Humoral immune responses associated with control of SARS-CoV-2 breakthrough infections in a vaccinated US military population.

Background: COVID-19 vaccines have been critical for protection against severe disease following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) but gaps remain in our understanding of the immune responses that contribute to controlling subclinical and mild infections.

Methods: Vaccinated, active-duty US military service members were enrolled in a non-interventional, minimal-risk, observational study starting in May, 2021. Clinical data, serum, and saliva samples were collected from study participants and were used to characterise the humoral immune responses to vaccination and to assess its impact on clinical and subclinical infections, as well as virologic outcomes of breakthrough infections (BTI) including viral load and infection duration.

Integrating Somatic and Germline Next-Generation Sequencing Into Routine Clinical Oncology Practice.

Next-generation sequencing (NGS) is rapidly expanding into routine oncology practice. Genetic variations in both the cancer and inherited genomes are informative for hereditary cancer risk, prognosis, and treatment strategies. Herein, we focus on the clinical perspective of integrating NGS results into patient care to assist with therapeutic decision making.

Gut Microbiota and Response to Immunotherapeutic Drugs in Oncology: More Questions Than Answers.

Immuno-oncology drugs (IODs) have revolutionized the treatment of some cancers. Although IODs are enabling some patients with cancer to become long-time survivors, only 30% to 40% respond to these drugs. There is experimental and clinical evidence that the gut microbiome may play a role in IOD response, leading to speculation that manipulation of the gut microenvironment might improve the response rate to IODs.

Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults.

Background: The fatal disease caused by Bacillus anthracis is preventable with a prophylactic vaccine. The currently available anthrax vaccine requires a lengthy immunization schedule, and simpler and more immunogenic options for protection against anthrax are a priority for development. In this report we describe a phase I clinical trial testing the safety and immunogenicity of an anthrax vaccine using recombinant Escherichia coli-derived, B.

Comparison of the urine Leukocyte Esterase Test to a Nucleic Acid Amplification Test for screening non-health care-seeking male soldiers for Chlamydia trachomatis and Neisseria gonorrhoeae infections.

We evaluated the Leukocyte Esterase Test (LET) as a screening tool by testing urine from 1,438 non-health care-seeking male Army basic trainees with LET and a Nucleic Acid Amplification Test. Compared to Nucleic Acid Amplification Test results, LET sensitivity and specificity for detection of chlamydia and gonorrhea were 45.8% and 97.

Patterns of antibody response in humans to the anthrax vaccine adsorbed (AVA) primary (six-dose) series.

The antibody profile during and after the six-dose primary vaccination series with anthrax vaccine adsorbed (AVA, Biothrax) was characterized in 86 human volunteers. Ninety-three percent of recipients developed IgG antibodies to Bacillus anthracis protective antigen (PA) after two doses, and 100% were seropositive after dose #3. Geometric mean concentrations (GMC) of IgG to PA measured before and after each dose were significantly lower after injection #3 (peak GMC=146.

Protective antigen and toxin neutralization antibody patterns in anthrax vaccinees undergoing serial plasmapheresis.

Recipients of licensed anthrax vaccine (AVA; Biothrax) could serve as a source of hyperimmune plasma and immunoglobulin for therapy and prophylaxis. We measured serum antibodies during serial weekly to biweekly plasmapheresis in 38 individuals previously vaccinated with 4 to 27 doses of AVA. Immunoglobulin G (IgG) to protective antigen (PA) and toxin neutralization assay (TNA) antibody levels were highly correlated (r = 0.

An assessment of health status among medical research volunteers who served in the Project Whitecoat program at Fort Detrick, Maryland.

Between 1954 and 1973, more than 2000 men entering military service as conscientious objectors participated in Project Whitecoat as medical research volunteers for the Army's biological warfare defense program. An assessment of self-reported, current health status among 358 "exposed" individuals and 164 unexposed control subjects found no conclusive evidence that receipt of investigational agents was related to adverse health outcomes. No differences in current overall health, current exercise levels, self-reported symptoms, and self-reported medical conditions were seen between the study groups.

Long-term health effects of repeated exposure to multiple vaccines.

The health of 155 former workers in a US military research program who had received multiple vaccines and 265 matched community controls was assessed. The study population was mostly male (83%) and elderly (median age, 69 years). Multiply immunized (MIP) subjects received vaccines and/or skin tests (median = 154) over a median of 17.

Feasibility and short-term impact of linked education and urine screening interventions for Chlamydia and gonorrhea in male army recruits.

Objective: The objective of this study was to assess the feasibility of an intervention for sexually transmitted diseases (STDs) and a screening program for Chlamydia trachomatis and Neisseria gonorrhoeae infections in male Army recruits.

Goals: The goals of this study were to identify and treat chlamydia and gonorrhea infections in recruits, assess their perceptions of risk, and increase their STD knowledge and behavioral intentions.

Study Design: Volunteers (n = 3911) entering basic training (July 1999-June 2000) at Fort Jackson, South Carolina, attended an educational intervention, completed pre- and post-questionnaires, and provided a urine specimen for chlamydia and gonorrhea screening by nucleic acid amplification testing.

Sustained high prevalence of Chlamydia trachomatis infections in female army recruits.

Background: Chlamydia trachomatis infections are prevalent among young sexually active females, have serious sequelae, and are mostly asymptomatic. Screening and treatment of infected females has been demonstrated to prevent sequelae such as pelvic inflammatory disease.

Goal: To assess prevalence and risk factors for chlamydia infection in US Army female recruits, whether these changed over time, and to examine variables contributing to any observed patterns.

Musculoskeletal injuries in an Army airborne population.

To maintain operational readiness, military personnel engage in vigorous physical and training activities that carry risk for injury. A 1-year prospective cohort study, starting April 1996, was conducted at Fort Bragg, North Carolina among 1,965 members of the 82nd Airborne Division to quantify musculoskeletal injuries. Information collected included type of injury, site, circumstances, and resultant limited duty days.

First case of bioterrorism-related inhalational anthrax, Florida, 2001: North Carolina investigation.

The index case of inhalational anthrax in October 2001 was in a man who lived and worked in Florida. However, during the 3 days before illness onset, the patient had traveled through North Carolina, raising the possibility that exposure to Bacillus anthracis spores could have occurred there. The rapid response in North Carolina included surveillance among hospital intensive-care units, microbiology laboratories, medical examiners, and veterinarians, and site investigations at locations visited by the index patient to identify the naturally occurring or bioterrorism-related source of his exposure.

Antibody response to a delayed booster dose of anthrax vaccine and botulinum toxoid.

We evaluated the prevalence and concentration of serum antibodies 18-24 months after primary inoculation with anthrax and botulinum vaccines, and assessed the reactogenicity and immunogenicity of a significantly delayed booster dose of these vaccines. Five hundred and eight male active-duty military personnel received one, two or three inoculations with anthrax vaccine and/or botulinum toxoid in 1990/1991 in preparation for Operations Desert Shield/Desert Storm. Subjects were vaccinated with the licensed anthrax vaccine, adsorbed (AVA) and pentavalent (ABCDE) botulinum toxoid (PBT) BB-IND 3723.

Evaluation of dry and wet transported intravaginal swabs in detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in female soldiers by PCR.

Screening women for sexually transmitted diseases (STD) in nonclinic settings is highly desirable because many infections are asymptomatic. This is especially true for military women, for whom logistical, social, and other job-related obstacles present barriers to accessing medical care. We assessed the accuracy of intravaginal swabs transported by mail in a wet versus a dry state for PCR (Amplicor CT/NG test) detection of chlamydia and gonorrhea infections in a cross-sectional study of 793 active-duty military women attending an STD clinic.

Hospitalization rates in female US Army recruits associated with a screening program for Chlamydia trachomatis.

Background: A volunteer program to test non-healthcare-seeking women for genital Chlamydia trachomatis infection was instituted at the US Army's largest basic training center and evaluated for its effectiveness in reducing sequelae.

Goal: To compare hospitalization rates between women with positive test results for C trachomatis and those with negative results, and between women tested and those not tested for C trachomatis.

Study Design: For this study, 28,074 women who entered the Army in 1996 and 1997 were followed for hospitalizations through December 1998.