Use of Recombinant Zoster Vaccine (RZV) 

in Immunocompromised Populations 

Robyn Widenmaier, Global Medical Portfolio Lead, Zoster Vaccine 

ACIP Presentation 

June 25, 2021 
4.47 

8.03 

8.6 

7.55 – 9.31 

12.1 – 12.24 

9.3 –17.41 

18.3 

12.3 – 22.05 

24.4 – 28 

31.6 – 40.0 

42.4 – 95.6 

12.0 – 15.19 

31.4 – 66.2 

0 20 40 60 80 100 120 

Incidence Rates of HZ in Adult Patients 

Incidence rate (per 1,000 person-years) 

 

 

 

 

 

 

Immuunnoocomppeeten tentt ((aall ll aages) ges)17 

Unmet Need: Patients With Immunocompromising 

Conditions Have a Higher Risk of HZ 

Bone marrow or stem cell transplant 1-5 

Hematologic malignancies6,7 

Heart transplant 8,9 

Renal transplant 9,10 

Solid tumors 6,11,12 

Liver transplant 9 

HIV infection 1,13 

Systemic lupus erythematosus1,14 

Rheumatoid arthritis 1,15 

Inflammatory bowel disease1,16 

Multiple sclerosis1 

Psoriasis 1

HIV, human immunodeficiency virus; HZ, herpes zoster. 

1. Chen SY, et al. Infection. 2014;42(2):325-334. 2. Zhang D, et al. Adv Therapy. 2017 Jul 1;34(7):1610-21. 3. Sahoo F, et al. Biol Blood Marrow Transplant. 2017;23(3):505-11. 4. Winston DJ, et al. 

Lancet. 2018;391(10135):2116-27. 5. Bastidas A, et al. JAMA. 2019;322(2):123-33. 6. Habel LA, et al. Cancer Epidemiol Biomarkers Prev. 2013;22(1):82-90. 7. Dagnew AF, et al. Lancet Infect Dis. 

2019;19(9):988-1000. 8. Koo S, et al. Transpl Infect Dis. 2014;16(1):17-25. 9. Pergam SA, et al. Transpl Infect Dis. 2011;13(1):15-23. 10. Arness T, et al. Transpl Infect Dis. 2008;10(4):260-268. 11. 

Mao J, et al. Medicine (Baltimore). 2017;96(48):e8746.12. Tseng HF, et al. Clin Infect Dis. 2014;59(7):913-919.13. Blank LJ, et al. J Acquir Immune Defic Syndr. 2012;61(2):203-207. 14. Chakravarty 

EF. Rheum Dis Clin North Am. 2017;43(1):111-121. 15. Veetil BM, et al. Arthritis Care Res (Hoboken). 2013 Jun;65(6):854-61. 16. Khan N, et al. Clin Gastroenterol Hepatol. 2018;16(12):1919-27.e3. 

17. Johnson et al. BMC Infect Dis (2015);15:502 
 

 

Underlying

Disease

Addressing the Unmet Need 

Addressing the Unmet Need in Immunocompromised (IC) Adults (≥18 YOA)

•

•

•

–

–

–

–

Immunosuppressive therapy (IS) 

Underlying disease 

Age 

• RZV was licensed by FDA on October 20, 20173 

• No safety concerns identified in clinical trials1 -2 

• RZV demonstrated >90% efficacy in Immunocompetent Older Adults (≥50 YOA)1 -2 

IC populations are very heterogeneous, both across and within groups 

Not feasible to define every possible IC condition/medication combination 

Immune responses and vaccine safety in IC populations are primarily 

influenced by: 

Timing of vaccination (before, during, after therapy) 

Age 

IS therapy 

Timing 

of Vacc. Underlying 

Disease 

IC, immunocompromised; IS, immunosuppressive; RZV, recombinant zoster vaccine; Vacc, vaccination; YOA, years of age 

1. Lal et al. N Engl J Med 2015;372:2087-96. 2. Cunningham et al. N Engl J Med 2016;375:1019-32. 3. Shingrix Prescribing information: US FDA; [revised March 2021]. Available from: 

https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF 3 
 

 

