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1.
Vaccine ; 41(9): 1537-1540, 2023 02 24.
Article in English | MEDLINE | ID: mdl-36725428

ABSTRACT

Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC; Ixiaro) was approved in the United States in 2009. The previous JE vaccine, an inactivated mouse brain-derived vaccine, had been associated with rare, but serious, allergic and neurologic adverse events (AE). Studies and AE surveillance have supported JE-VC's safety, but one evaluation among military personnel found elevated hypersensitivity and neurologic AE rates. However, co-administration of multiple vaccines to some personnel might have affected results. We retrospectively compared rates of hypersensitivity and neurologic AEs within 28 days following vaccination of military personnel with JE-VC or parenteral Vi capsular polysaccharide typhoid vaccine administered without other vaccines from July 1, 2011, through August 31, 2019. Rates of most events were similar between the vaccines. Only delayed hypersensitivity reactions occurred more frequently following JE-VC (rate ratio: 4.2, 95 % CI 1.2-15.3; p = 0.03), but rates were low for both vaccines. These results support JE-VC's safety.


Subject(s)
Encephalitis, Japanese , Hypersensitivity , Japanese Encephalitis Vaccines , Military Personnel , Typhoid-Paratyphoid Vaccines , Animals , Chlorocebus aethiops , Mice , United States , Humans , Encephalitis, Japanese/prevention & control , Retrospective Studies , Vero Cells , Vaccines, Inactivated , Polysaccharides , Cell Culture Techniques
2.
Clin Infect Dis ; 73(11): e4312-e4320, 2021 12 06.
Article in English | MEDLINE | ID: mdl-32898271

ABSTRACT

BACKGROUND: Low vaccine effectiveness against A(H3N2) influenza in seasons with little antigenic drift has been attributed to substitutions in hemagglutinin (HA) acquired during vaccine virus propagation in eggs. Clinical trials comparing recombinant HA vaccine (rHA) and cell-derived inactivated influenza vaccine (IIV) to egg-derived IIVs provide opportunities to assess how egg-adaptive substitutions influence HA immunogenicity. METHODS: Neutralization titers in pre- and postimmunization sera from 133 adults immunized with 1 of 3 types of influenza vaccines in a randomized, open-label trial during the 2018-2019 influenza season were measured against egg- and cell-derived A/Singapore/INFIMH-16-0019/2016-like and circulating A(H3N2) influenza viruses using HA pseudoviruses. RESULTS: All vaccines elicited neutralizing antibodies to all H3 vaccine antigens, but the rHA vaccine elicited the highest titers and seroconversion rates against all strains tested. Egg- and cell-derived IIVs elicited responses similar to each other. Preimmunization titers against H3 HA pseudoviruses containing egg-adaptive substitutions T160K and L194P were high, but lower against H3 HA pseudoviruses without those substitutions. All vaccines boosted neutralization titers against HA pseudoviruses with egg-adaptive substitutions, but poorly neutralized wild-type 2019-2020 A/Kansas/14/2017 (H3N2) HA pseudoviruses. CONCLUSION: Egg- and cell-derived 2018-2019 season influenza vaccines elicited similar neutralization titers and response rates, indicating that the cell-derived vaccine did not improve immunogenicity against the A(H3N2) viruses. The higher responses after rHA vaccination may be due to its higher HA content. All vaccines boosted titers to HA with egg-adaptive substitutions, suggesting boosting from past antigens or better exposure of HA epitopes. Studies comparing immunogenicity and effectiveness of different influenza vaccines across many seasons are needed.


Subject(s)
Influenza Vaccines , Influenza, Human , Adult , Antibodies, Neutralizing , Antibodies, Viral , Hemagglutinin Glycoproteins, Influenza Virus/genetics , Hemagglutinins , Humans , Influenza A Virus, H3N2 Subtype , Seasons
3.
Vaccine ; 37(44): 6760-6767, 2019 10 16.
Article in English | MEDLINE | ID: mdl-31548014

ABSTRACT

BACKGROUND: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination. RESULTS: During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17-32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%). CONCLUSIONS: The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile.


Subject(s)
Adenoviridae Infections/prevention & control , Adenoviridae/classification , Adenoviridae/immunology , Adenovirus Vaccines/adverse effects , Adenovirus Vaccines/immunology , Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions/epidemiology , Adenovirus Vaccines/administration & dosage , Adolescent , Adult , Anaphylaxis/epidemiology , Anaphylaxis/prevention & control , Databases, Factual , Drug-Related Side Effects and Adverse Reactions/history , Female , History, 21st Century , Humans , Male , Pregnancy , Risk Assessment , Risk Factors , United States/epidemiology , Young Adult
4.
South Med J ; 108(3): 170-7, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25772051

ABSTRACT

OBJECTIVES: The southern region of the United States, particularly central and southern Appalachia, has long been identified as an area of health inequities. An updated and more complete understanding of the association among the leading risk factors for such health inequities allows researchers, clinicians, and policymakers to focus their efforts on the most effective strategies to minimize these risks. METHODS: Using the most recent survey data from the Behavioral Risk Factor Surveillance System, we examined 10-year trends in rates of cigarette smoking and obesity in Appalachian Kentucky, comparing these trends with national and non-Appalachian Kentucky rates. RESULTS: Women and men from Appalachian Kentucky smoke cigarettes at rates 1.8 times and 1.6 times higher, respectively, than their national counterparts. Although rates of smoking in Appalachian Kentucky, non-Appalachian Kentucky, and the United States have decreased, such decreases among Appalachian Kentucky women have been minimal. Adding to these concerning trends, obesity rates in Appalachian adults are much higher than in non-Appalachian Kentucky or the United States overall, although Appalachian Kentucky smokers are less likely to be obese than nonsmokers. Low socioeconomic status and impeded access to health care characterize the Appalachian communities in which these risk behaviors occur and likely account for the prevalence of these most risky behaviors. CONCLUSIONS: A continuum of approaches to address smoking and obesity is warranted. Such approaches range from ensuring access to smoking cessation programs to implementing community- and state-level policies to curb smoking and unhealthy energy balance (eg, smoke-free policies and increases in tobacco and "junk food" taxes) and culturally appropriate individual-level interventions (evidence-based smoking cessation and weight-loss programming).


Subject(s)
Health Status Disparities , Obesity/epidemiology , Rural Health/statistics & numerical data , Smoking/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Appalachian Region/epidemiology , Female , Health Surveys , Humans , Kentucky/epidemiology , Logistic Models , Male , Middle Aged , Obesity/etiology , Public Health Surveillance , Risk Factors , Young Adult
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