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 range50 Years – 69 Years
SexALL
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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.
✕. 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.
✕
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 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 SHINGRIXâ„¢ or after a previous dose of SHINGRIXâ„¢.