 

 

Addressing the Unmet Need 

RZV Clinical Development Program in IC Populations 

Phase I/II 

Phase III 

Autologous Hematologic Malignancies Solid Tumors (ST)3* Renal Transplant (RT)4 

Hematopoietic Stem Cell (HM)2 Immunogenicity, Safety Immunogenicity, Safety 

Transplant (auHSCT)1 Immunogenicity, Safety, N=232 N=264 

Efficacy, Immunogenicity, Post-hoc Efficacy 

Safety N=562 

N=1846 

Human Immunodeficiency Autologous Hematopoietic 

Virus (HIV)5 Stem Cell Transplant 

Immunogenicity, Safety (auHSCT)6 

N=123 Immunogenicity, Safety 

N=89 

*Phase II/III study. 

IC, immunocompromised; RZV, recombinant zoster vaccine. 

1. Bastidas, et al. JAMA. 2019;322(2):123-133. 2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988-1000. 3. Vink P, et al. Cancer. 2019;125(8):1301-1312. 4. Vink P, et al. Clin Infect 

Dis. 2020;70(2):181-190. 5. Berkowitz EM, et al. J Infect Dis. 2015;211(8):1279-1287. 6. Stadtmauer EA, et al. Blood. 2014;124(19):2921-2929. 4 
 

 

 

Underlying Disease 

Autologous 

Hematopoietic Stem 

Cell Transplant 

(auHSCT)1 

Hematologic 

Malignancies (HM)2 Solid Tumors (ST)3* Renal Transplant (RT)4 

Age 18+ (18-49, 50+) 18+ (18-49, 50+) 18+ (18-49, 50+) 18+ (18-49, 50+) 

Immunosuppressive 

(IS) Treatment 

Pre-HSCT conditioning, 

Post-HSCT therapy 

(+/- antivirals) 

IS chemotherapy per 

SOC 

IS chemotherapy per 

SOC Chronic IS per SOC 

Timing of 

Vaccination 50-70d post-auHSCT During Chemo (+/- 10d) 

After Chemo (10d–6mo) 

PreChemo†

OnChemo† >4-18 mo post-allograft 

Endpoints Efficacy, 

Immunogenicity, Safety 

Immunogenicity, Safety, 

(Post-hoc Efficacy) Immunogenicity, Safety Immunogenicity, Safety 

Phase III 

† 

 

 

Addressing the Unmet Need 

RZV Phase III Clinical Development in IC Populations 

*Phase II/III study. Dose 1 given either 8-30 days before the start of a cycle (PreChemo group) or at the start of a cycle (OnChemo group). 

Chemo, chemotherapy; d, day; IS, immunosuppressive; Mo, month; RZV, recombinant zoster vaccine; SOC, standard of care. 

1. Bastidas, et al. JAMA. 2019;322(2):123-133. 2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988-1000. 3. Vink P, et al. Cancer. 2019;125(8):1301-1312. 4. Vink P, et al. Clin Infect 

Dis. 2020;70(2):181-190. 5 
 

 

 

 

 

 

IC population ≥18 YOA

Randomization 1:1 (RZV:Placebo) Only for 

M0 M1 M2 M7 M13 M25 

auHSCT1 HM2 RT3 ST4 

7d Solicited AEs 

30d Unsolicited AEs 

SAEs, pIMDs, Pregnancies, HZ, 

Relapses, Disease Progression 

RZV; Placebo; blood sampling for humoral immunogenicity; blood sampling for cell-mediated immunity 

RZV Multicenter Studies in IC Populations Were 

Randomized, Observer-blinded, Placebo-controlled 

AE, adverse event; auHSCT, autologous hematopoietic stem cell transplant; HM, hematologic malignancies, HZ, herpes zoster; IC, immunocompromised; M, month; pIMD, potential 

immune-mediated disease; RT, renal transplant; RZV, recombinant zoster vaccine; SAE, serious adverse event; ST, solid tumor; YOA, years of age. 

1. Data on File, ZOSTER-002 Clinical study report. Available on https://www.gsk-studyregister.com/study/115523 2. Data on File, ZOSTER-039 Clinical study report. Available on 

https://www.gsk-studyregister.com/study/116428 3. Data on File, ZOSTER-041 Clinical study report. Available on https://www.gsk-studyregister.com/study/116886 4. Data on File, 

ZOSTER-028 Clinical study report. Available on https://www.gsk-studyregister.com/study/116427 6 
 

 -

Pooled Reactogenicity in 

Immunocompromised Patients 

Fauqued ML, et al. Safety Profile of the Adjuvanted Recombinant Zoster Vaccine (RZV) in Immunocompromised Populations: an Overview of 6 

Trials. Presented at: IDWeek 2020 (virtual event). October 21 25, 2020. https://idweek.org 
Percentage of Participants With Solicited Local AEs 

Reported across 6 pooled studies – 7 days post-vaccination; Overall – TVC % of participants reporting local AEs 

100 91.1 90.2 RZV 18–49 YOA (n=437) 

90 84.2 RZV ≥50 YOA (n=1116) 81.5 

Placebo 18–49 YOA (n=406) 80 

Placebo ≥50 YOA (n=1080) 70 Grade 3 

60 

50 

32.7 34.7 40 

30 21.5 

17.9 14 13.5 20 10.7 9.6 

10 

0.5 1.4 0.2 1.1 

0 

16.7 15.3 

2.3 1.4 

12.3 

9.1 

3.3 0.2 0.2 0.2 0.2 1.3 

 

 

 

 

 

Any Local Pain Redness Swelling 

Solicited local AEs were mostly mild/moderate in intensity and lasted a median of 3 days. Grade 3 solicited local AEs had a median 

duration of 1-2 days. 

 

 

 

 

Graph reproduced from Fauqued ML , 2020. Presented at IDWeek 2020 

Grade 3 was defined as follows: pain that prevented normal activity; >100 mm diameter for redness and swelling; symptoms that prevented normal activity for headache, myalgia, fatigue and 

gastrointestinal symptoms; fever >39.0°C (axillary/oral temperature). 

For the systemic AEs fatigue, headache (all, related), myalgia, shivering, and fever (all, related) were reported with higher incidences in the RZV 18–49 YOA group than in the RZV ≥50 YOA group.

AE, adverse event; RZV, recombinant zoster vaccine; TVC, total vaccinated cohort; YOA, years of age. 

Fauqued ML, et al. Safety Profile of the Adjuvanted Recombinant Zoster Vaccine (RZV) in Immunocompromised Populations: an Overview of 6 Trials. Presented at: IDWeek 2020 (virtual event). 

October 21-25, 2020. https://idweek.org 8 
 

 

 

 

Percentage of Participants With Solicited General AEs 

Reported across 6 pooled studies – 7 days post-vaccination; Overall – TVC 

100 

90 82.1 

80 

70 

60 

50 

40 

30 

20 

10 

0 

RZV 18–49 YOA (n=436) 

RZV ≥50 YOA (n=1117)

64.7 

60.8 

48.9 

27.3 

33.4 

29.6 

73.7 

55.6 

50.4 

32.2 

28.1 25.2 

19.2 

55.8 

42 

25.8 27.3 

19.7 

14.4 

6.1 

50.6 

38.5 

23.7 

19.8 20.4 

11.5 

6.6 

21.6 

13.1 12.8 

5.3 3 

8.3 

1.4 

12.4 

6.2 5.6 2.9 2.1 3 0.5 

8.6 

4.7 3.4 2.7 1.7 0.2 0 

6.8 3.8 1.8 1.4 2 1 0.3 

Placebo 18–49 YOA (n=407) 

Placebo ≥50 YOA (n=1081)

Grade 3 

% of participants reporting 

systemic AEs 

Any Systemic Fatigue Myalgia Headache Gastrointestinal Shivering Fever (≥37.5°C ) 

 

 

 

 

 

 

symptoms 

Solicited general AEs were mostly mild/moderate and lasted ≤3 days. Grade 3 solicited general AEs lasted ≤2 days (median 

duration) Graph reproduced from Fauqued ML , 2020. Presented at IDWeek 2020 

Grade 3 was defined as follows: pain that prevented normal activity; >100 mm diameter for redness and swelling; symptoms that prevented normal activity for headache, myalgia, fatigue and 

gastrointestinal symptoms; fever >39.0°C (axillary/oral temperature). 

