Shingles, influenza, COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Current interventions as of 22/10/2024:
To test the immunogenicity and safety of giving the recombinant herpes zoster with adjuvant (shingles) vaccine, at the same time as either the COVID-19 bivalen
129 participants to groups 1 and 2, and 258 participants to groups 3-5. Only 129 participants in group 3 will progress to the second and third vaccination time points required to assess COVID-19 vacci
129 participants to groups 1 and 2, and 258 participants to groups 3
Sponsors
University Hospitals Bristol and Weston NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/11/2023: 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol 2. Written informed consent obtained from the participant prior to any study-specific procedure 3. Adults aged 50 years and over at the time of randomisation 4. Participants must have documented history (e.g. NHS app, GP record) or receiving their initial course (usually two doses) of any type of COVID-19 vaccinaiton, irrespective of the type of COVID-19 vaccine received. 5. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first vaccination continuously until 3 months after final vaccination* *A woman of childbearing potential is defined as a pre-menopausal female who is capable of becoming pregnant _____ Previous inclusion criteria: 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol 2. Written informed consent obtained from the participant prior to any study-specific procedure 3. Adults aged 50 years and over at the time of randomisation 4. Participants must have documented previous COVID-19 vaccination in line with UK recommendations at the time of the study 5. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first vaccination continuously until 3 months after final vaccination* *A woman of childbearing potential is defined as a pre-menopausal female who is capable of becoming pregnant
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 22/10/2024: 1. Any clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study. 2. History of reaction or hypersensitivity likely to be exacerbated by any component of the study intervention including allergic reaction to any component of any of the study vaccines, known reactions related to study vaccines e.g. history of myocarditis, GuillainBarre Syndrome. 3. Unstable medical condition on the day of enrolment as determined by clinical history and examination. 4. Bleeding disorders or continuous use of anticoagulation medicine, such as coumarins and related anticoagulants (i.e., warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban). Use of aspirin is allowed. 5. Any confirmed or suspected immunosuppressive, or immunodeficient condition, based on medical history and physical examination. People living with HIV that is well controlled can be included in the study.* Those with a new diagnosis or an AIDs defining illness in the past 12 months cannot be included. 6. Use of immunosuppressive medication, ongoing, long term or planned, defined as more than 14 days in total of immunosuppressant treatments. For corticosteroids this will mean more than 14 days of prednisolone >20mg/day or equivalent. Use of inhaled, intraarticular and topical steroids is allowed. 7. Use or planned use of long-acting immune modifying drugs in the 12-month period before randomisation (e.g. infliximab). 8. COVID-19 or influenza vaccination 90 days prior to the study vaccination 9. Previous vaccination with a live herpes zoster vaccine within the past 5 years. 10. Administration of monoclonal antibodies (including those targeting SARS CoV2), immunoglobulins and/or blood products during the 3 months before the first dose of the study vaccines, up to 1 month after the last dose or planned during the study period. 11. Planning to or concurrently participate in another interventional clinical study. 12. Pregnancy, lactation or willingness/intention to become pregnant within the study period. 13. Previous participation in the ZosterFluCOV trial. *Defined as less than 50 copies/ml (convert as needed from IU/ml) on the last two occasions >3 months apart, and a CD4 over 500 when last checked. Previous participant exclusion criteria as of 23/11/2023: 1. Any clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study 2. History of reaction or hypersensitivity likely to be exacerbated by any component of the study intervention including allergic reaction to any component of any of the study vaccines, known reactions related to study vaccines e.g. history of myocarditis, Guillain-Barre Syndrome 3. Unstable medical condition on the day of enrolment as determined by clinical history and examination 4. Bleeding disorders 5. Any confirmed or suspected immunosuppressive, or immunodeficient condition, based on medical history and physical examination. People living with HIV that is well controlled can be included in the study.