> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-recombinant-rsv-vaccine-cho-ebf83138-b388-43b8-8145-a24d104cb248
> Record changed: 2026-10-13

# Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

NCT06642558

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

Phase

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

Participants

522

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

Lead sponsor

MAXVAX Biotechnology Limited Liability Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

Start date

2024-11-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Short title**

Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Official title**

A Phase I/II, Single Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Phase**

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Dates

**Completion date**

2027-02-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**First posted**

2024-10-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Registry last updated**

2025-06-06

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Primary completion date**

2025-06-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Start date**

2024-11-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Size and sites

**Participants**

522

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Planned participants**

522

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Randomisation ratio**

2:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Lead sponsor**

MAXVAX Biotechnology Limited Liability Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Identifiers

**Registry ID**

NCT06642558

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**ClinicalTrials.gov ID**

NCT06642558

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Outcomes

### Primary outcomes

1. Incidence, Intensity and Causality of adverse events(AE)  
Timeframe: Within 30 days after vaccination  
An AE includes any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not related to the investigational product.
2. Incidence, Intensity and Causality of solicited AEs  
Timeframe: Within 14 days after vaccination  
Solicited AEs include solicited local and general symptoms; Assessed solicited local AEs at injection site are pain, erythema, swelling, induration and itching; Assessed solicited general symptoms include fever, fatigue, headache, myalgia, nausea, vomiting, diarrhea, arthralgia and hypersensitivity.
3. Incidence, Intensity and Causality of unsolicited AEs  
Timeframe: Within 30 days after vaccination  
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
4. Incidence, Intensity and Causality of Severe adverse events(SAEs)  
Timeframe: Within 30 days after vaccination  
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability/incapacity or are congenital anomaly/birth defect.
5. Incidence, Intensity and Causality of Adverse events of special interest(AESI)  
Timeframe: Within 30 days after vaccination  
Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.
6. Incidence of abnormal and clinically significant laboratory test results - only for phase 1  
Timeframe: The 3rd day after vaccination  
Laboratory test includes hematology, blood biochemistry, coagulation test, urine analysis and Electrocardiograph.
7. Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A  
Timeframe: 30 days after vaccination  
Measured by Virus Neutralization Test.
8. GMT of Neutralizing Antibody against RSV-serotype B  
Timeframe: 30 days after vaccination  
Measured by Virus Neutralization Test.
9. Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A  
Timeframe: 30 days after vaccination  
Compared with the baseline Titer(Day 0).
10. GMFR of Neutralizing Antibody against RSV-serotype B  
Timeframe: 30 days after vaccination  
Compared with the baseline Titer(Day 0).
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  
Measured by ELISA.
12. GMC of RSV-PreF specific IgG Antibody against RSV-serotype B  
Timeframe: 30 days after vaccination  
Measured by ELISA.
13. GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A  
Timeframe: 30 days after vaccination  
Compared with the baseline concentration(Day 0).
14. GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B  
Timeframe: 30 days after vaccination  
Compared with the baseline concentration(Day 0).

### Secondary outcomes

1. Incidence, Intensity and Causality of SAEs  
Timeframe: Up to 12 months post vaccination  
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability/incapacity or are congenital anomaly/birth defect.
2. Incidence, Intensity and Causality of AESI  
Timeframe: Up to 12 months post vaccination  
Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.
3. GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: 14 days post vaccination-only for phase 1  
Measured by Virus Neutralization Test.
4. GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: 14 days post vaccination-only for phase 1  
Compared with the baseline Titer(Day 0).
5. GMC of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: 14 days post vaccination-only for phase 1  
Measured by ELISA.
6. GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: 14 days post vaccination-only for phase 1  
Compared with the baseline concentration(Day 0).
7. GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: At 6, 12, and 24 months post vaccination  
Measured by Virus Neutralization Test.
8. GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: At 6, 12, and 24 months post vaccination  
Compared with the baseline Titer(Day 0).
9. GMC of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: At 6, 12, and 24 months post vaccination  
Measured by ELISA.
10. GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B  
Timeframe: At 6, 12, and 24 months post vaccination  
Compared with the baseline concentration(Day 0).
11. The Frequency of RSV-PreF Specific Cluster of Differentiation 4+ (CD4+) T Cells or Cluster of Differentiation 8+ (CD8+) T cells Expressing at Least 2 Markers - only for phase 2  
Timeframe: 30 days post vaccination  
Among markers expressed were interleukin-2 (IL-2), cluster of 40 ligand (CD40L), tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSV-PreF peptide preparations.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

Yes

### Inclusion criteria

1. 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;
2. Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and signed an informed consent;
3. Be able to participate in all scheduled visits and comply with the protocol requirements;
4. 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;
5. Subjects with stable conditions considered by the investigator.

### Exclusion criteria

1. Axillary temperature>37.0℃;
2. History of RSV infection within 6 months before enrollment;
3. 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;
4. Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
5. 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;
6. Pregnant (urine pregnancy test was positive) or lactating female, or planned pregnancy within 12 months after vaccination;
7. Any confirmed or suspected immunosuppressive or immunodeficient condition due to diseases or immunosuppressive therapy, based on medical history and physical examination;
8. 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;
9. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study;
10. History of thrombocytopenia or other coagulation disorders;
11. History of convulsions, epilepsy, congenital brain dysplasia, mental illness or family history, or history of brain nerve tissue damage due to other severe neurological disorders(e.g. brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, chemical drug poisoning);
12. History of cognitive dysfunction, or any moderate or severe cognitive impairment;
13. Asplenia or functional asplenia, or autoimmune thyroid diseases, such as Hashimoto thyroiditis, toxic diffuse goiter;
14. Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
15. Previous vaccination with an RSV vaccine;
16. Administration of long-acting immune-modifying drugs(e.g. Infliximab) or planned administration at any time during the study period;
17. Administration of immunoglobulins and/or any blood products during the period starting 3 months before vaccination or planned administration during the study period;
18. Chronic administration of immunosuppressants or other immune-modifying drugs (such as long-term use of systemic glucocorticoid ≥14 days, ≥20mg/day prednisone or equivalent dose) during the period starting 3 months before vaccination or planned administration during the study period, but topical steroids(e.g. ointment, eye drops, inhalants, nasal sprays) that do not exceed the dosage recommended in the instructions or have any systemic signs are acceptable;
19. History of alcohol or drug abuse;
20. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product;
21. Planned move to a location that will prohibit participating in the trial until study end;
22. At screening: Any laboratory test results(hematology, clinical chemistry, coagulation function, or urinalysis) abnormal and clinically significant in the judgment of the investigator (Only for phase 1);
23. At screening: Any electrocardiogram abnormal and clinically significant in the judgment of the investigator (Only for phase 1);
24. Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Sites

- Liangyuan District Center for Disease Prevention and ControlShangqiu, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06642558)

## Related records

### Drugs (1)

- [Regramostim](https://trialight.com/data/asset/regramostim-71097184-8048-4d6e-a5cc-194c86388a4e.md)

### Collaborators (1)

- Henan Center for Disease Control and Prevention

### Lead sponsors (1)

- [MAXVAX Biotechnology Limited Liability Company](https://trialight.com/data/company/maxvax-biotechnology-limited-liability-company-e57374a8-4393-4abe-9d15-ea4174498f1b.md)

### Targets (1)

- [CSF3R](https://trialight.com/data/target/csf3r-7b84eab7-d92f-5a62-9246-8b76c06b0b44.md)

---

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