For the systemic AEs fatigue, headache (all, related), myalgia, shivering, and fever (all, related) were reported with higher incidences in the RZV 18–49 YOA group than in the RZV ≥50 YOA group.

AE, adverse event; RZV, recombinant zoster vaccine; TVC, total vaccinated cohort; YOA, years of age. 

Fauqued ML, et al. Safety Profile of the Adjuvanted Recombinant Zoster Vaccine (RZV) in Immunocompromised Populations: an Overview of 6 Trials. Presented at: IDWeek 2020 (virtual event). 

October 21-25, 2020. https://idweek.org 9 
 

Unsolicited Adverse Events (AEs) 

Percentage of participants reporting ≥1 unsolicited AE 30 days post-vaccination per 

study – TVC % of participants reporting ≥1 unsolicited AE

100 

90 

80 

70 

60 

50 

40 

30 

20 

10 

0

 

 

 

 

 

37.4 

40.5 

41.7 

80.6 

39.6 

49.8 

36.9 

87.2 

31.4 

35.6 

38.8 

90.0 

40.4 

49.5 

30.1 

89.4 

auHSCT HM RT ST auHSCT HM RT ST 

RZV Placebo 

18–49 YOA ≥50 YOA

N= 230 229 74 73 48 49 31 30 692 695 209 206 84 83 86 85 

Across studies, the percentage of adults reporting ≥1 unsolicited AE was similar between RZV and placebo groups

Error bars represent 95% CI. Each population was evaluated in a separate study. There are no head-to-head comparisons between immunocompromised populations. 

AE, adverse event; auHSCT, autologous hematopoietic stem cell transplant; CI, confidence interval; HM, hematological malignancies; RT, renal transplant; RZV, recombinant zoster 

vaccine; ST, solid tumors patients; TVC, total vaccinated cohort; YOA, years of age. 

Fauqued ML et al. Safety Profile of the Adjuvanted Recombinant Zoster Vaccine (RZV) in Immunocompromised Populations: an Overview of 6 Trials. 

Presented at: IDWeek 2020 (virtual event). October 21-25, 2020. https://idweek.org 10 
Serious Adverse Events (SAEs) 

Percentage of participants reporting ≥1 SAE from dose 1 until 1-year post-last dose 

per study – TVC % of participants reporting ≥1 SAE

100 

90 

80 

70 

60 

50 

40 

30 

20 

10 

0

 

 

 

 

 

20.4 14.9 

22.9 

16.1 31.2 26.3 

17.9 

36.0 

21.8 21.9 

28.6 

30.0 

27.5 

32.0 

22.9 

38.8 

auHSCT HM RT ST auHSCT HM RT ST 

RZV Placebo 

18–49 YOA ≥50 YOA

N= 230 229 74 73 48 49 31 30 692 695 209 206 84 83 86 85 

The percentage of adults with ≥1 SAE, causally related SAEs, fatal SAEs and pIMDs was similar between 

RZV and placebo and between age groups 

Error bars represent 95% CI. Each population was evaluated in a separate study. There are no head-to-head comparisons between immunocompromised populations. 

auHSCT, autologous hematopoietic stem cell transplant; CI, confidence interval; HM, hematological malignancies; RT, renal transplant; RZV, recombinant zoster vaccine; SAE, serious 

adverse event; ST, solid tumors patients; TVC, total vaccinated cohort; YOA, years of age. 

Fauqued ML et al. Safety Profile of the Adjuvanted Recombinant Zoster Vaccine (RZV) in Immunocompromised Populations: an Overview of 6 Trials. 

