NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants with Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants with Solid Tumors on PD1/PDL1 Inhibitor Therapy, Including Booster Doses of Vaccine

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000115-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Pregnant Women;
Children

Special Instructions

Currently Not Provided

Keywords

mRNA-1273 vaccine;
moderna;
SARS-CoV-2;
booster shot

Recruitment Keyword(s)

None

Condition(s)

solid tumor malignancy;
hematologic malignancy;
Leukemia;
Lymphoma;
Multiple Myeloma

Investigational Drug(s)

2019-nCoV Vaccine (mRNA-1273)

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: mRNA-1273

Supporting Site

National Cancer Institute

Background:

COVID-19 is a viral infection. It has spread rapidly across the globe. It has overwhelmed health systems. Researchers are concerned that it may undo years of progress in the reduction of cancer-specific death. They want to test a vaccine that might protect people with cancer from COVID-19. The COVID-19 Vaccine from Moderna has obtained an emergency use authorization from the FDA. The vaccine has been proven to reduce infections with the virus that causes COVID-19, and it has already been given to millions of people around the world.

Objective:

To test the safety and efficacy of a vaccine using mRNA-1273 that may protect people with cancer from COVID-19.

Eligibility:

Adults ages 18 and older who have a solid tumor or blood cancer and who may benefit from a

vaccine that might prepare their immune system for fighting and preventing infection from COVID-19. Patients with solid tumors must be receiving treatment with an immunotherapy agent

Design:

Participants will be screened with a medical history, medicine review, and physical exam. They will have blood tests. They will have a pregnancy test if needed.

Participants will get 2 doses of the mRNA-1273 vaccine. It will be injected into a muscle in the arm on Days 1 and 29. Participants will have a follow-up phone call on Day 8 after the first dose. They will be followed for 12 months after the second dose.

Participants will have study visits at the Clinical Center on Days 1 and 29 to get the COVID-19 vaccine from Moderna. Patients will then be asked to come back for visits about 1 week and 1 month after the second dose. Patients will need to come back for visits 6 months and 1 year after the second vaccine dose to check to see how long the vaccine offers protection.

Some visits will last up to a few hours, but most will be significantly shorter.

Participants will give blood and saliva samples for research.

Participation will last about 13 months.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

Participants must meet all the inclusion criteria in order to be eligible to participate in the study.

Participants must have one of the following:

--Histologically or cytologically confirmed solid tumor receiving a standard of care PD1/PDL1 inhibitor for treatment of their solid tumor (inclusive of Hodgkin Lymphoma and Primary Mediastinal B-Cell Lymphoma patients receiving PD1/PDL1 inhibitors as standard of care therapy)

--Confirmed diagnosis of acute leukemia (myeloid (AML) or lymphoid (ALL) or other acute leukemia; multiple myeloma; Waldenstrom macroglobulinemia

--Confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia)

-Be post allogeneic stem cell transplantation (for any indication)

-Be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories

-Age >=18 years.

-History of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below:

--Absolute lymphocyte count-Grade 3 or lower, corresponding to a minimum value of 200 cells per mcL

--Absolute neutrophil count-Grade 3 or lower, corresponding to a minimum value of 500 cells per mcL

--Platelets-Grade 3 or lower, corresponding to a minimum value of 25,000 cells per mcL

--Total bilirubin-Grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal

--AST(SGOT)/ALT(SGPT)-Grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal

--Creatinine-Grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine

calculated clearance will be necessary, as below)

--Creatinine clearance (only necessary for patients with elevated creatinine)-For patients with Chronic Kidney Disease, a calculated

Glomerular Filtration Rate minimum will be required as follows: >30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.

-Participants with history of human immunodeficiency virus (HIV) may enroll

-Participants with history of chronic hepatitis B virus (HBV) must be on suppressive therapy (if indicated) with undetectable viral load.

-Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured with an undetectable HCV viral load. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

-A negative urine/serum pregnancy test for females of childbearing potential. The effects of mRNA-1273 Vaccine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment.

Note: A female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range).

Effective methods of contraception:

--Intrauterine device.

--Stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment.

---Hormonal contraceptive tablets.

---Injectable hormonal contraceptives.

---Implanted hormonal contraceptives.

---Cutaneous contraceptive patches.

---Intravaginal hormonal contraceptive rings.

At least 1 barrier method. Effective barrier methods for use in this study are:

--Male or female condom.

--Diaphragm.

--Creams or gels that contain a chemical to kill sperm

If a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception.

-Ability to understand and the willingness to sign a written informed consent document.

-CLL participants undergoing BTKi treatment interruption: Must be receiving treatment with a BTKi for (Bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

EXCLUSION CRITERIA:

All participants meeting any of the exclusion criteria at baseline will be excluded from study participation.

-Within 14 days of known exposure to someone with confirmed SARS CoV2 infection or COVID-19.

-Acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature greater than or equal to 38.0 degrees C/100.4 degrees F. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.

- Participants on the vaccine na(SqrRoot) ve arms cannot have received any doses of the COVID-19

vaccine.

Participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of Astra-Zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator.

Participants on the booster arms must have received all doses of their initial COVID-19 vaccine (Participants vaccinated with the Janssen vaccine must have received the single dose of that EUA vaccine for COVID19, but all others must have received 2 doses) at least 4 weeks prior to enrollment. Documentation will be required.

-Current treatment with investigational agents for prophylaxis against COVID-19.

-Known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled.

-Chronic cardiovascular disease that is not controlled.

-History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.

-Bleeding disorder considered a contraindication to intramuscular (IM) injection or phlebotomy.

-Participated in an interventional clinical trial with an investigational agent within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study. The site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred.

-Prior/Concomitant Therapy

--Has received prior radiotherapy within 14 days before the first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.

--Has received a live vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist (registered trademark)) are live attenuated vaccines and are not allowed.

--Has received an inactivated vaccine within 14 days before the first dose of study treatment.

-Have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. In all cases, the patient must be sufficiently recovered and stable before treatment administration.

--History of severe allergic reactions to any components of the study treatment.

--Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).

The following are exceptions to this criterion:

--Vitiligo or alopecia

--Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement

--Any chronic skin condition such as eczema or celiac disease that does not require systemic therapy

--Celiac disease controlled by diet alone.

--History of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis.

--Solid tumor participants with a history of leptomeningeal carcinomatosis.

-Has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.

-Active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).

-History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

-Has involvement in the planning and/or conduct of the study.

-Female who is pregnant or breastfeeding

-Male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Elad Sharon, M.D.
National Cancer Institute (NCI)



Marissa B. Mallek, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N254
10 Center Drive
Bethesda, Maryland 20892
(240) 760-7498
marissa.mallek@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04847050

--Back to Top--