Two-dose recombinant shingles vaccine for healthy adults 40 and older

Randomized, Blinded, Controlled Phase I/Ⅱ Clinical Trial Evaluating the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) for Healthy Individuals Aged 40 Years and Above

This trial will try two doses of a recombinant shingles vaccine in healthy adults aged 40 and over to see how safe it is and whether it produces an immune response.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 645 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Shanghai Institute Of Biological Products (industry)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06932523 on ClinicalTrials.gov

What this trial studies

This interventional Phase I/II program tests two candidate recombinant herpes zoster vaccine formulations given intramuscularly on days 0 and 60, with dose and adjuvant variations. Substudy A (Phase I) enrolls adults 40–49 and ≥50 to compare two dose levels, adjuvant-only controls, saline, and an approved shingles vaccine as a positive control with 12 months of safety follow-up. Substudy B (Phase II) expands age cohorts to 40–49, 50–69, and ≥70, uses the same comparators, and includes a persistence-of-immunity follow-up for selected groups for up to two years. The co-primary focuses are safety and immunogenicity after the two-dose series.

Who should consider this trial

Good fit: Healthy adults aged 40 years and older with no history of herpes zoster or prior chickenpox/shingles vaccination who can consent, attend all visits, and follow contraception requirements if applicable are ideal candidates.

Not a fit: People with a past history of herpes zoster, prior varicella/zoster vaccination, recent close contact with chickenpox/shingles cases, or who cannot adhere to follow-up schedules are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the candidate could provide an additional safe and effective shingles vaccine option for adults aged 40 and older.

How similar studies have performed: Approved recombinant adjuvanted zoster vaccines (for example, Shingrix) have shown high efficacy, so this CHO-cell recombinant candidate builds on a proven approach though its exact formulation is novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 40 years old on the day of enrollment, gender not limited.
* Can provide legal proof of identity.
* Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment.
* Be able to participate in all planned follow-up visits and comply with all trial procedures.
* On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature).
* Chronic disease patients need to be in a stable period of chronic disease.
* Female and male participants of childbearing age agreed to adopt strict and effective contraceptive measures from the start of the trial to 6 months after full exemption.

Exclusion Criteria:

* Individuals with a history of herpes zoster in the past.
* Individuals with a history of vaccination against chickenpox or shingles.
* Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years.
* Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period.
* Individuals who are allergic to any component of the vaccine or have a history of other severe allergies.
* Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period.
* Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior to receiving the experimental vaccine.
* Any experimental or unregistered product (drug, vaccine, biological product or device) other than the experimental vaccine has been used within one month prior to vaccination, or is planned to be used during the trial period.
* Administer non live vaccines within 7 days prior to administering the experimental vaccine or live vaccines within 14 days prior to administering the experimental vaccine.
* Suffering from a serious illness that prevents the completion of the entire experiment.
* Received immunosuppressive therapy or other immunomodulatory drugs, monoclonal antibodies, thymosin, interferon, etc. within 6 months prior to vaccination with the experimental vaccine, or planned to receive such treatment within 1 month after the first dose to full immunization, but local medication is allowed.
* Chemotherapy, radiotherapy, and organ and bone marrow transplantation related treatments for cancer or other diseases.
* Diseases or medical measures that lead to immune dysfunction
* Individuals currently suffering from serious infectious diseases such as active tuberculosis and active viral hepatitis.
* Moderate or severe acute illness/infection, or febrile illness within 72 hours prior to vaccination.
* Known to have a history of thrombocytopenia, any coagulation dysfunction, or being treated with anticoagulants.
* Suffering from serious cardiovascular disease, pulmonary edema, serious liver and kidney disease, and diabetes that cannot be controlled by drugs.
* Previous history of mental and neurological disorders or family history of mental illness.
* Currently suffering from various severe infectious, suppurative, and allergic skin diseases.
* Plan to move before the end of the trial or leave the local area for a long time during the scheduled trial visit.
* (Phase I ) Abnormal blood routine, blood biochemistry, coagulation, and urine routine indicators before vaccination (excluding those judged by doctors to have no clinical significance).
* Any situation that the researcher believes may affect the evaluation of the experiment.

Where this trial is running

Wuhan, Hubei

• Hubei Provincial Center for Disease Control and Prevention — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Yeqing Tong — Hubei Provincial Center for Disease Control and Prevention
• Study coordinator: Chaorong Xu

Conditions: Herpes Zoster, herpes zoster, recombinant herpes zoster vaccine, vaccine, safety, immunogenicity