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

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

Treatments tested in this trial

  • HZ Vaccine (IN001)
  • Shingrix

Treatment groups

480 Participants
are divided into 4 treatment groups

Locations

This trial has no locations