Clinical trial NCT04928456: Augmentation of Immune Response to COVID-19 mRNA Vaccination Through OMT With Lymphatic Pumps
Official title: Augmentation of Immune Response to COVID-19 mRNA Vaccination Through Osteopathic Manipulative Treatment Including Lymphatic Pumps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID-19
OMT
Vaccination
Osteopathic manipulation
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
Collaborators: name: American College of Osteopathic Physicians
name: American Osteopathic Foundation
name: Osteopathic Physicians and Surgeons of California
name: Xavier-Nichols Foundation
First posted: 2021-06-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design of this study is a randomized, no-treatment control group, OMT intervention group with a parallel group design.
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of utilizing Osteopathic Manipulative Treatment (OMT) procedures as an addition to current mRNA COVID-19 vaccines in terms of enhancing the immune response of participants as assessed by looking for increased levels and duration of antibody titers.

Detailed description: The COVID-19 pandemic has taken many lives, caused millions to become ill, many hospitalized, it has wreaked havoc on our economy, our mental states, and many other aspects of our lives. Vaccines have provided the world with much needed relief against the pandemic but concerns of vaccine escape and naturally waning antibody titers remain in place. The emergence of new strains are a cause of concern. Standard vaccine protocol does not currently utilize the osteopathic medical approach. It has yet to be seen if OMT improves the immune system's response to the COVID-19 spike protein provided by vaccines. Prior research using OMT with lymphatic treatments has shown improved outcomes for hospitalized patients, patients with various diseases, and improved vaccine delivery for Hepatitis B vaccines. This randomized clinical trial will assess the effectiveness of the addition of OMT to COVID-19 vaccination procedures. Individuals will be recruited from those who present at the WesternU vaccine clinic for their first COVID-19 vaccination and from the incoming classes, current classes, faculty, and staff of the 9 colleges at the university. Volunteers will be consented to the study if they qualify and will be randomly assigned to either the control group who will only receive their vaccinations or into the OMT intervention group who will receive OMT provided by an osteopathic physician or an osteopathic OMM Teaching Fellow the day of each of their two vaccinations and the day following the two vaccinations.

Baseline blood samples will be taken for all subjects enrolled in the study. These baseline blood samples will be analyzed for IgG against nucleocapsid as a control to see if there was any previous infection since this would not be present in vaccinated individuals who had never been exposed and contracted COVID-19 and IgG against the spike protein which would help to track the immunity built up in response to the vaccine. Both groups will then receive their first vaccination and only the OMT intervention group will then undergo OMT after receiving their vaccine. The OMT group will return the next day to receive treatments for a second time. Both groups will have blood drawn for IgG vaccine titers against spike protein at 7 days, 21 days, 28 days, 35 days, 3 months, 6 months, and 12 months. Both groups will be asked to report any side effects and any medications used to combat these side effects throughout the entirety of the study. If a subject were to feel symptoms of COVID-19 during the study they would be asked to take a RT-PCR test so that the infection could be verified and tested for the strain type.

OMT modalities that will be used include myofascial release of the thoracic inlet, pectoral traction, diaphragm release with myofascial release, splenic pump, and thoracic pump. All techniques will be performed on the individuals with each technique lasting a total of 1 minute and the entire treatment lasting a total of 5 minutes.

The primary comparison will be the titer of antibodies at each point of each volunteer as expressed as a percentage of the base line pre-vaccination titer between the intervention group (receiving OMT) compared to the control group (not receiving OMT).

Eligibility criteria: Inclusion Criteria:

* Are between the ages of 18 and 65 years old
* Will be receiving the mRNA COVID-19 vaccine at Western University of Health Sciences
* Have signed an informed consent form
* Have not previously received a COVID-19 vaccine

Exclusion Criteria:

* Have contraindications to vaccine and any significant reactions to vaccines
* Have any primary or secondary immune deficiencies or autoimmune disease/immunocompromised
* Have symptoms of COVID-19 at the time of enrollment (eg. Fever, headaches, muscle pain, sore throat, coughing, loss of smell, loss of taste, etc.)
* Have already received a COVID-19 vaccine
* Are using any immune altering medications such as corticosteroids, cyclospoin, tacrolimus, and pimecrolimus
* Are unable to receive OMT with lymphatic techniques due to open wounds, fractures, anuresis, necrotizing faciitis, congestive heart failure, or unstable cardiac conditions
* Are pregnant or breastfeeding
* Are less than 18 years of age or more than 65 years of age
* Were previously treated for COVID-19 with serum transfer or immunological treatments
* Are on anti-coagulation therapy

Primary outcomes:
measure: IgM antibody titer levels Percentage Change.
timeFrame: At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
measure: IgG antibody titer levels Percentage Change
timeFrame: At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
measure: IgM and IgG antibody titer duration
timeFrame: At 3 months, 6 months and 1 year post- vaccination.
Secondary outcomes:
measure: Medication Usage
timeFrame: Through study completion, an average of 1 year
measure: Adverse Effects/Side Effects
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
Study officials:
affiliation: Professor of Family Medicine
name: Jesus Sanchez, DO
role: PRINCIPAL_INVESTIGATOR
References: