A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults
Experimental: Part A: mRNA-1195.1 Dose Level 1

Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.

Biological: mRNA-1195.1

Sterile liquid for injection

Experimental: Part A: mRNA-1195.2 Dose Level 1

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Sterile liquid for injection

Experimental: Part A: mRNA-1195.1 Dose Level 2

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.

Biological: mRNA-1195.1

Sterile liquid for injection

Experimental: Part A: mRNA-1195.2 Dose Level 2

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Sterile liquid for injection

Experimental: Part A: mRNA-1195.1 Dose Level 3

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.

Biological: mRNA-1195.1

Sterile liquid for injection

Experimental: Part A: mRNA-1195.2 Dose Level 3

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Sterile liquid for injection

Experimental: Part A: mRNA-1195.1 Dose Level 4

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.

Biological: mRNA-1195.1

Sterile liquid for injection

Experimental: Part A: mRNA-1195.2 Dose Level 4

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.

Biological: mRNA-1195.2

Sterile liquid for injection

Active Comparator: Part A: mRNA-1189

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Biological: mRNA-1189

Sterile liquid for injection

Placebo Comparator: Part A: Placebo

Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

Biological: Placebo

0.9% sodium chloride (normal saline) injection

Experimental: Part B: mRNA-1195.1 or mRNA-1195.2 Low Dose

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.

Biological: mRNA-1195.1

Sterile liquid for injection

Biological: mRNA-1195.2

Sterile liquid for injection

Experimental: Part B: mRNA-1195.1 or mRNA-1195.2 Middle Dose

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.

Biological: mRNA-1195.1

Sterile liquid for injection

Biological: mRNA-1195.2

Sterile liquid for injection

Experimental: Part B: mRNA-1195.1 or mRNA-1195.2 High Dose

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.

Biological: mRNA-1195.1

Sterile liquid for injection

Biological: mRNA-1195.2

Sterile liquid for injection

Active Comparator: Part B: mRNA-1189

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Biological: mRNA-1189

Sterile liquid for injection

Placebo Comparator: Part B: Placebo

Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

Biological: Placebo

0.9% sodium chloride (normal saline) injection

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

April 27, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
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