Augmentation of Immune Response to COVID-19 mRNA Vaccination Through OMT With Lymphatic Pumps

Covid19 Clinical Trial

Official title:

Augmentation of Immune Response to COVID-19 mRNA Vaccination Through Osteopathic Manipulative Treatment Including Lymphatic Pumps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928456
• Other study ID #: FB21/IRB026
• Status: Completed
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: April 2024
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Osteopathic Manipulative Treatment (OMT)
Osteopathic Manipulative Treatment (OMT) involves a number of hands-on techniques that are meant to address somatic dysfunction in the body as a part of the osteopathic approach to treating patients. There will be five techniques in total used in the study treatment plan.

Locations

Country	Name	City	State
United States	Western University of Health Sciences	Pomona	California

Sponsors (5)

Lead Sponsor	Collaborator
Western University of Health Sciences	American College of Osteopathic Physicians, American Osteopathic Foundation, Osteopathic Physicians and Surgeons of California, Xavier-Nichols Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgM antibody titer levels Percentage Change.	Percentage change from baseline in IgM assay levels of pre-vaccination titer vs IgM assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).	At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
Primary	IgG antibody titer levels Percentage Change	Percentage change from baseline in IgG assay levels of pre-vaccination titer vs IgG assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).	At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
Primary	IgM and IgG antibody titer duration	Time in days in which levels of IgM and IgG assay remain above detectable levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT) after vaccination.	At 3 months, 6 months and 1 year post- vaccination.
Secondary	Medication Usage	Assessment of medications that subjects used to negate side effects using a medication log.	Through study completion, an average of 1 year
Secondary	Adverse Effects/Side Effects	Reported side effects from the vaccines or adverse effects experienced from OMT.	Through study completion, an average of 1 year