Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05769049
Other study ID # REC610C102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 9, 2023
Est. completion date December 6, 2023

Study information

Verified date February 2024
Source Jiangsu Rec-Biotechnology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.


Description:

The primary objective is to evaluate the safety and reactogenicity of REC610, and the secondary objective is to evaluate the immunogenicity of REC610. The study will include younger (40 to 59 years, included) and older (60 years and above) healthy adult participants in 2 separate age groups. Totally 48 eligible participants, 24 for each age group, will be enrolled in the study with a 2:1 randomization ratio to receive REC610 (50 μg) or Shingrix® (50 μg) respectively. The study will progress in a sequential manner, with the younger adult group being enrolled and vaccinated first. The Safety Monitoring Committee (SMC) will review the safety data after all participants in the younger adult group complete the 7 days visit after the first vaccination. The older adult enrollment will commence only after the SMC's review is completed. Participants will undertake a Screening Visit between Day -7 and Day -1 to determine their eligibility. The eligible participants will be randomized to receive the first dose vaccination on Day 0, and the second dose vaccination at 60 days (+14 days) post the first dosing, according to the allocated group. Verification on the criteria for vaccination postponement or termination should be performed before the second dosing. Additionally, all the participants will return to the study site for ongoing assessments of safety and immunogenicity as per the Schedule of Assessments Visits. Sentinels will be employed for each age group during the first dose vaccination. Each age group will include 3 sentinel participants (2 REC610, 1 Shingrix®) who will be dosed first and monitored by the Investigator for at least 2 hours at the study site; discharge will only be allowed per agreement by the Investigator. After 48 hours post the study vaccination, the sentinel participants will be contacted by site staff via telephone/text message/other mode to collect and record AEs. Once the dose is deemed to be safe by the absence of significant safety issues in the sentinels, in consultation with the study Medical Monitor and Sponsor as needed, the remaining participants in the age group will be randomized (2:1) to receive REC610 or Shingrix®, respectively. The decision to dose the rest of the age group will be documented. All participants will be followed up for safety and reactogenicity. Participants will be observed for 30 minutes at study site after each dosing. For the sentinels, the observation requires to be at least 2 hours post the first dosing. Before leaving the study site, participants will be given diaries and be trained on recording solicited AEs within 7 days and unsolicited AEs within 30 days after each dosing. All participants will return to study site on Day 7 (+3 days) for safety clinical laboratory assessment. Besides, the occurrence of SAEs and AESIs will be monitored from the first dose vaccination till 6 months after the second dose vaccination. In addition, all participants will be followed up for immunogenicity. Blood samples will be collected on Day 0 (before the study vaccination), at 60 days after the first dose vaccination (+14 days, before the second dose vaccination), 30 days (+7 days), 3 months (+15 days), and 6 months (+30 days) after the second dose vaccination, respectively, for testing of gE specific antibodies and assessing on the cellular immune response. Blood samples will be sent to the central laboratory for the immunogenicity testing. During the whole study period, if participants have any signs or symptoms related to HZ, the diagnosis and necessary management will be performed per local clinical practice at the study site. After HZ diagnosis is confirmed, the participants will receive safety follow-up only during the leftover study stage. Interim Analysis & Final Analysis The interim analysis (IA) is planned after all participants complete 30 days visit post the second dose vaccination, to evaluate safety and immunogenicity during this period. The IA for each age group may be conducted separately, depending on the actual enrollment progress. The IA will be performed by an independent statistic group, while the sponsor will be kept blinded from participant's individual randomization information. The investigators, all study participants and study team members except for unblinded staff assigned for IPs management and monitoring at site, will be kept blinded during the entire study period. The results of IA will support the design on following clinical trials for REC610. Within the IA, all the study procedures for long-term follow-up will be continued. The Final Analysis (FA) will be conducted after all participants complete the follow-up visit at 6 months after the second dose vaccination, to evaluate long-term safety and immune persistency.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 6, 2023
Est. primary completion date December 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Male or female aged 40 years and older. - Able and willing to comply with all study requirements. - Willing to allow the investigators to discuss the volunteers' medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures. - Healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. Exclusion Criteria: - Known history of COVID-19 within 6 months prior to randomization, or being defined as SARS-CoV-2 infection by RT-PCR assay during the screening. - Fever (oral temperature = 37.5°C / axillary temperature = 37.3°C) on the day of vaccination, or having fever within recent 72 hours before the vaccination. - Known history of herpes zoster. - History of varicella or herpes zoster vaccination. - Having abnormal results of clinical laboratory testing during screening, which is judged by the investigator with clinical significance, including the hematology, blood chemistry, and urinalysis. - History of severe allergic diseases or reactions likely to be exacerbated by any component of investigational vaccine, including the adjuvant components (e.g., QS-21, MPL, common in foamer for beverage, emulsive flavor composition, vitamin E, mildew preventive, and part of Chinese herbal medicine, e.g., ginseng, balloon-flower root, liquorice), such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local hypersensitive necrosis reaction (Arthus reaction), prior history of serious adverse reaction to any vaccine or drug, such as acute allergy, urticaria eczema, dyspnea, and angioneurotic edema. - Having malignant tumors (except for skin basal cell carcinoma or carcinoma uterine cervix in situ), immune diseases (e.g., known documented human immunodeficiency virus [HIV] infection, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy, and others that may influence immune response at the investigator's discretion).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
REC610
administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older
Shingrix
Shingrix

