Herpes ZosterPhase 1NCT05769049
The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)
A Phase 1 study testing REC610 and Shingrix in people with Herpes Zoster, run by Jiangsu Rec-Biotechnology Co., Ltd. at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- REC610 and Shingrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePhilippines
- Study dates
- 9 Feb 2023to 6 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Pharma Peak Research Philippines,Inc.
Makati City, National Capital Region
About this study
Official title: A Randomized, Observer-Blinded, Active-Controlled, Phase I Study to Evaluate the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell) in Healthy Adults Aged 40 Years and Older
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.
Read the detailed 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.
- Conditions
- Herpes Zoster
- Being tested
- REC610, Shingrix
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REC610Biological
Also called Recombinant Zoster Vaccine (CHO cell)
administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older
ShingrixBiological
Also called Recombinant Zoster Vaccine (CHO cell)
Shingrix
| Study group | Role | What they receive |
|---|---|---|
| REC610 | Experimental | Lyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection BFA01 adjuvant suspension: opalescent white liquid After reconstitution: opalescent white liquid. Each dose (0.5 mL) contains 50 μg of Quillaja Saponin (QS-21), 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol Receives: Biological: REC610 |
| Shingrix | Active comparator | Lyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection AS01B adjuvant suspension: opalescent, colorless to pale brownish liquid suspension After reconstitution: opalescent, colorless to pale brownish liquid. Each dose (0.5 mL) contains 50 μg of QS-21, 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of related AE
The incidence of investigational product (IP)-related adverse events (AEs) within 30 days after each dose vaccination.
Measured: within 30 days after each dose vaccination
Incidence of solicited AE
The incidence of solicited local and systemic AEs within 7 days after each dose vaccination.
Measured: within 7 days after each dose vaccination
Incidence of unsolicited AEs
The incidence of unsolicited AEs within 30 days after each dose vaccination.
Measured: within 30 days after each dose vaccination
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
Measured: Day 7 after the first dose vaccination
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
Measured: 6 months after the second dose vaccination
Secondary outcomes (5)
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.
Measured: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
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.
Measured: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
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.
Measured: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Frequencies of CD4+ T cells secreting at least one of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α, 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-γ, IL-2, TNF-α) 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.
Measured: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Frequencies of CD4+ T cells secreting at least two of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α) 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-γ, IL-2, TNF-α, 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.
Measured: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start9 Feb 2023
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Loreta Zoleta- De Jesus, Dr., Principal investigator, Silang Specialists Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769049
- Sponsor's protocol ID
- REC610C102
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blinded, Active-Controlled, Phase I Study to Evaluate the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell) in Healthy Adults Aged 40 Years and Older
- ClinicalTrials.gov ID
- NCT05769049
- Acronym / sponsor ID
- REC610C102
- Conditions
- Herpes Zoster
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| REC610 | Experimental | Biological: REC610Lyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection BFA01 adjuvant suspension: opalescent white liquid After reconstitution: opalescent white liquid. Each dose (0.5 mL) contains 50 μg of Quillaja Saponin (QS-21), 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol |
| Shingrix | Active comparator | Biological: ShingrixLyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection AS01B adjuvant suspension: opalescent, colorless to pale brownish liquid suspension After reconstitution: opalescent, colorless to pale brownish liquid. Each dose (0.5 mL) contains 50 μg of QS-21, 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REC610Also: Recombinant Zoster Vaccine (CHO cell)administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older | Biological | REC610 |
| ShingrixAlso: Recombinant Zoster Vaccine (CHO cell)Shingrix | Biological | Shingrix |
Primary outcome
Incidence of related AE
Time frame: within 30 days after each dose vaccination
The incidence of investigational product (IP)-related adverse events (AEs) within 30 days after each dose vaccination.
Incidence of solicited AE
Time frame: within 7 days after each dose vaccination
The incidence of solicited local and systemic AEs within 7 days after each dose vaccination.
Incidence of unsolicited AEs
Time frame: within 30 days after each dose vaccination
The incidence of unsolicited AEs within 30 days after each dose vaccination.
Incidence of clinically significant abnormalities in clinical laboratory tests
Time frame: Day 7 after the first dose vaccination
The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, and urinalysis) on Day 7 after the first dose vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Time frame: 6 months after the second dose vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs) till 6 months after the second dose vaccination
5 secondary outcomes
The seroconversion rate (SCR) at timepoints during the study
Time frame: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
The geometric mean titer (GMT) at timepoints during the study
Time frame: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
The geometric mean increase (GMI) at timepoints during the study
Time frame: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Frequencies of CD4+ T cells secreting at least one of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α, CD40L) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study
Time frame: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Frequencies of CD4+ T cells secreting at least two of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study
Time frame: 60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreta Zoleta- De Jesus, Dr. principal investigator
Silang Specialists Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REC610 and Shingrix in people with Herpes Zoster, run by Jiangsu Rec-Biotechnology Co., Ltd. at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of related AE (time frame: within 30 days after each dose vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.