Active — Not RecruitingPhase 2

Phase II Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above

China300 participantsStarted 2025-11-15

Plain-language summary

The primary objective of this study is to evaluate the immunogenicity and safety of 2 injections (approximately 2 months apart) of ABO1108 in adults aged 40 years or above.

Who can participate

Age range40 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

✓. Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee and agree to participate in the trial before undergoing any trial procedures.
✓. Healthy adults ≥40 years of age, participants with underlying diseases that are stably controlled may be accepted.
✓. Willing to and physically able to communicate with the investigators, understand and comply with protocol required follow-up, simple self-observation and recording using the Diary Card.
✓. Male participants (and their female partners) and female participants of childbearing potential agree to continue effective contraception through 6 months following vaccination.

Exclusion criteria

✕. Acute illness or fever on the day of vaccination or within 3 days prior to vaccination, or use of anti-inflammatory, anti-allergy, antibiotic, or antiviral medications due to physical discomfort.
✕. Clinically significant abnormal vital signs, including but not limited to:
✕. Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential.
✕. History of allergy to any ingredient of the investigational products, or severe allergic reactions to other vaccines, foods, or medications.
✕. History of herpes zoster at any previous time, history of varicella or close contact with varicella/herpes zoster patients within the past year.
✕. Previous vaccination with herpes zoster or varicella vaccine (including marketed or investigational vaccines) or planned vaccination during the trial period.
✕. Use or planned use of any vaccine other than the investigational products through 30 days prior to and 30 days after vaccinations in this trial.
✕. Current participation in another clinical trial within 6 months prior to vaccination or planned participation before the end of this trial.

What they're measuring

Geometric Mean value (GMT or GMC) of Serum gE-specific IgG antibody and VZV antibody

Timeframe: Up to Day 90 (30 days after the last dose)

Geometric Mean Increase versus Postbaseline/Baseline Ab Titers

Timeframe: Up to Day 90 (30 days after the last dose)

gE-specific T cell responses

Timeframe: Up to Day 90 (30 days after the last dose)

Trial details

NCT IDNCT07285278

SponsorSuzhou Abogen Biosciences Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-09

View on ClinicalTrials.gov More Varicella-zoster Virus trials

Who can participate

Age range40 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

✓. Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee and agree to participate in the trial before undergoing any trial procedures.
✓. Healthy adults ≥40 years of age, participants with underlying diseases that are stably controlled may be accepted.
✓. Willing to and physically able to communicate with the investigators, understand and comply with protocol required follow-up, simple self-observation and recording using the Diary Card.
✓. Male participants (and their female partners) and female participants of childbearing potential agree to continue effective contraception through 6 months following vaccination.

Exclusion criteria

✕. Acute illness or fever on the day of vaccination or within 3 days prior to vaccination, or use of anti-inflammatory, anti-allergy, antibiotic, or antiviral medications due to physical discomfort.
✕. Clinically significant abnormal vital signs, including but not limited to:
✕. Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential.
✕. History of allergy to any ingredient of the investigational products, or severe allergic reactions to other vaccines, foods, or medications.
✕. History of herpes zoster at any previous time, history of varicella or close contact with varicella/herpes zoster patients within the past year.
✕. Previous vaccination with herpes zoster or varicella vaccine (including marketed or investigational vaccines) or planned vaccination during the trial period.
✕. Use or planned use of any vaccine other than the investigational products through 30 days prior to and 30 days after vaccinations in this trial.
✕. Current participation in another clinical trial within 6 months prior to vaccination or planned participation before the end of this trial.

What they're measuring

Geometric Mean value (GMT or GMC) of Serum gE-specific IgG antibody and VZV antibody

Timeframe: Up to Day 90 (30 days after the last dose)

Geometric Mean Increase versus Postbaseline/Baseline Ab Titers

Timeframe: Up to Day 90 (30 days after the last dose)

gE-specific T cell responses

Timeframe: Up to Day 90 (30 days after the last dose)