ABSTRACT
BACKGROUND: Herpes zoster (HZ) is caused by varicella-zoster virus ( VZV ) reactivation. In the United States, Zoster vaccine (ZOSTAVAX) is indicated for HZ prevention in patients ≥50 years. AIMS: To evaluate the immunogenicity, safety, and tolerability of ZOSTAVAX in healthy Indian subjects, to support its registration in India. METHODS: This open-label, single-arm study was conducted at 10 sites in India. Healthy Indians (≥50 years) received a single ZOSTAVAX dose. Immunogenicity was assessed by VZV-specific antibody titer using gpELISA assay. VZV-specific antibody geometric mean titers (GMT; Day 1 pre-vaccination, Week 6 post-vaccination) and geometric mean fold-rise (GMFR; Week 6 post-vaccination) were assessed. Safety was evaluated by the incidence of adverse events (AEs) and serious adverse events (SAEs) within 42 days of vaccination. Two-sided 95% confidence intervals (CIs) were evaluated using t-distribution with natural log-transformed values. RESULTS: Of the 250 subjects (mean age, 58.6 years) enrolled and vaccinated, 244 subjects completed the 6-week follow-up. Overall, subjects in the per-protocol population had GMT of 149.8 gpELISA units/mL (n=250; 95% CI: 132.6, 169.2) at Day 1 pre-vaccination, and 410.8 gpELISA units/mL (n=243; 95% CI: 373.0, 452.6) at Week 6 post-vaccination. GMFR of VZV-specific antibody from Day 1 pre-vaccination to Week 6 post-vaccination was 2.8 (95% CI: 2.5, 3.1). Overall, 67 subjects (26.8%) experienced AEs, with 48 (19.2%) reporting injection-site AEs and 38 (15.2%) reporting non-injection-site AEs. SAE-abdominal pain and bronchitis-was reported in one (0.4%) patient each. There was one death, which was unrelated to the vaccine. LIMITATIONS: Since ZOSTAVAX introduces a new live attenuated virus, clinical reactivation of ZOSTAVAX virus and wild-type VZV will need to be differentiated. CONCLUSIONS: In healthy Indians ≥50 years, ZOSTAVAX was well tolerated and resulted in expected VZV-specific antibody titer levels at 6 weeks post-vaccination.
Subject(s)
Herpes Zoster Vaccine , Herpes Zoster , Adult , Antibodies, Viral , Herpesvirus 3, Human , Humans , India , Middle AgedABSTRACT
Previously considered a disease of childhood, pertussis is now also recognized as a significant problem for adolescents and adults; however, diagnosing pertussis remains problematic due to its nonspecific clinical presentation and the time delay, sensitivity/specificity, and expense of testing. To be effective, therapy is best started very early in the illness, when the illness is seldom recognized. Other than chemoprophylaxis in families with a non-immune infant, antibiotic therapy is controversial due to the ubiquitous nature of pertussis, its similarity to other respiratory infections, increased prevalence, prolonged outbreaks, and difficulties in determining true exposures in the general community. If antimicrobial therapy is used extensively for whooping cough prevention, drug reactions and increased bacterial resistance are expected. Likewise, without laboratory confirmation of infection, isolation of individuals is difficult and expensive. Fortunately, 2 new Food and Drug Administration-approved vaccines, 1 for adolescents and 1 for adolescents/adults, are now available. Both have been shown to be safe and to produce protective antibody responses. As vaccination of adolescent and adult groups is expanded, the rising incidence of pertussis in all age groups can be curtailed.