Presented at: IDWeek 2020 (virtual event). October 21-25, 2020. https://idweek.org 11 
% of participants

reporting ≥1 pIMD 

0.0 

1.1 

0.4 

1.3 

0.2 

1.0 

0.2 

1.1 

0 

1 

2 

3 

Up to 30 days postlast vaccination Up to 1 year post-last 

vaccination 

Up to 30 days postlast vaccination Up to 1 year post-last 

vaccination 

% of participants

reporting ≥1 pIMD 

RZV 

Placebo 

18–49 YOA 

(RZV n=443; 

placebo n=419) 

≥50 YOA

(RZV n=1144; 

placebo n=1110) 

Potential immune mediated diseases (pIMDs) 

Percentage of participants reporting ≥1 pIMD during selected study periods – TVC 

(pooled) 

100 RZV 

90 Placebo 

80 

70 

60 

50 

40 

30 

20 

10 

0 

0.2 1.1 1.0 0.0 

Up to 30 days post- Up to 1 year postlast vaccination last vaccination 

18–49 YOA 

(RZV n=443; 

placebo n=419) 

0.4 0.2 1.3 1.1 

Up to 30 days post- Up to 1 year postlast vaccination last vaccination 

≥50 YOA

(RZV n=1144; 

placebo n=1110) 

pIMD, potential immune mediated disease; TVC, total vaccinated cohort; YOA, years of age. 

Data on file, 2021N477632. 12 
 

 

 

 

Safety: Underlying Disease-related Events 

• Proportion of patients with disease progressions or disease relapse were 

balanced between RZV and placebo groups. 

auHSCT1 HM2 

• 4 biopsy-confirmed allograft rejections in the RZV group. 

• 7 biopsy-confirmed allograft rejections in the placebo group. 

RT3 • No impact on renal-allograft function based on serum creatinine levels. 

Each population was evaluated in a separate study. There are no head-to-head comparisons between immunocompromised populations. 

auHSCT, autologous hematopoietic stem cell transplant; HM, hematologic malignancies, RT, renal transplant; RZV, recombinant zoster vaccine. 

1. Data on File, ZOSTER-002 Clinical study report. Available on https://www.gsk-studyregister.com/study/115523 2. Data on File, ZOSTER-039 Clinical study report. Available on 

https://www.gsk-studyregister.com/study/116428 3. Data on File, ZOSTER-041 Clinical study report. Available on https://www.gsk-studyregister.com/study/116886 13 
 

-

-

Vaccine Efficacy in Immunocompromised 

Patients 

Pivotal Vaccine Efficacy: auHSCT 

Post-hoc Vaccine Efficacy: HM 

auHSCT, autologous hematopoietic stem cell transplant; HM, hematologic malignancies 

1. Bastidas, et al. JAMA. 2019;322(2):123 133. 

2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988 1000. 
 

 

 

 

 

 

- - -

Vaccine Efficacy in IC Patients 

First or only episode of HZ – mTVC 

RZV Placebo 

VE 

(95% CI) 

Median 

follow up N n 

HZ Incidence Rate 

(per 1000 person years) N n 

HZ Incidence Rate 

(per 1000 person years) 

auHSCT1,2 870 49 30 851 135 94.3 68.2 

(55.6, 77.5) 

71.8 

(38.7, 88.3) 

67.3 

(52.6, 77.9) 

89.3 

(22.5, 99.8) 

87.2 

(44.3, 98.6) 

21 months 

18-49 213 9 21.5 212 29 76 

≥50 657 40 33 639 106 100.9 

PHN 870 1 0.5 851 9 4.9 

HM3* 259 2 8.5 256 14 66.2 11 months 

*Efficacy was evaluated in a post-hoc analysis. 

Each population was evaluated in a separate study. There are no head-to-head comparisons between immunocompromised populations. 

auHSCT, autologous hematopoietic stem cell transplant; CI, confidence interval; HM, hematologic malignancies; HZ, herpes zoster; IC, immunocompromised; mTVC, modified total 

vaccinated cohort; N, number of subjects included in each group; n, number of subjects having at least one confirmed HZ episode; VE, vaccine efficacy (Poisson method). 

