A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05127434

Collaborator

(none)

34,000

Enrollment

Locations

Arms

36.4

Anticipated Duration (Months)

485.7

Patients Per Site

13.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus	Drug: Placebo Drug: mRNA-1345	Phase 2/Phase 3

Detailed Description

The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Phase 2 segment, between 400 and 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Phase 3 segment, between 32,000 and 33,600 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

Actual Study Start Date :

Nov 17, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mRNA-1345 Single injection of mRNA-1345 on Day 1.	Drug: mRNA-1345 Sterile liquid for injection
Experimental: Placebo Single injection of mRNA-1345 matching-placebo on Day 1.	Drug: Placebo 0.9% sodium chloride (normal saline) injection

Arm

Intervention/Treatment

Experimental: mRNA-1345

Single injection of mRNA-1345 on Day 1.

Drug: mRNA-1345

Sterile liquid for injection

Experimental: Placebo

Single injection of mRNA-1345 matching-placebo on Day 1.

Drug: Placebo

0.9% sodium chloride (normal saline) injection

Outcome Measures

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) up to 7 Days Postinjection [Up to 7 days postinjection]
Number of Participants with Unsolicited Adverse Events (AEs) up to 28 Days Postinjection [Up to 28 days postinjection]
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal up to 24 Months Postinjection [Up to 24 months postinjection]
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD within the Period of 14 Days Postinjection up to 12 Months Postinjection [14 days postinjection up to 12 months postinjection]
VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100*(1-RR), where RR is the ratio of attack rates in the mRNA-1345 group and the placebo group.

Secondary Outcome Measures

VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD) within the Period of 14 Days Postinjection up to 12 Months Postinjection [14 days postinjection up to 12 months postinjection]
VE of mRNA-1345 to prevent RT-PCR confirmed protocol-defined RSV-ARD, defined as 100*(1-RR), where RR is the ratio of attack rates in the mRNA-1345 group and the placebo group.
VE of mRNA-1345 to Prevent Hospitalizations Associated with RSV-ARD or RSV-LRTD within the Period of 14 Days Postinjection up to 12 Months Postinjection [14 days postinjection up to 12 months postinjection]
VE of mRNA-1345 to prevent RT-PCR confirmed protocol-defined RSV-ARD or RSV-LRTD, defined as 100*(1-RR), where RR is the ratio of attack rates in the mRNA-1345 group and the placebo group.
Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs) [Baseline and 1, 6, 12, 18, and 24 months postinjection]
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers [Baseline and 1, 6, 12, 18, and 24 months postinjection]
Proportion of Participants with ≥4-fold Increases in Ab Titers from Baseline [Baseline and 1, 6, 12, 18, and 24 months postinjection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

Adults ≥ 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (specifically chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable as assessed by the following criteria: absence of changes in medical therapy within 1 month due to treatment failure or toxicity; absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1; and absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely.
Body mass index from ≥18 kilograms (kg)/square meter (m^{2) to ≤35 kg/m}2.

Key Exclusion Criteria:

Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.
Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).
History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection. The exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.

