Not Yet RecruitingPhase 2

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

480 participantsStarted 2026-05-01

Plain-language summary

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.

Who can participate

Age range50 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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/m\^2, 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.

Exclusion criteria

✕. Participants must be able and agree to comply with all study visits and procedures (including blood tests, diary completion, receipt of telephone calls from the site, willingness to be available for unscheduled clinic visits).
✕. Females of reproductive age will not be pregnant or lactating.
✕. Females of childbearing potential, who are sexually active and at risk for pregnancy with their partner(s), must have used appropriate method of contraception at least 30 days prior to enrollment and agree to use a highly effective method of contraception consistently and correctly from enrollment to Study Day 236 (6 months after second vaccination). The Investigator or designee, in consultation with the participant, will confirm that the participant has selected an appropriate method of contraception for the individual participant and his or her partner from the list of appropriate contraception methods and will confirm that the participant has been instructed in its consistent and correct use.
✕. Participants must be willing to refrain from blood donation throughout study participation.
✕. 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.

What they're measuring

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

Timeframe: Baseline (before first vaccination); 28 days post-second vaccination

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

Timeframe: 28 days post-second vaccination

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

Timeframe: Baseline (before first vaccination); 28 days post-second vaccination

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

Timeframe: 28 days post-second vaccination

Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA

Timeframe: 28 days post-second vaccination

Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

Timeframe: 28 days post-second vaccination

Percentage of Participants Reporting Solicited Local Reactions

Timeframe: For 14 days after each vaccination

Trial details

NCT IDNCT07205796

SponsorShenzhen Shenxin Biotechnology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Clinical Development Innorna

+86-755-86532375 cd@innorna.com

View on ClinicalTrials.gov More Herpes Zoster trials

Who can participate

Age range50 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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/m\^2, 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.

Exclusion criteria

✕. Participants must be able and agree to comply with all study visits and procedures (including blood tests, diary completion, receipt of telephone calls from the site, willingness to be available for unscheduled clinic visits).
✕. Females of reproductive age will not be pregnant or lactating.
✕. Females of childbearing potential, who are sexually active and at risk for pregnancy with their partner(s), must have used appropriate method of contraception at least 30 days prior to enrollment and agree to use a highly effective method of contraception consistently and correctly from enrollment to Study Day 236 (6 months after second vaccination). The Investigator or designee, in consultation with the participant, will confirm that the participant has selected an appropriate method of contraception for the individual participant and his or her partner from the list of appropriate contraception methods and will confirm that the participant has been instructed in its consistent and correct use.
✕. Participants must be willing to refrain from blood donation throughout study participation.
✕. 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.

What they're measuring

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

Timeframe: Baseline (before first vaccination); 28 days post-second vaccination

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

Timeframe: 28 days post-second vaccination

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

Timeframe: Baseline (before first vaccination); 28 days post-second vaccination

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

Timeframe: 28 days post-second vaccination

Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA

Timeframe: 28 days post-second vaccination

Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

Timeframe: 28 days post-second vaccination

Percentage of Participants Reporting Solicited Local Reactions

Timeframe: For 14 days after each vaccination