Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects

Zika Virus Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of mRNA 1325 Zika Vaccine in Healthy Adults in a Non-endemic Zika Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014089
• Other study ID #: mRNA-1325-P101
• Secondary ID: HHSO100201600029
• Status: Completed
• Phase: Phase 1
• Start date: December 21, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion

• 18 to 49 years of age

• Body mass index between 18 and 35 kg/m2

• In good health as determined by medical history

• Female subjects must be non pregnant and non lactating and meet one of the following criteria: a) post menopausal b) surgically sterile

• Women of childbearing potential must agree to be heterosexually inactive or agree to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 3 months after the final vaccination

• Male subjects must use an acceptable method of birth control throughout the entire study and agree to refrain from donation of sperm from the time of first vaccination until 3 months following the last vaccination

• Agrees to comply with the study procedures and provides written informed consent

• Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study, to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study

Exclusion

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care

• A history of active cancer (malignancy) in the last 10 years

• Female of childbearing potential and has a positive pregnancy test at screening or on the day of vaccination

• Administration of an investigational product within 60 days, or 5 half-lives, whichever is longer

• Administration of any live attenuated vaccines within 4 weeks before enrollment or inactive vaccines within 2 weeks before enrollment, or plans to receive any vaccine during the active vaccination period

• Prior administration of a vaccine for Zika or dengue vaccine, a history of confirmed Zika or dengue infection, or has lived in or visited any Zika-endemic area greater than 4 weeks in duration

• Prior administration of investigational agent using formulations similar to mRNA-1325

• A history of hypersensitivity or serious reactions to previous vaccinations

• Any known or suspected autoimmune disease or immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination

• A history of inflammatory arthritis

• Any neurologic disorder

• A history of febrile disease with arthritis or arthralgia within 2 weeks of dose administration.

• Prior administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study drug or plans to receive such products at any time during the study

• Any chronic administration of an immunosuppressant or other immune modifying drug

• Any acute illness at the time of enrollment

• Any significant disorder of coagulation requiring ongoing or intermittent treatment

• A history of idiopathic urticaria

• A history of alcohol abuse or drug addiction

• A positive test result for drugs of abuse

• The subject has any abnormality or permanent body art (eg, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site

• Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled or could interfere with evaluation of the study drug or interpretation of study results

• A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies

• Donation of blood or blood products > 450 mL within 30 days of dosing.

• Abnormal vital signs or screening safety laboratory test results including liver enzyme tests

• Is an employee or first degree relative of the Sponsor, CRO, or study site personnel

Related Conditions & MeSH terms

• Zika Virus
• Zika Virus Infection

Intervention

Biological:
• mRNA-1325
Escalating dose levels

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ModernaTX, Inc.	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of Participants With Solicited Adverse Events- Vaccination 1	Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.	Up to 7 days post-vaccination 1 (up to 8 days)
Primary	Part A: Number of Participants With Solicited Adverse Events: Vaccination 2	Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.	Up to 7 days post-vaccination 2 (Day 29 to Day 36)
Primary	Part A: Number of Participants With Unsolicited Adverse Events	An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.	Up to 1 year post-vaccination (Day 392)
Primary	Part A: Number of Participants With Medically-Attended Adverse Events (MAAEs)	An MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.	Up to 1 year post-vaccination (Day 392)
Primary	Part B: Number of Participants With Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)	An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.	Up to 1 year post-vaccination (Day 392)
Secondary	Part A: Geometric Mean Titer of Neutralizing Serum Antibody (PRNT50) to Zika Virus	GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.	Baseline, 28 days post each vaccination (Days 29 and 57)