1. Bastidas et al. JAMA. 2019; 322(2):123-133. 2. Data on File, ZOSTER-002 Clinical study report. Available on https://www.gsk-studyregister.com/study/115523 3. Dagnew AF, et al. 

Lancet Infect Dis. 2019;19(9):988-1000. 15 
-

-

-

-

-

Vaccine Immunogenicity 

1. Bastidas, et al. JAMA. 2019;322(2):123 133. 

2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988 1000. 

3. Vink P, et al. Cancer. 2019;125(8):1301 1312. 

4. Vink P, et al. Clin Infect Dis. 2020;70(2):181 190. 

5. Cunningham AL, et al. J Infect Dis. 2018;217(11):1750 1760 
 

 

 

 

 

 

RZV Multicenter Studies in IC Populations Were 

Randomized, Observer-blinded, Placebo-controlled 

IC population ≥18 YOA

Randomization 1:1 (RZV:Placebo) Only for 

M0 M1 M2 M7 M13 M25 

auHSCT1 HM2 RT3 ST4 

RZV; Placebo; blood sampling for humoral immunogenicity; blood sampling for cell-mediated immunity 

AE, adverse event; auHSCT, autologous hematopoietic stem cell transplant; HM, hematologic malignancies, HZ, herpes zoster; IC, immunocompromised; M, month; pIMD, potential 

immune-mediated disease; RT, renal transplant; RZV, recombinant zoster vaccine; SAE, serious adverse event; ST, solid tumor; YOA, years of age. 

1. Data on File, ZOSTER-002 Clinical study report. Available on https://www.gsk-studyregister.com/study/115523 2. Data on File, ZOSTER-039 Clinical study report. Available on

https://www.gsk-studyregister.com/study/116428 3. Data on File, ZOSTER-041 Clinical study report. Available on https://www.gsk-studyregister.com/study/116886 4. Data on File,

ZOSTER-028 Clinical study report. Available on https://www.gsk-studyregister.com/study/116427 17 
 

 

 

 

 

RZV Humoral Mediated Immunity 

Anti-gE GMCs (ELISA) Pre-, 1 month post dose 2, and 12 months post last dose – ATP 

cohort for immunogenicity 

763 

979 1050 

1354 1247 

12753 13371 

18292 19164 

52377 

3184 5203 

4477 

8545 

17726 

100 

1000 

10000 

100000 

Anti-gE GMC (mIU/mL) 

Pre 1 Month Post-Dose 2 12 Months Post-last dose 

N= 82 82 54 217 217 167 87 87 68 121 121 111 1069 1070 1037

1 2 3 4 5,6 auHSCT HM ST RT ZOE-50 

Error bars represent 95% CI. Each population was evaluated in a separate study. There are no head-to-head comparisons between immunocompromised populations. 

auHSCT, autologous hematopoietic stem cell transplant; ATP, according to protocol; gE, glycoprotein E; GMC, geometric mean concentration; HM, hematologic malignancies; RT, renal 

transplant; RZV, recombinant zoster vaccine; ST, solid tumor; ZOE-50, Zoster Older adults Efficacy trial in ≥50 years of age.

1. Bastidas, et al. JAMA. 2019;322(2):123-133. 2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988-1000. 3. Vink P, et al. Cancer. 2019;125(8):1301-1312. 4. Vink P, et al. Clin Infect

Dis. 2020;70(2):181-190. 5. Cunningham AL, et al. J Infect Dis. 2018;217(11):1750-1760. 6. Data on File, Study 110390 (ZOE-50) Clinical study report. Available on https://www.gskstudyregister.com/study/110390. 18 
 

RZV Cellular Mediated Immunity 

Median Frequency for gE-specific CD4+ T-cells Pre-, 1 Month post dose 2, and 

12 Months post last dose – ATP cohort for immunogenicity 

Pre 1 Month Post-Dose 2 12 Months Post-last dose 

49 78 127 

21 

90 

6,645 

3,082 

779 

2,149 1,844 

1,706 

1,007 

333 

1,066 800 

10 

100 

1000 

10000 

100000 

Frequency of gE-specific CD4+

T-cells (median ± IQR)

N= 47 51 32 52 53 44 25 22 18 31 32 33 174 164 169

 

 

 

 

 

 

1 2 3 4 5,6 auHSCT HM ST * RT ZOE-50 

Error bars represent 1st and 3rd IQR. Each population was evaluated in a separate study. There are no head-to-head comparisons between immunocompromised populations. 

