COVID-19 Booster Vaccination in Persons With Multiple Sclerosis

NCT05081271 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 2021-12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The success of the U.S. vaccination program against SARS-Cov-2 is shown by a dramatic drop in infection rates, hospitalizations and deaths.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 proteins in response to vaccination. This group includes a significant number of persons with multiple sclerosis (PWMS), many of whom are on therapies that chronically suppress their immune function. It is unclear what advice clinicians should provide regarding COVID-19 precautions to patients who fail to develop detectable COVID-19 spike protein antibodies using standard commercially-available tests after a standard series of vaccination, or whether they should test for antibody responses to COVID-19 vaccines in the absence of guidelines. A key research question is whether, in the absence of stopping or reducing potentially immune-altering therapies, there is a way to increase the likelihood of a neutralizing antibody response to COVID-19 vaccination in PWMS who are taking immune suppressive medications.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; MS

Outcome Measures

Primary Outcomes (1)

• Percent who test positive for COVID-19 spike protein antibodies following booster

  Percentage of subjects who test positive for COVID-19 spike protein antibodies following a booster vaccination.

  4-6 weeks

Secondary Outcomes (3)

• Comparison of COVID-19 spike protein antibodies based on booster received

  4-6 weeks

• Comparison of COVID-19 spike protein antibodies based on disease-modifying treatment

  4-6 weeks

• Correlation of COVID-19 spike protein antibodies with B and T cell levels and immunoglobulins

  4-6 weeks

Study Arms (2)

Homologous booster vaccine group

ACTIVE COMPARATOR

A single dose booster of the same type of COVID-19 vaccine (i.e., mRNA or DNA) that the study participant received as part of an initial vaccine series prior to enrolling in this study.

Biological: Homologous booster

Heterologous booster vaccine group

ACTIVE COMPARATOR

A single dose booster of the opposite type of COVID-19 vaccine (i.e., mRNA or DNA) that the study participant received as part of an initial vaccine series prior to enrolling in this study.

Biological: Heterologous booster

Interventions

Homologous booster BIOLOGICAL

Group 1 will receive a booster dose of a homologous vaccine and Group 2 a heterologous vaccine. This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa

Homologous booster vaccine group

Heterologous booster BIOLOGICAL

Group 1 will receive a booster dose of a homologous vaccine and Group 2 a heterologous vaccine. This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa

Heterologous booster vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically definite multiple sclerosis (CDMS) by the 2017 McDonald Criteria 38;
• Age greater than or equal to 18 years;
• Ability to travel to Griffin Hospital for phlebotomy and booster vaccination;
• Completion of an initial COVID-19 vaccine series at least 4 weeks prior to booster randomization (i.e., two doses of either BNT162b2 or mRNA-1273, or one dose of Ad26.COV2.S);
• Prior negative test for COVID-19 spike protein antibodies using a commercial assay;
• Willing to undergo a booster vaccination with either BNT162b2, mRNA-1273 or Ad26.COV2.S.

You may not qualify if:

• Inability to give consent;
• Non-fluency in English;
• Inability to adhere to the protocol;
• Anticipated life expectancy of less than six months;
• Lack of a primary care physician or treating neurologist;
• Taking an immunosuppressive medication or chemotherapy for any other conditions aside fromMS;
• Presence of another autoimmune condition requiring treatment;
• Active treatment for cancer;
• History of heavy alcohol use within the past year, as defined by the following criteria:
• Men: 5 or more alcoholic beverages per session or per day, or 15 or more per week;
• Women: 4 or more alcoholic beverages per session or per day, or 8 or more per week;
• History of illicit drug abuse, e.g., cocaine, heroin, PCP, and/or narcotics within the past year;
• Any condition that would jeopardize the safety or rights of the subject, make it unlikely for the subject to complete the study, or confound the study results.
• Anaphylactic or other severe reaction to a previously administered COVID-19 vaccine;
• MS relapse or worsening symptoms after initial COVID-19 vaccination.

Sponsors & Collaborators

• Griffin Hospital: lead
• Yale-Griffin Prevention Research Center: collaborator
• Multiple Sclerosis Treatment Center: collaborator

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joseph B Guarnaccia, MD

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

• Frederick Browne, MD

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study. No masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed pilot study is a prospective, randomized open label study with two treatment assignments: one group will receive a homologous booster vaccine and the other a heterologous booster vaccine.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 18, 2021
• Study Start: October 15, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be shared upon request following publication of our findings.
• Access Criteria: The study PI will review and address requests for IPD.

Locations

US (1)