* Those with a new diagnosis or an AIDs defining illness in the past 12 months cannot be included. 6. Use of immunosuppressive medication, ongoing, long term or planned, defined as more than 14 days in total of immunosuppressant treatments. For corticosteroids this will mean more than 14 days of prednisolone >20 mg/day o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/10/2024: Immunogenicity: 1. Immunogenicity, measured by S-binding total Ig, 1 month after COVID-19 vaccine given alone compared to coadministration with RZV (first or second dose) 2. Immunogenicity, measured by haemagglutination inhibition assay (HAI), 1 month after aQIV for all four strains included in the vaccine given alone compared to coadministration with RZV 3. Immunogenicity of two doses of RZV vaccine, measured by total antibody against glycoprotein E (total anti-gE antibody concentrations) measured by enzyme-linked immunosorbent assay (ELISA), 1 month after the second dose, given alone, compared to coadministration with COVID-19 vaccine or aQIV with either the first or second dose of RZV Safety: 1. Rate of grade 3 and 4 solicited systemic adverse reactions (SSR) recorded over 7 days after 1st and 2nd doses of RZV given alone compared to coadministration with COVID-19 vaccine 2. Rate of grade 3 and 4, solicited systemic adverse reactions recorded over 7 days after 1st and 2nd doses of RZV given alone compared to co-administration with aQIV Previous primary outcome measure: Immunogenicity: 1. Immunogenicity, measured by S-binding total Ig, 1 month after Bivalent vaccine given alone compared to coadministration with RZV (first or second dose) 2. Immunogenicity, measured by haemagglutination inhibition assay (HAI), 1 month after aQIV for all four strains included in the vaccine given alone compared to coadministration with RZV 3. Immunogenicity of two doses of RZV vaccine, measured by total antibody against glycoprotein E (total anti-gE antibody concentrations) measured by enzyme-linked immunosorbent assay (ELISA), 1 month after the second dose, given alone, compared to coadministration with Bivalent vaccine or aQIV with either the first or second dose of RZV Safety: 1. Rate of grade 3 and 4 solicited systemic adverse reactions (SSR) recorded over 7 days after 1st and 2nd doses of RZV given alone compared to coadmin | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 22/10/2024: 1. Cell-mediated responses to two doses of RZV, measured using glycoprotein E specific CD4+ cells measured by intracellular cytokine staining 1 month after the second dose, given alone compared to co-administration with COVID-19 vaccine with 1st or 2nd dose of RZVA 2. Exploratory evaluation of CD4+ T-cells against COVID-19 using S and N protein-specific T-cells measured by ELISpot after vaccination with RZV or aQIV (CMI cohort) 3. N- N-protein immunoglobulin measured using total antibody against N-protein (total anti-N protein antibody concentration) measured by electrochemiluminescence immunoassay (ECLIA) before and 1 month after the first vaccination in the (exploratory immunology cohort 4. Grade 3 and 4 SSR recorded after 1st RZV dose in group 1 (day 56), group 2 and 5 (day 0) compared to grade 3 SSR recorded after 1st dose of RZV with COVID-19 vaccine in group 3 (day 56) 5. Grade 3 and 4 SSR recorded after 1st dose RZV in group 1 (day 56), group 2 and 5 (day 0) compared to grade 3 SSR recorded after 1st dose of RZV with aQIV in group 4 (day 0) 6. Grade 3 and 4 SSR recorded after the 2nd dose of RZV in group 1 (day 112), group 3 (day 112) and group 4 (day 56) compared to grade 3 SSR recorded after the 2nd dose RZV with aQIV in group 5 7. SSR events recorded over 7 days after 1st and 2nd doses of RZV given alone compared to co-administration with either COVID-19 vaccine or aQIV 8. Solicited local adverse reactions recorded over 7 days after 1st or 2nd doses of RZV given alone compared to co-administration with either COVID-19 vaccine or aQIV Qualitative outcomes: 1. Participant acceptance of multiple vaccinations (2 or more) for future routine vaccinations 2. Trial staff perceptions on offering multiple vaccinations (2 or more) for future routine vaccinations Previous secondary outcome measure: 1. Cell-mediated responses to two doses of RZV, measured using glycoprotein E specific CD4+ cells measured by intra | — |
Countries
England, United Kingdom
Contacts
Public ContactRachael Heys
Outcome results
None listed