*For ST study: on-chemo group (1st dose administered 8-30 days before chemotherapy and 2nd dose on the day of chemotherapy).

auHSCT, autologous hematopoietic stem cell transplant; ATP, according to protocol; gE, glycoprotein E; IQR, interquartile range; HM, hematologic malignancies; RT, renal transplant;

RZV, recombinant zoster vaccine; ST, solid tumor; ZOE-50, Zoster Older adults Efficacy trial in ≥50 years of age.

1. Bastidas, et al. JAMA. 2019;322(2):123-133. 2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988-1000. 3. Vink P, et al. Cancer. 2019;125(8):1301-1312.

4. Vink P, et al. Clin Infect Dis. 2020;70(2):181-190. 5. Cunningham AL, et al. J Infect Dis. 2018;217(11):1750-1760. 6. Data on File, Study 110390 (ZOE-50) Clinical study report.

Available on https://www.gsk-studyregister.com/study/110390 19 
 

 

 

 

 

 

 

 

 

Addressing the Unmet Need 

RZV Clinical Development Program in IC Patients 

auHSCT1 HM2 ST3 RT4 

–

–

–

–

Reactogenicity profile is expected based on clinical experience and nature of underlying conditions 

AEs, SAEs, pIMDs, relapses, disease progressions, and allograft rejections were balanced between the 

RZV and placebo groups 

Efficacy demonstrated in 2 populations: 68.2% (95% CI: 55.6-77.5) in auHSCT recipients and 87.2% 

(95% CI: 44.3-98.6) in HM* patients 

RZV is immunogenic even considering the impact of age, underlying disease, immunosuppressive 

treatment and immunization either before, during or after immunosuppressive treatments 

RZV immunogenicity and safety data support a favorable benefit -risk profile 

in IC adults ≥18 YOA, who are at an increased risk of HZ

*Efficacy was evaluated in a post-hoc analysis. 

Each population was evaluated in a separate study. There are no head-to-head comparisons between immunocompromised populations. 

AE, adverse event; auHSCT, autologous hematopoietic stem cell transplant; HM, hematologic malignancies; HZ< herpes zoster; IC, immunocompromised; pIMD, potential immune-mediated disease; 

RT, renal transplant; RZV, recombinant zoster vaccine; SAE, serious adverse event; ST, solid tumor; YOA, years of age. 

1. Bastidas, et al. JAMA. 2019;322(2):123-133. 2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988-1000. 3. Vink P, et al. Cancer. 2019;125(8):1301-1312. 4. Vink P, et al. Clin Infect Dis. 

2020;70(2):181-190. 20 
 

 

 

 

 

 

 

Addressing the Unmet Need 

Addressing the Unmet Need in IC Adults (≥18 YOA)1-6 

–

–

IC populations are very heterogeneous, both across and within groups 

Not feasible to define every possible IC condition/medication combination 

• Immune-compromising conditions 

• Comorbid conditions 

• Autoimmune conditions 

• Immunosuppressive therapies 

HIV 

auHSCT ST* 

HM RT

auHSCT 

Age 

IS therapy 

Timing 

of Vacc. 

UndUnderl erlyinyging Disease

Disease 

*Phase II/III study 

IC, immunocompromised; IS, immunosuppressive; RZV, recombinant zoster vaccine; Vacc, vaccination; YOA, years of age. 

1. Bastidas, et al. JAMA. 2019;322(2):123-133. 2. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988-1000. 3. Vink P, et al. Cancer. 2019;125(8):1301-1312. 4. Vink P, et al. Clin Infect 

Dis. 2020;70(2):181-190. 5. Berkowitz EM, et al. J Infect Dis. 2015;211(8):1279-1287. 6. Stadtmauer EA, et al. Blood. 2014;124(19):2921-2929. 21 
Thank You