Incidence and severity of unsolicited adverse events within 30 days
Time frame: Day to Day 30
Incidence and severity of Serious adverse events and adverse events of special interest within 365 days
Time frame: Day 0 to Day 365
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao Kexin, Doctor principal investigator
Hebei Zhongshiyou Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCTV02 in people with Respiratory Syncytial Virus, run by Sinocelltech Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Xinjie, Doctor (86+010-58628288, xinjie_yang@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of solicited adverse events within 7 days post study vaccination. (time frame: Day o to Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.