Zika VirusPhase 1NCT03014089

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

A Phase 1 study testing mRNA-1325 in people with Zika Virus, run by ModernaTX, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Zika Virus
What is being tested?: mRNA-1325
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 3 sitesUnited States
Study dates: 21 Dec 2016to 31 Jul 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 25Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Melbourne, Florida, 32934
Study site
Peoria, Illinois, 61614
Study site
San Diego, California, 92108

Other trials in United States

About this study

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

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

Conditions: Zika Virus
Being tested: mRNA-1325, Placebo
Keywords: mRNA-1325, Zika vaccine
Medical subject headings: Zika Virus Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mRNA-1325Biological
Escalating dose levels
PlaceboOther

Study groups in NCT03014089
Study group	Role	What they receive
mRNA-1325	Experimental	Not described Receives: Biological: mRNA-1325
Placebo	Placebo comparator	0.9% sodium chloride Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 7 days post-vaccination 1 (up to 8 days)
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.
Measured: Up to 7 days post-vaccination 2 (Day 29 to Day 36)
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.
Measured: Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)
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.
Measured: Up to 1 year post-vaccination (Day 392)
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.
Measured: Up to 1 year post-vaccination (Day 392)

Secondary outcomes (1)

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.
Measured: Baseline, 28 days post each vaccination (Days 29 and 57)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 201631 Jul 2019

First posted9 Jan 2017 (estimated)
Study start21 Dec 2016
Primary completion31 Jul 2019
Study completion31 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Zika VirusStudies of the same condition, open and under way.
More trials run by ModernaTX, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03014089
Sponsor's protocol ID: mRNA-1325-P101
Other IDs: HHSO100201600029C
Status last verified: Jul 2024
First submitted: 5 Jan 2017
Last updated: 21 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Essink B, Chu L, Seger W, Barranco E, Le Cam N, Bennett H, Faughnan V, Pajon R, Paila YD, Bollman B, Wang S, Dooley J, Kalidindi S, Leav B. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023 May;23(5):621-633. doi: 10.1016/S1473-3099(22)00764-2. Epub 2023 Jan 19.
PubMed 36682364

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Malaria Fever, Zika
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All Zika Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03014089
Acronym / sponsor ID: mRNA-1325-P101
Conditions: Zika Virus
Keywords: mRNA-1325, Zika vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: ModernaTX, Inc.Industry (pharma, biotech, devices)
Collaborators: Biomedical Advanced Research and Development Authority
Study start: 21 Dec 2016 (actual)
Primary completion: 31 Jul 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 9 Jan 2017 (estimated)
Results: Posted 17 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
mRNA-1325	Experimental	Biological: mRNA-1325
Placebo	Placebo comparator	Other: Placebo0.9% sodium chloride

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (25 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mRNA-1325Escalating dose levels	Biological	mRNA-1325
Placebo	Other	Placebo

Primary outcome

Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Time frame: Up to 7 days post-vaccination 1 (up to 8 days)
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.
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Time frame: Up to 7 days post-vaccination 2 (Day 29 to Day 36)
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.
Part A: Number of Participants With Unsolicited Adverse Events
Time frame: Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)
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.
Part A: Number of Participants With Medically-Attended Adverse Events (MAAEs)
Time frame: Up to 1 year post-vaccination (Day 392)
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.
Part B: Number of Participants With Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Time frame: Up to 1 year post-vaccination (Day 392)
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.

1 secondary outcome

Part A: Geometric Mean Titer of Neutralizing Serum Antibody (PRNT50) to Zika Virus
Time frame: Baseline, 28 days post each vaccination (Days 29 and 57)

Results and safety

Results posted to the registry on 17 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mRNA-1325 10 mcg	25	23
mRNA-1325 25 mcg	24	23
mRNA-1325 100 mcg	25	23
Placebo	16	15

Primary outcome: Part A: Number of Participants With Solicited Adverse Events- Vaccination 1

Time frame: Up to 7 days post-vaccination 1 (up to 8 days). Count of participants. Unit: Participants

Measure	mRNA-1325 10 mcg n = 25	mRNA-1325 25 mcg n = 24	mRNA-1325 100 mcg n = 25	Placebo n = 16
Local Event- Pain	17	20	24	0
Local Event- Tenderness	21	20	23	3
Local Event- Swelling	0	1	1	0
Local Event- Redness	0	0	1	0
Systemic Event- Fever	0	0	2	1
Systemic Event- Vomiting	3	0	2	0
Systemic Event- Diarrhea	2	0	0	0
Systemic Event- Headache	11	4	10	3

Population analysed: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo) and provided vaccination 1 safety data.

Primary outcome: Part A: Number of Participants With Solicited Adverse Events: Vaccination 2

Time frame: Up to 7 days post-vaccination 2 (Day 29 to Day 36). Count of participants. Unit: Participants

Measure	mRNA-1325 10 mcg n = 25	mRNA-1325 25 mcg n = 24	mRNA-1325 100 mcg n = 24	Placebo n = 16
Local Event- Pain	19	19	19	1
Local Event- Tenderness	22	19	20	0
Local Event- Swelling	0	0	1	0
Local Event- Redness	1	0	2	0
Systemic Event- Fever	1	2	7	0
Systemic Event- Vomiting	4	4	7	0
Systemic Event- Diarrhea	2	0	1	0
Systemic Event- Headache	9	11	10	2

Population analysed: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo) and provided post vaccination 2 safety data.

Primary outcome: Part A: Number of Participants With Unsolicited Adverse Events

Time frame: Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57). Count of participants. Unit: Participants

Measure	mRNA-1325 10 mcg n = 25	mRNA-1325 25 mcg n = 24	mRNA-1325 100 mcg n = 25	Placebo n = 16
Value	14	9	14	6

Population analysed: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo).

Primary outcome: Part A: Number of Participants With Medically-Attended Adverse Events (MAAEs)

Time frame: Up to 1 year post-vaccination (Day 392). Count of participants. Unit: Participants

Measure	mRNA-1325 10 mcg n = 25	mRNA-1325 25 mcg n = 24	mRNA-1325 100 mcg n = 25	Placebo n = 16
Value	5	3	3	1

Population analysed: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to Day 392. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mRNA-1325 10 mcg	1 of 25 (4%)	24 of 25 (96%)	1 of 25
mRNA-1325 25 mcg	0 of 24 (0%)	23 of 24 (95.8%)	0 of 24
mRNA-1325 100 mcg	0 of 25 (0%)	25 of 25 (100%)	0 of 25
Placebo	0 of 16 (0%)	12 of 16 (75%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36682364Essink B, Chu L, Seger W, Barranco E, Le Cam N, Bennett H, Faughnan V, Pajon R, Paila YD, Bollman B, Wang S, Dooley J, Kalidindi S, Leav B. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023 May;23(5):621-633. doi: 10.1016/S1473-3099(22)00764-2. Epub 2023 Jan 19.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mRNA-1325 in people with Zika Virus, run by ModernaTX, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Solicited Adverse Events- Vaccination 1 (time frame: Up to 7 days post-vaccination 1 (up to 8 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03014089, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.