A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Va… (NCT06375512) | Clinical Trial Compass
CompletedPhase 1
A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
United States, Australia150 participantsStarted 2024-07-05
Plain-language summary
The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age
Who can participate
Age range
50 Years – 69 Years
Sex
ALL
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
. Healthy male or female participants aged between 50 to 69 years of age, inclusive.
. 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/m\^2.
Exclusion criteria
. For all women of childbearing potential (WOCBP) females must be non-pregnant and non-lactating and must use a highly effective contraceptive method from at least 30 days prior to enrollment through to 6 months after second vaccination.
. Willing to provide documented informed consent and comply with the requirements of the clinical study protocol.
. Participants with a known history of HZ.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Reporting Solicited Local Reactions
Timeframe: For 14 days after each vaccination
2
Percentage of Participants Reporting Solicited Systemic Reactions
Timeframe: For 14 days after each vaccination
3
Percentage of Participants With Unsolicited Adverse Events (AEs)
Timeframe: For 28 days after each vaccination
4
Percentage of Participants With Any Medically Attended AEs (MAAEs)
Timeframe: From initial vaccination to 6 months after the second vaccination
5
Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal
Timeframe: From initial vaccination to 12 months after the second vaccination
. Participants with a known history of GBS, encephalomyelitis, or transverse myelitis.
. Participants with a known history of heart disease (eg, 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. Participants with suspected or confirmed COVID-19 should be excluded and referred for medical care.
. Participants with any medical, neurological, or psychiatric condition that, in the opinion of the Investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
. Participants with a known history of hypersensitivity reactions including anaphylaxis and urticaria, or other significant adverse reactions to IN001 or its excipients; or participants with a known history of severe allergic reaction (eg, anaphylaxis) to any component of SHINGRIX™ or after a previous dose of SHINGRIX™.