Health TrialsbyHealthPanel

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults

ConditionRespiratory Syncytial Virus Infections
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-79
SponsorShenzhen Shenxin Biotechnology Co., Ltd

About this trial

The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female participants aged ≥18 to 59 years of age (Part 1) or ≥ 60 to 79 years of age (Part 2).

Body weight ≥ 50 kg for males and ≥ 45 kg for females and body mass index (BMI) in the range of 18.5 to 35 kg/m².

For all women of childbearing potential (WOCBP) females must be non-pregnant and non-lactating and must use an appropriate contraceptive method from at least 30 days prior to study vaccination (an effective contraception) until at least 6 months after study vaccination. Women not of childbearing potential must be postmenopausal for ≥ 12 months.

Male participants who are non-sterilized and sexually active must be willing to use an acceptable, effective contraceptive method from at least 30 days prior to study vaccination until at least 6 months after study vaccination.

Disqualifiers

Pregnant or lactating at Screening or prior to vaccination or planning to become pregnant (self or partner) at any time during the study, including the specified Follow-up period.

Participants with a known (documented or self-reported) history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.

Participants with a known (documented or self-reported) history of heart disease (eg, heart failure, recent coronary artery disease, myocarditis, pericarditis, cardiomyopathy, or atrial fibrillation). Note: chronic stable coronary artery disease that is considered mild may be allowed at the discretion of the Investigator.

Participants with uncontrolled hypertension (supine systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at Screening). Results at Screening may be confirmed by single repeat at the discretion of the Investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bivalent RSV Vaccine (IN006)

    Biological/Vaccine

    Formulation for injection

  • Placebo

    Biological/Vaccine

    0.9% sodium chloride (normal saline) injection

Treatment groups

200 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Cohort 1: Dose A in Younger AdultsExperimental treatment 2 interventions
Group B: Cohort 2: Dose B in Younger AdultsExperimental treatment 2 interventions
Group C: Cohort 3: Dose C in Younger AdultsExperimental treatment 2 interventions
Group D: Cohort 4: Dose D in Younger AdultsExperimental treatment 2 interventions
Group E: Cohort 5: Dose B in Older AdultsExperimental treatment 2 interventions
Group F: Cohort 6: Dose C in Older AdultsExperimental treatment 2 interventions
Group G: Cohort 7: Dose D in Older AdultsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination

Time frame
From initial vaccination up to14 days post initial vaccination
2

Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination

Time frame
From initial vaccination up to 28 days post initial vaccination
3

Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation Through 12 Months After Initial Vaccination

Time frame
From initial vaccination up to 12 months post initial vaccination
4

Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination

Time frame
From initial vaccination up to 6 months post initial vaccination

Secondary outcomes

1

Geometric Mean Titer (GMT) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay)

Time frame
Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged 60 to 79 years)
2

Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay)

Time frame
Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged 60 to 79 years)
3

Vaccine Response Rate for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay)

Time frame
Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged 60 to 79 years)
4

GMC for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA])

Time frame
Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged 60 to 79 years)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Shenxin Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: