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

At a glance

Drugs Zika virus vaccine-Moderna (Primary)
Indications Zika virus infection
Focus Adverse reactions; First in man
Sponsors Moderna Therapeutics; Valera LLC

Most Recent Events

01 Jul 2019 Status changed from active, no longer recruiting to completed.
24 Apr 2019 Planned End Date changed from 1 Apr 2019 to 1 May 2019.
24 Apr 2019 Planned primary completion date changed from 1 Apr 2019 to 1 May 2019.

Trial Overview

Purpose

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

Primary Endpoints

Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI) and adverse events considered related to study drug

safety_issue: Yes
time_frame: Through 13 months of study participation

Other Endpoints

Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample

time_frame: Through 13 months of study participation^[1]

Diseases Treated

Indication	Qualifiers	Patient Segments
Zika virus infection	prevention	-

Subjects

Subject Type volunteers
Number
Planned: 90

Actual: 90
Sex male & female
Age Group 18-49 years; adult

Patient Inclusion Criteria

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

Patient Exclusion Criteria

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

Trial Details

Identifiers

Identifier	Owner
NCT03014089	ClinicalTrials.gov: US National Institutes of Health
mRNA1325P101	-
HHSO100201600029C	-

Organisations

Sponsors Moderna Therapeutics; Valera LLC
Affiliations Moderna Therapeutics; Valera LLC

Trial Dates

Initiation Dates
Actual : 21 Dec 2016
Primary Completion Dates
Planned : 01 May 2019

Actual : 01 Jul 2019
End Dates
Planned : 01 May 2019

Actual : 01 Jul 2019

Other Details

Design double-blind; multicentre; parallel; prospective; randomised
Phase of Trial Phase I
Location USA
Focus Adverse reactions; First in man

Interventions

Drugs	Route	Formulation
Zika virus vaccine-ModernaPrimary Drug	Intramuscular	Injection

mRNA-1325

Biological: mRNA-1325 (Escalating dose levels)

Placebo

0.9% sodium chloride
Other: Placebo

Trial Centres

Investigators

Download Data (CSV)

Investigator	Centre Name	Trial Centre Country
Moderna Medical Director 844-663-6762 show details	Moderna Therapeutics	-

Centres

Download Data (CSV)

Centre Name	Location	Trial Centre Country
-	Melbourne, Florida	USA
-	Peoria, Illinois	USA
-	San Diego, California	USA
Biomedical Advanced Research and Development Authority	-	-
Moderna Therapeutics	-	-

Trial History

Event Date	Event Type	Comment
10 Dec 2019	Other trial event	Last checked against ClinicalTrials.gov record. ClinicalTrials.gov: US National Institutes of Health Updated 10 Dec 2019
01 Jul 2019	Status change - completed	Status changed from active, no longer recruiting to completed. ClinicalTrials.gov: US National Institutes of Health Updated 08 Jul 2019
24 Apr 2019	Completion date	Planned End Date changed from 1 Apr 2019 to 1 May 2019. ClinicalTrials.gov: US National Institutes of Health Updated 29 Apr 2019
24 Apr 2019	Other trial event	Planned primary completion date changed from 1 Apr 2019 to 1 May 2019. ClinicalTrials.gov: US National Institutes of Health Updated 29 Apr 2019
29 Mar 2019	Completion date	Planned End Date changed from 1 Feb 2019 to 1 Apr 2019. ClinicalTrials.gov: US National Institutes of Health Updated 04 Apr 2019
29 Mar 2019	Other trial event	Planned primary completion date changed from 1 Feb 2019 to 1 Apr 2019. ClinicalTrials.gov: US National Institutes of Health Updated 04 Apr 2019
30 Oct 2018	Completion date	Planned End Date changed from 1 Sep 2018 to 1 Feb 2019. ClinicalTrials.gov: US National Institutes of Health Updated 12 Nov 2018
30 Oct 2018	Other trial event	Planned primary completion date changed from 1 Sep 2018 to 1 Feb 2019. ClinicalTrials.gov: US National Institutes of Health Updated 12 Nov 2018
22 Jan 2018	Other trial event	Planned primary completion date changed from 1 Nov 2017 to 1 Sep 2018. ClinicalTrials.gov: US National Institutes of Health Updated 29 Jan 2018
22 Jan 2018	Status change - active, no longer recruiting	Status changed from recruiting to active, no longer recruiting. ClinicalTrials.gov: US National Institutes of Health Updated 29 Jan 2018
13 Jan 2017	Other trial event	New source identified and integrated (ClinicalTrials.gov: NCT03014089). ClinicalTrials.gov: US National Institutes of Health Updated 13 Jan 2017
21 Sep 2016	New trial record	New trial record Updated 21 Sep 2016

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