Locations

Country Name City State
Philippines Pharma Peak Research Philippines,Inc. Makati City Metro Manila

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Rec-Biotechnology Co., Ltd.

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of related AE The incidence of investigational product (IP)-related adverse events (AEs) within 30 days after each dose vaccination. within 30 days after each dose vaccination
Primary Incidence of solicited AE The incidence of solicited local and systemic AEs within 7 days after each dose vaccination. within 7 days after each dose vaccination
Primary Incidence of unsolicited AEs The incidence of unsolicited AEs within 30 days after each dose vaccination. within 30 days after each dose vaccination
Primary Incidence of clinically significant abnormalities in clinical laboratory tests The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, and urinalysis) on Day 7 after the first dose vaccination Day 7 after the first dose vaccination
Primary Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs) The occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs) till 6 months after the second dose vaccination 6 months after the second dose vaccination
Secondary The seroconversion rate (SCR) at timepoints during the study The seroconversion rate (SCR) of glycoprotein E (gE) specific antibody at 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination. 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Secondary The geometric mean titer (GMT) at timepoints during the study The geometric mean titer (GMT) of glycoprotein E (gE) specific antibody at 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination. 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Secondary The geometric mean increase (GMI) at timepoints during the study The geometric mean increase (GMI) of glycoprotein E (gE) specific antibody at 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination. 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Secondary Frequencies of CD4+ T cells secreting at least one of gE specific cytokines (e.g., IFN-?, IL-2, TNF-a, CD40L) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study The frequencies of CD4+ T cells secreting at least one of gE specific cytokines (e.g., IFN-?, IL-2, TNF-a) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination. 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Secondary Frequencies of CD4+ T cells secreting at least two of gE specific cytokines (e.g., IFN-?, IL-2, TNF-a) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study The frequencies of CD4+ T cells secreting at least two of gE specific cytokines (e.g., IFN-?, IL-2, TNF-a, CD40L) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination. 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
See also
  Status Clinical Trial Phase
Completed NCT03120364 - Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over Phase 3
Completed NCT01165203 - Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects Phase 2
Recruiting NCT06088745 - A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine Phase 3
Completed NCT01385566 - A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2) Phase 1
Completed NCT01137669 - ZOSTAVAX® in Renal Transplant Patients Phase 1
Completed NCT01911065 - T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020 Phase 4
Completed NCT00550745 - ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020) Phase 4
Completed NCT01132729 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions N/A
Completed NCT01132716 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions N/A
Completed NCT02852876 - Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food Phase 1
Completed NCT00231816 - A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011) Phase 3
Completed NCT05082688 - Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX) Phase 2
Completed NCT04099706 - Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT N/A
Active, not recruiting NCT04091451 - A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles Phase 3
Completed NCT02519855 - Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062) Phase 3
Completed NCT04523246 - Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents Early Phase 1
Completed NCT05047770 - A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine Phase 3
Completed NCT03314103 - Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age Phase 3
Completed NCT01527370 - Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) Phase 3
Completed NCT01954251 - Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older Phase 3