Phase 2
N=120
Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00920218 ↗Enrolled (actual)
120
Serious AEs
27.5%
Results posted
Dec 2017
Primary outcome: Primary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms — 25; 19; 22; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Herpes Zoster Vaccine 1437173A (Biological); Placebo vaccine (saline) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
25; 19; 22; 4; 3; 0 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
13; 11; 12; 15; 7; 1 | — |
| PRIMARY Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) |
25; 23; 22; 16; 21; 5 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 9; 10; 8 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 9; 10; 8 | — |
| PRIMARY Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders |
0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders |
0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines |
116.53; 145.97; 83.15; 97.48; 856.69; 1376.95 | — |
| PRIMARY Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations |
29192.9; 22503.0; 11064.6; 406.0 | <0.0001 sig |
| PRIMARY Anti-gE Mean Antibody Concentrations |
683.78; 1366.94; 763.58; 1025.07; 4435.62; 3812.19 | — |
| SECONDARY Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens |
356.11; 449.31; 343.90; 273.91; 636.10; 1205.59 | — |
| SECONDARY Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines |
116.53; 145.97; 83.15; 97.48; 856.69; 1376.95 | — |
| SECONDARY Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations |
570.1; 755.1; 639.9; 659.2; 922.2; 1017.3 | — |
| SECONDARY VZV-specific Mean Antibody Concentrations |
968.22; 1340.29; 1304.22; 843.07; 1881.91; 1957.16 | — |
| SECONDARY Anti-gE Geometric Mean Antibody Concentrations |
531.2; 536.2; 448.0; 659.9; 1489.7; 1288.1 | — |
| SECONDARY Anti-gE Mean Antibody Concentrations |
683.78; 1366.94; 763.58; 1025.07; 4435.62; 3812.19 | — |
| SECONDARY Number of Subjects With Confirmed Herpes Zoster (HZ) Cases |
0; 2; 0; 2 | — |
Summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
- Male and female subjects at least 18 years old at the time of vaccination;
- Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;
- Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs
- Written informed consent obtained from the subject;
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria
- Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
- Administration of immunoglobulins since transplantation;
- Previous vaccination against varicella or HZ;
- History of HZ within the previous 12 months;
- Known exposure to VZV since transplantation;
- Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Hypersensitivity or intolerance to acyclovir or valacyclovir;
- Pregnant or lactating female.
Data sourced from ClinicalTrials.gov (NCT00920218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.