Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HZ/su vaccine · 5 trials · 1 indication
A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed in two ways: * By PCR; * By the HZ Ascertainment Committee (HZAC).
A participant with vaccine response for anti-gE was defined as a participant with: * at least a 4-fold greater post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who were seropositive at baseline, or * at least a 4-fold greater post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who were seronegative at baseline.
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).
Anti-S antibody concentrations were determined by Multiplex Electrochemiluminescence assay and expressed as GMCs in arbitrary units per milliliter (AU/mL).
Antibody titers against the 4 influenza strains (A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage) included in the FLU D-QIV vaccine were determined by hemagglutination inhibition and expressed as GMTs.
Anti-S antibody concentrations were determined by Multiplex Electrochemiluminescence assay and expressed as GMCs in AU/mL.
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.
Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.
Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)
Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)
Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)
Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.
| Arm | Type | Description |
|---|---|---|
| LTFU Group | OTHER | Participants who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and are followed for long-term vaccine efficacy and safety in the current ZOSTER-101 study. |
| 1-Additional Dose Group | OTHER | Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and one additional dose of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study. |
| Revaccination Group | OTHER | Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and two additional doses of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study. |
| Control Group | OTHER | Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the ZOSTER-049 study, but who served as a control for the two groups that received 1 or 2 additional doses of HZ/su (1-Additional Dose and Revaccination groups). In the current ZOSTER-101 study, this Control group is used in the evaluation of the long-term vaccine efficacy, safety and as a control for persistence of immunogenicity to additional doses administered in ZOSTER-049 study. |
| HZ/su Group | EXPERIMENTAL | Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2. |
| Placebo Group | PLACEBO_COMPARATOR | Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2. |
| HZ/suSeq Group | ACTIVE_COMPARATOR | Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10. |
| HZ/suCoAd Group | EXPERIMENTAL | Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8. |
| FluD-QIVSeq Group | ACTIVE_COMPARATOR | Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2. |
| FluD-QIVCoAd Group | EXPERIMENTAL | Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1. |
| Co-Ad Group | EXPERIMENTAL | Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm |
| Name | Type | Description |
|---|---|---|
| HZ/su vaccine | BIOLOGICAL | No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR) |
| HZ/su | BIOLOGICAL | Two doses of the HZ/su vaccine administered intramuscularly, one each at Day 1 and Month 2. |
| Placebo | DRUG | Two doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) administered intramuscularly, one each at Day 1 and Month 2. |
| Flu D-QIV | COMBINATION_PRODUCT | 1 dose of Flu D-QIV vaccine administered intramuscularly, either sequentially (FluD-QIVSeq Group) or simultaneously (FluD-QIVCoAd Group) with the mRNA-1273 booster dose. |
| mRNA-1273 | BIOLOGICAL | 1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups). |
| HZ/su vaccine (GSK1437173A) | BIOLOGICAL | 2 intramuscular (IM) revaccination doses of the HZ/su vaccine administered - first dose at Month 24 and second dose at Month 25. |
| HZ/su vaccine GSK1437173A | BIOLOGICAL | 2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm. |
| Prevenar13 | BIOLOGICAL | 1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm. |
Inclusion Criteria: * Participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specifi...
The HZ/su vaccine is an investigational vaccine being developed for the prevention of Herpes Zoster, commonly known as shingles. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The vaccine is designed to generate an immune response against the varicella-zoster virus, which causes shingles.
The HZ/su vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting multiple Phase 3 clinical trials to evaluate the vaccine's safety, immunogenicity, and efficacy in various adult populations, including older adults and those with certain medical conditions.
The HZ/su vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet received regulatory approval. GSK has completed four Phase 3 trials and has one active Phase 3 trial ongoing, with a total enrollment of over 6,000 participants across these studies.
The HZ/su vaccine has been studied in several Phase 3 trials, including NCT04176939, which evaluated long-term immune response in kidney transplant adults; NCT05047770, which assessed co-administration with influenza and COVID-19 boosters; NCT05219253, a study in adults aged 50 and older in India; and NCT05371080, an ongoing long-term efficacy and safety study in older adults.
The HZ/su vaccine is a subunit vaccine that contains a specific antigen from the varicella-zoster virus, the virus that causes shingles. By presenting this antigen to the immune system, the vaccine stimulates the production of antibodies and cellular immune responses, which help protect against the development of Herpes Zoster. The exact formulation and adjuvant system are part of GSK's proprietary technology.
The HZ/su vaccine is an investigational vaccine developed by GSK, and it is not the same as Shingrix, which is an approved vaccine for Herpes Zoster. While both are subunit vaccines targeting the same virus, the HZ/su vaccine is a distinct product candidate currently in Phase 3 trials, and its safety and efficacy profile is still being evaluated.