Clinical Investigations Division
Clinical Investigations Division

The MILVAX-VHCN 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

Fatigue Syndrome Study

Currently Seeking Volunteers

Study Title:

Complement Activation after Exercise: Markers of Prolonged Myalgia-Arthralgia-Fatigue Syndromes Post-Vaccine and in Patients with Obstructive Sleep Apnea

Study Description:

The main purpose of this study is to identify biological markers associated with symptoms of prolonged fatigue and pain. Specific immune response testing will be performed to determine why some individuals experience severe, disabling fatigue following exercise, while others feel energetic and refreshed after exercise. This study is being conducted in collaboration with the Walter Reed National Military Medical Center (WRNMMC) Critical Care and Sleep Medicine Service, Georgetown University, National Jewish Health, and Hyperion Biotechnology.

Eligibility:

We are enrolling participants in the following two groups:

  1. Individuals who experienced, within 45 days of immunization or an infection, symptoms which resulted in prolonged illness. These symptoms, which are made worse by exercise, include muscle pain, soreness, aching, or heaviness; soreness and/or aching within and/or around the joints; muscle spasms; unrefreshing sleep; and fatigue.
  2. Individuals recently diagnosed with Obstructive Sleep Apnea, prior to initiation of CPAP treatment.

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, exercise challenge, saliva collection and blood draws over a 3-day period

Duration of participation:

Eight short visits over three days to WRNMMC; annual follow-up email 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