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Clinical Investigations

The IHB Clinical Investigations Office conducts clinical studies dedicated to understanding diversity in immune responses to vaccines when delivered to large populations, and the impact of this diversity on efficacy and safety. These studies hold enormous potential for improving the quality of care and reducing the rate and severity of adverse events following immunization. Through these projects, we also hope to improve the quality of life for those who are adversely impacted by immunizations, reduce healthcare costs and disease rates through increased vaccination rates, and increase the acceptability of vaccine programs.

The Clinical Investigations Office collaborates with other military, government, and academic research organizations to develop and implement vaccine clinical research projects considered essential to national and military safety and defense. We are currently enrolling subjects in several studies.

Reducing Pain following Immunization Study

Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After Inoculation:  the NEED LESS PAIN Study

Currently seeking study volunteers during the Annual Influenza Vaccination season. For more information, please Email Us

Study Description

This study aims to learn about vaccination site pain and the effect of exercise or the use of medication to treat pain associated with flu vaccination.  The study is also evaluating whether NSAIDs alter the immune response to the flu vaccine.

Eligibility

We are enrolling active duty service members who are about to receive their annual flu vaccination.  The flu vaccination will be given by the research team member.

Currently enrolling at the following Regional Vaccine Safety Hubs (RVSHs):

  • National Capital Region RVSH at Walter Reed National Military Medical Center (WRNMMC), Bethesda, Maryland
  • Fort Bragg RVSH, Fort Bragg, North Carolina

Study Assessments

Questionnaires and two blood draws; diary card for recording any symptoms daily.

Duration of Participation

Three visits to WRNMMC or WAMC over a one-month period.

Anthrax Vaccine Immunogenetics Study

Molecular and Immunologic Analysis of Anthrax Vaccine Immune Responses in the Context of Adverse Events

Currently seeking study volunteers. For more information, please Email Us

Study Description

This study, conducted in collaboration with the Oklahoma Medical Research Foundation, aims to improve the understanding of differences in immune responses to the anthrax vaccine, evaluating both the quantity and quality of antibodies produced.

Eligibility

We are currently enrolling individuals who experienced selected adverse reactions (e.g., new, lingering headaches, joint aches, muscle aches, and/or fatigue; large local reactions) following receipt of the vaccine. We also have a particular interest in female and Asian or African-American participants whether or not they experienced an adverse event.

All study participants must be eligible for care through the Military Health System.

Currently enrolling at the following Regional Vaccine Safety Hubs (RVSHs):

  • National Capital Region RVSH at Walter Reed National Military Medical Center (WRNMMC), Bethesda, Maryland
  • Fort Bragg RVSH, Fort Bragg, North Carolina

Study Assessments

Questionnaires and blood draw.

Duration of Participation

One visit to WRNMMC or WAMC; follow-up e-mail questionnaires.

Myocarditis/Pericarditis Following Vaccinations Study

Myocarditis/Pericarditis Following Smallpox Vaccine: Natural History Study

Currently seeking study volunteers. For more information, please Email Us.

Study Description

This study aims to document the long-term outcomes of myocarditis/pericarditis associated with the smallpox vaccine or any other vaccine.  It also seeks to describe the potential risk factors for developing myocarditis/pericarditis following the receipt of the smallpox vaccine.

Eligibility

We are currently enrolling individuals who experienced myocarditis/pericarditis following receipt of a vaccine. 

Enrollment Location(s)

  • Remote enrollment, via telephone or secure email
  • In-person enrollment at National Capital Region RVSH at Walter Reed National Military Medical Center (WRNMMC), Bethesda, Maryland

Study Assessments

Questionnaires, conducted in person, via telephone, or via email, over at least a 2-year period.

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

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