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A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive

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ClinicalTrials.gov Identifier: NCT04528719
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of 1 of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Biological: mRNA-1345 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Arm Intervention/treatment
Experimental: Cohort 1: Dose A in Younger Adults
Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 2: Dose B in Younger Adults
Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 3: Dose B in Younger Adults
Three total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 4: Dose C in Younger Adults
Single injection of Dose C of mRNA-1345 or matching-placebo on Day 1.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 5: Dose D in Children
Three total injections, 1 injection of either Dose D of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 6: Dose B in Children
Three total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 7: Dose A in Older Adults
Two total injections, 1 injection of either Dose A of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 8: Dose B in Older Adults
Two total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 9: Dose C in Older Adults
Two total injections, 1 injection of either Dose C of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 10: Dose E in Older Adults
Two total injections, 1 injection of either Dose E of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 11: Dose F in Older Adults
Two total injections, 1 injection of either Dose F of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 12: Dose E in Women of Child-Bearing Potential
Single injection of Dose E of mRNA-1345 or matching-placebo on Day 1.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 13: Dose F in Women of Child-Bearing Potential
Single injection of Dose F of mRNA-1345 or matching-placebo on Day 1.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 14: Dose A in Women of Child-Bearing Potential
Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Cohort 15: Dose B in Japanese Older Adults
Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
Biological: mRNA-1345
Formulation for injection

Drug: Placebo
0.9% sodium chloride (normal saline) injection




Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 372 (7 days after each injection) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 393 (28 days after the last injection) ]
  3. Number of Participants with Serious AEs or Medically Attended AEs (MAAEs) [ Time Frame: Up to Day 730 (End of Study) ]

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs) [ Time Frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, and 14), up to Day 281 (Cohort 3), and up to Day 730 (Cohorts 7, 8, 9, 10, and 11) ]
  2. Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers [ Time Frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, and 14), up to Day 281 (Cohort 3), and up to Day 730 (Cohorts 7, 8, 9, 10, and 11) ]
  3. Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline [ Time Frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, and 14), up to Day 281 (Cohort 3), and up to Day 730 (Cohorts 7, 8, 9, 10, and 11) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 79 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Healthy young adults ≥18 to ≤49 years of age, women of child-bearing potential ≥18 to ≤40 years of age, healthy older adults ≥65 to <80 years of age, Japanese older adults ≥ 60 years of age, and children ≥12 to < 60 months of age.
  • Willing and physically able to comply with protocol-mandated follow-up, including all procedures.
  • Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol.

Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults [including Japanese older adults]):

  • Has a body mass index (BMI) from ≥18 kilogram (kg)/meter (m)^2 to ≤35 kg/m^2.
  • Female participants of non-child-bearing potential. This criterion does not apply for women of child-bearing potential Cohorts 12, 13, and 14.
  • Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of vaccination; 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination; 3) has agreed to continue adequate contraception through 3 months following the last injection; and 4) is not currently breastfeeding.

Specific inclusion criteria for children 12 to 59 months of age:

  • Seropositive for RSV-neutralizing Abs at Screening.
  • Has received routine immunizations appropriate for age per local guidance.
  • Current height and weight above the third percentile for age.

Specific inclusion criteria for Japanese older adults:

  • Adult Japanese participants ≥ 60 years of age at the time of consent, who in the opinion of the Investigator, are in good health based on review of medical history and screening physical examination.
  • Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.

Key Exclusion Criteria:

  • Has Screening laboratory values Grade ≥1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants).
  • Is acutely ill or febrile on the day of the first injection.
  • Has a significant medical history, including but not limited to:

    • Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection.
    • Chronic hepatitis or suspected active hepatitis.
    • Bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy.
    • Dermatologic conditions that could affect local solicited AR assessments.
    • Any history of allergic or anaphylactic reactions following a vaccination that required medical intervention.
    • Autoimmune disease except for Hashimoto's disease.
  • Receipt of:

    • Inactivated vaccine(s) within 14 days prior to first injection; or, plans to receive inactivated vaccine(s) within 14 days prior to and through 14 days following each study injection, with the exception of any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
    • Live virus vaccine(s) within 28 days prior to first injection; or, plans to receive live virus vaccine(s) within 28 days prior to and through 28 days following each study injection.
    • Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Inhaled, nasal, and topical steroids are allowed.
    • Intravenous blood products (red cells, platelets, and immunoglobulins [Ig]) within 3 months prior to enrollment.
  • Has received a drug product containing lipid nanoparticles (LNPs) within 14 days before enrollment, with the exception of any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.

Specific exclusion criteria for older adults:

  • Known history of poorly controlled hypertension (per determination of the Investigator) or systolic blood pressure >160 millimeters of mercury (mmHg) at the Screening visit.
  • Known history of hypotension or systolic blood pressure <85 mmHg at the Screening visit.
  • Poorly controlled diabetes mellitus (per determination of the Investigator).
  • Diagnosis of significant chronic pulmonary disease (per determination of the Investigator) (such as, chronic obstructive pulmonary disease, asthma).
  • Significant chronic cardiovascular disease (per determination of the Investigator).
  • Resides in a nursing home.
  • Anticipates the need for immunosuppressive treatment at any time during participation in the study.
  • Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer and cervical carcinoma in-situ).

Specific exclusion criteria for children 12 to 59 months of age:

  • Has received any monoclonal antibody at any time prior to Screening.
  • Prior hospitalization for RSV disease (confirmed by polymerase chain reaction).
  • Receipt of any prior systemic immunosuppressants or immune-modifying drugs.
  • Any history of febrile seizures (inclusive of single simple febrile seizure).
  • History of epilepsy.
  • History of meningitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528719


Contacts
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Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com

Locations
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Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04528719    
Other Study ID Numbers: mRNA-1345-P101
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Respiratory syncytial virus
RSV Seropositive
Safety
Pediatric
Vaccines
Additional relevant MeSH terms:
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Virus Diseases
Infections