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A Phase 2 Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants

ConditionHerpes Zoster
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-79
SponsorShenzhen Shenxin Biotechnology Co., Ltd

About this trial

The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of 3 dose levels of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 79 years of age.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female adults, of any race or ethnicity, between 50 and 79 years of age, inclusive, at Screening.

Male and female participants must have a body mass index between 18.5 and 34.9 kg/m², inclusive, at Screening, and body weight ≥ 50 kg for males and ≥ 45 kg for females.

Participants must be able to freely provide documented informed consent prior to study procedures being performed.

Participants must be in good general health as determined by comprehensive evaluation by Investigators at the time of enrollment.

Disqualifiers

Participants with a known history of HZ.

Participants with a known history of GBS, encephalomyelitis, or transverse myelitis.

Participants with a known history of severe heart disease (i.e., heart failure, recent coronary artery disease, myocarditis, pericarditis, or cardiomyopathy).

Participants with acute medical illness or febrile illness, including oral temperature ≥ 38.0°C (≥ 100.4°F) within 1 day prior to Screening. These individuals may be offered the opportunity to enter the study after the fever and/or acute illness has been resolved.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HZ Vaccine (IN001)

    Biological/Vaccine

    Formulation for injection

  • Shingrix

    Biological/Vaccine

    Sterile suspension for injection

Treatment groups

480 Participants
are divided into 4 treatment groups
Group A: IN001 Dose A (Arm 1)Experimental treatment 1 intervention
Group B: IN001 Dose B (Arm 2)Experimental treatment 1 intervention
Group C: IN001 Dose C (Arm 3)Experimental treatment 1 intervention
Group D: Shingrix (Arm 4)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame
Baseline (before first vaccination); 28 days post-second vaccination
2

Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA

Time frame
28 days post-second vaccination
3

Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

Time frame
Baseline (before first vaccination); 28 days post-second vaccination
4

Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

Time frame
28 days post-second vaccination

Secondary outcomes

1

GMC of Anti-gE Antibodies as Measured by ELISA

Time frame
Baseline (before first vaccination); 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
2

Change from Baseline in GMFR of Anti-gE Antibodies as Measured by ELISA

Time frame
28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
3

GMT of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

Time frame
Baseline (before first vaccination); 56 days post-first vaccination; 6 and 12 months post-second vaccination
4

Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

Time frame
56 days post-first vaccination; 6 and 12 months post-second vaccination

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: