Clinical Investigations Division
Clinical Investigations Division

The IHB Clinical Investigations Division 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 Division 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 at Walter Reed National Military Medical Center, Bethesda, MD and Womack Army Medical Center, Fort Bragg, NC.

Anthrax Vaccine Immunogenetics Study

Currently Seeking Volunteers

Study Title:

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

Study Description:

This study, conducted in collaboration with the Oklahoma Medical Research Foundation, aims to improve the understanding of differences in immune responses to anthrax vaccine, evaluating both the quantity and quality of antibodies produced. Genetic testing will also be performed to determine if there are specific markers for (1) those who produce higher antibody responses to the vaccine, or (2) individuals who experience specific symptoms following receipt of the vaccine.

Eligibility:

We are currently enrolling individuals who experienced selected adverse events (e.g., new, lingering headaches, joint aches, muscle aches, and/or fatigue; large, local reactions) following receipt of the vaccine.

All study participants must be eligible for care through the military healthcare system.

Enrollment Locations:

Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD
Womack Army Medical Center (WAMC), Fort Bragg, NC

Study Assessments:

Questionnaires and blood draw

Duration of participation:

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

Principal Investigator:

Dr. Limone Collins, MD

For further information, please contact us at vhcresearch@med.navy.mil

Myopericarditis Following Vaccines: Natural History Study

Currently Seeking Volunteers

Study Title:

Myocarditis/Pericarditis Following Smallpox Vaccine: Natural History St

Study Description:

This study is designed to improve our understanding of the long-term outcomes of patients who developed myopericarditis following an immunization. The study may help identify potential risk factors for developing the reaction. Quality of life impact over time will be assessed, specifically as related to chest pain, energy, and physical fitness.

Eligibility:

We are remotely (via email and phone) enrolling individuals who developed new onset heart related symptoms after receiving vaccines.

All study participants must be eligible for care through the military healthcare system.

Enrollment Locations:

Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD

Study Assessments:

Questionnaires, No visits or blood draws

Duration of participation:

Email questionnaires periodically for at least 2 years

Principal Investigator:

Dr. Limone Collins, MD

For further information, please contact us at vhcresearch@med.navy.mil