Other inclusion and/or exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accel Research Site - Achieve - Birmingham	Birmingham	Alabama	United States	35216
2	Desert Clinical Research, LLC - CCT	Mesa	Arizona	United States	85213
3	Tucson Neuroscience Research	Tucson	Arizona	United States	85710
4	Baptist Health Center for Clinical Research	Little Rock	Arkansas	United States	72205
5	Velocity Clinical Research, Banning	Banning	California	United States	92220
6	Hope Clinical Research, LLC	Canoga Park	California	United States	91303
7	Paradigm Research	La Mesa	California	United States	91942
8	Velocity Clinical Research, San Diego	La Mesa	California	United States	91942
9	Wr-Pri, Llc	Los Alamitos	California	United States	90720
10	Wr-Pri, Llc	Newport Beach	California	United States	92660
11	FOMAT Medical Research - FOMAT - HyperCore - PPDS	Oxnard	California	United States	93030
12	Reddy Care Medical	Pomona	California	United States	91768
13	Paradigm Clinical Research Institute Inc - ClinEdge - PPDS	Redding	California	United States	96001
14	Wr-McCr, Llc	San Diego	California	United States	92120
15	Lynn Institute of Denver	Aurora	Colorado	United States	80012
16	Tekton Research	Fort Collins	Colorado	United States	80525
17	Paradigm Clinical Research Institute Inc - ClinEdge - PPDS	Wheat Ridge	Colorado	United States	80033
18	Clinical Research Consultants LLC - ClinEdge - PPDS	Milford	Connecticut	United States	06460
19	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida	United States	32132
20	Fleming Island Clinical Research Center	Fleming Island	Florida	United States	32003
21	Jackonsville Center for Clinical Research	Jacksonville	Florida	United States	32216
22	ARS- Maitland	Maitland	Florida	United States	32751
23	Spotlight Research Center, LLC	Miami	Florida	United States	33176
24	Health Awareness Inc	Port Saint Lucie	Florida	United States	33458
25	Palm Beach Research - ClinEdge - PPDS	West Palm Beach	Florida	United States	33409
26	Clinical Site Partners - Winter Park - HyperCore -PPDS	Winter Park	Florida	United States	32789
27	IACT Health - Roswell - IACT - HyperCore - PPDS	Columbus	Georgia	United States	31904
28	iResearch Atlanta	Decatur	Georgia	United States	30030
29	Javara, Inc./Privia Medical Group Georgia, LLC	Fayetteville	Georgia	United States	30214
30	WR-Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia	United States	30328
31	Meridian Clinical Research- Savannah, GA	Savannah	Georgia	United States	31406
32	East West Medical Research Institute	Honolulu	Hawaii	United States	96814
33	Affinity Health (Oak Brook)	Oak Brook	Illinois	United States	60523
34	DM Clinical - Chicago	River Forest	Illinois	United States	60305
35	Meridian Clinical Research - Sioux City	Sioux City	Iowa	United States	51106
36	Johnson County Clin-Trials	Lenexa	Kansas	United States	66219
37	Benchmark Research - Covington - HyperCore - PPDS	Covington	Louisiana	United States	70433
38	Benchmark Research - Metairie - HyperCore - PPDS	Metairie	Louisiana	United States	70006
39	Clinical Trials of America (LA)	Monroe	Louisiana	United States	71259
40	Javara, Inc./Privia Medical Group, LLC	Annapolis	Maryland	United States	21401
41	Meridian Clinical Research- Rockville, MD	Rockville	Maryland	United States	20854
42	Skyline Medical Center, PC - CCT Research	Elkhorn	Nebraska	United States	68022
43	Meridian Clinical Research- Grand Island, NE	Grand Island	Nebraska	United States	68803
44	Meridian Clinical Research- Lincoln, NE	Lincoln	Nebraska	United States	68510
45	Meridian Clinical Research- Omaha, NE	Omaha	Nebraska	United States	68134
46	HEALOR Primary Care - Physicians Las Vegas - CCT	Las Vegas	Nevada	United States	89102
47	Meridian Clinical Research- Endwell, NY	Endwell	New York	United States	13760
48	Carolina Institute for Clinical Research	Fayetteville	North Carolina	United States	28303
49	Trial Management Associates, LLC	Wilmington	North Carolina	United States	28403
50	CTI Clinical Research	Cincinnati	Ohio	United States	45212
51	Meridian Clinical Research	Cincinnati	Ohio	United States	45219
52	Tekton Research	Edmond	Oklahoma	United States	73013
53	Tekton Research	Yukon	Oklahoma	United States	73099
54	Premier Family Physicians - Austin - Hunt - PPDS	Austin	Texas	United States	78735
55	Tekton Research	Austin	Texas	United States	78745
56	PanAmerican Clinical Research LLC	Brownsville	Texas	United States	78520
57	North Texas Family Medicine - Plano - Hunt - PPDS	Carrollton	Texas	United States	75010
58	Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas)	Fort Worth	Texas	United States	76132
59	Mt. Olympus Medical Research	Friendswood	Texas	United States	77546
60	West Houston Clinical Research - Hunt - PPDS	Houston	Texas	United States	77055
61	DM Clincial-TCDD	Houston	Texas	United States	77081
62	DM Clinical - Humble	Humble	Texas	United States	77338
63	ACRC Trials - Hunt - PPDS	Plano	Texas	United States	75024
64	AIM Trials	Plano	Texas	United States	75093
65	Clinical Trials of Texas, LLC - HyperCore - PPDS	San Antonio	Texas	United States	78229
66	DM Clinical - Tomball	Tomball	Texas	United States	77375
67	Olympus Family Medicine- CCT	Holladay	Utah	United States	84117
68	South Ogden Family Medicine - CCT	South Ogden	Utah	United States	84405
69	Health Research of Hampton Roads Inc. - BTC - PPDS	Newport News	Virginia	United States	23606
70	Meridian Clinical Research- Portsmouth, VA	Portsmouth	Virginia	United States	23703